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Journal Description

JMIR Formative Research publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. While the original focus was on the design of medical- and health-related research and technology innovations, JMIR Formative Research publishes studies from all areas of medical and health research.

Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help

  • define and understand populations in need of an intervention or public health program
  • create programs that are specific to the needs of those populations
  • ensure programs are acceptable and feasible to users before launching
  • improve the relationship between users and agencies/research groups
  • demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at health outcomes)

Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).

Formative research should be an integral part of developing or adapting programs, and should be used while the program is ongoing to help refine and improve program activities. Thus, formative evaluation can and should also occur in the form of a process evaluation alongside a summative evaluation such as an RCT.

This journal fills an important gap in the academic journals landscape, as it publishes sound and peer-reviewed formative research that is critical for investigators to apply for further funding, but that is usually not published in outcomes-focused medical journals aiming for impact and generalizability.

Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in high-impact flagship journals; thus, we encourage authors to submit - as a first step - their formative evaluations in JMIR Formative Research (and their evaluation protocols in JMIR Research Protocols). 

JMIR Formative Research has been accepted for indexing in PubMed and PubMed Central.

 

Recent Articles:

  • Source: Image created by the authors; Copyright: The Authors; URL: https://formative.jmir.org/2020/3/e15494; License: Licensed by JMIR.

    Mutual-Aid Mobile App for Emergency Care: Feasibility Study

    Abstract:

    Background: Improving the quality of patient care through the use of mobile devices is one of the hot topics in the health care field. In unwanted situations like an accident, ambulances and rescuers often require a certain amount of time to arrive at the scene. Providing immediate cardiopulmonary resuscitation (CPR) to patients might improve survival. Objective: The primary objective of this study was to evaluate the feasibility of an emergency and mutual-aid app model in Taiwan and to provide a reference for government policy. Methods: A structured questionnaire was developed as a research tool. All questionnaires were designed according to the technology acceptance model, and a Likert scale was used to measure the degree of agreement or disagreement. Moreover, in-depth interviews were conducted with six experts from medical, legal, and mobile app departments. Each expert was interviewed once to discuss feasible countermeasures and suggestions. Statistical Package for the Social Sciences (SPSS version 19; IBM Corp, Armonk, New York) was used to perform all statistical analyses, including descriptive statistics, independent sample t-tests, variance analysis, and Pearson correlation analysis. Results: We conducted this study between October 20, 2017, and November 10, 2017, at the Taipei Medical University Hospital. Questionnaires were distributed to medical personnel, visiting guests, family members, and volunteers. A total of 113 valid questionnaires were finally obtained after the exclusion of incomplete questionnaires. Cronbach α values for self-efficacy (perceived ease of use), use attitude (perceived usefulness), and use willingness and frequency were above .85, meeting the criterion of greater than .70. We observed that the reliability of each subquestion was acceptable and the values for use attitude (perceive usefulness) and use willingness and frequency were more than .90. Conclusions: The findings suggest that perceived ease of use and perceived usefulness of the app model affect use willingness. However, perceived usefulness had an intermediary influence on use willingness. Experts in law, medical, and technology fields consider that an emergency and mutual-aid model can be implemented in Taiwan. Along with the development of an emergency and mutual-aid app model, we recommend an increase in the number of automated external defibrillators per region and promotion of correct knowledge about CPR in order to decrease morbidity and mortality.

  • Source: Adobe Stock; Copyright: neonshot; URL: https://stock.adobe.com/ca/images/african-american-woman-walking-at-sunny-day/209626928?asset_id=209626928; License: Licensed by JMIR.

    A Walking Intervention Supplemented With Mobile Health Technology in Low-Active Urban African American Women With Asthma: Proof-of-Concept Study

    Abstract:

    Background: Physical inactivity is associated with worse asthma outcomes. African American women experience disparities in both physical inactivity and asthma relative to their white counterparts. We conducted a modified evidence-based walking intervention supplemented with mobile health (mHealth) technologies to increase physical activity (PA). Objective: This study aimed to assess the preliminary feasibility of a 7-week walking intervention modified for African American women with asthma. Methods: African American women with suboptimally controlled asthma were identified from a health system serving low-income minorities. At a baseline data collection visit, participants performed spirometry and incremental shuttle walk test, completed questionnaires, and were given an accelerometer to wear for 1 week. The intervention comprised an informational study manual and 3 in-person group sessions over 7 weeks, led by a nurse interventionist, in a community setting. The supplemental mHealth tools included a wearable activity tracker device (Fitbit Charge HR) and one-way text messages related to PA and asthma 3 times per week. A secure Web-based research platform, iCardia, was used to obtain Fitbit data in real time (wear time, moderate-to-vigorous physical activity [MVPA] and sedentary time) and send text messages. The feasibility of the intervention was assessed in the domains of recruitment capability, acceptability (adherence, retention, engagement, text messaging, acceptability, complaints, and concerns), and preliminary outcome effects on PA behavior (change in steps, duration, and intensity). Results: We approached 22 women, of whom 10 were eligible; 7 consented, enrolled and completed the study. Group session attendance was 71% (5/7), 86% (6/7), and 86% (6/7), respectively, across the 3 sessions. All participants completed evaluations at each group session. The women reported being satisfied or very satisfied with the program (eg, location, time, and materials). None of them had concerns about using, charging, or syncing the Fitbit device and app. Participants wore their Fitbit device for at least 10 hours per day in 44 out of the 49 intervention days. There was an increase in Fitbit-measured MVPA from week 1 (19 min/week, SD 14 min/week) to the last week of intervention (22 min/week, SD 12 min/week; Cohen d=0.24, 95% CI 0.1 to 6.4). A slight decrease in step count was observed from week 1 (8926 steps/day, SD 2156 steps/day) to the last week of intervention (8517 steps/day, SD 1612 steps/day; Cohen d=−0.21, 95% CI −876.9 to 58.9). Conclusions: The initial feasibility results of a 7-week community-based walking intervention tailored for African American women with asthma and supplemented with mHealth tools are promising. Modifications to recruitment, retention, and the intervention itself are needed. These findings support the need to conduct a further modified pilot trial to collect additional data on feasibility and estimate the efficacy of the intervention on asthma and PA outcomes.

  • Source: Image created by the Authors; Copyright: Mariana Curotto; URL: http://formative.jmir.org/2020/3/e14652/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Developing SMS Content to Promote Papanicolaou Triage Among Women Who Performed HPV Self-collection Test: Qualitative Study

    Abstract:

    Background: SMS interventions are effective in promoting a variety of health behaviors; however, there is limited information regarding the use of SMS for cervical cancer screening and follow-up care. The Application of Communication and Information Technologies to Self-Collection study aims to evaluate a multicomponent mobile health intervention to increase triage adherence among women with human papillomavirus (HPV)–positive self-collected tests in Jujuy, Argentina. Here, we describe the formative results used to design the content of the SMS to be tested in the trial. Objective: This study aimed to understand the cultural and contextual elements, women’s beliefs, and perceptions regarding the use of SMS by the health care system and women’s preferences about the message content. Methods: We conducted five focus groups (FGs), stratified by rural or urban residence and age. All participants were aged 30 years or older and had performed HPV self-collection. Participatory techniques, including brainstorming, card-based classification, and discussions were used to debate the advantages and disadvantages of messages. We openly coded the discussions for agreements and preferences regarding the SMS content. Messages for both HPV-negative and HPV-positive women were validated through interviews with health authorities and 14 HPV-tested women. The final versions of the messages were pilot-tested. Results: A total of 48 women participated in the FGs. Participants rejected receiving both negative and positive HPV results by SMS because, for them, the delivery of results should be done in a face-to-face interaction with health professionals. They stressed the importance of the SMS content informing them that results were available for pick up and reflecting the kind of relationship that they have with the community health workers and the nearest health center. Women considered that a personalized SMS was important, as was the use of a formal yet warm tone. Owing to confidentiality issues, not using the word “HPV” was also a key component of the desired SMS content; therefore, the final message included the term “self-collection” without the mention of HPV infection. Results from the validation stage and pilot test showed high acceptability of the final version of the message. Conclusions: The results suggest that SMS is accepted when notifying women about the availability of the HPV test result, but it should not replace the delivery of results in face-to-face, doctor-patient encounters. In addition, messages must be tailored and must have a persuasive tone to motivate women to adhere to the triage.

  • Source: Unsplash; Copyright: Brooke Cagle; URL: https://unsplash.com/photos/g1Kr4Ozfoac; License: Licensed by JMIR.

    Understanding Students’ Mental Well-Being Challenges on a University Campus: Interview Study

    Abstract:

    Background: Research shows that emerging adults face numerous stressors as they transition from adolescence to adulthood. This paper investigates university students’ lived experiences of maintaining mental well-being during major life events and challenges associated with this transitional period. As we continue to design health technology to support students’ mental health needs, it is imperative to understand the fundamental needs and issues particular to this phase of their life to effectively engage and lower the barriers to seeking help. Objective: This study first aimed to understand how university students currently seek and receive support to maintain their mental well-being while going through frequent life events during this period of emerging adulthood. The study then aimed to provide design requirements for how social and technical systems should support the students’ mental well-being maintenance practice. Methods: Semistructured interviews with 19 students, including graduate and undergraduate students, were conducted at a large university in the Midwest in the United States. Results: This study’s findings identified three key needs: students (1) need to receive help that aligns with the perceived severity of the problem caused by a life event, (2) have to continuously rebuild relationships with support givers because of frequent life events, and (3) negotiate tensions between the need to disclose and the stigma associated with disclosure. The study also identified three key factors related to maintaining mental well-being: time, audience, and disclosure. Conclusions: On the basis of this study’s empirical findings, we discuss how and when help should be delivered through technology to better address university students’ needs for maintaining their mental well-being, and we argue for reconceptualizing seeking and receiving help as a colearning process.

  • Women looks at her diagnostic test results on the online patient portal. Source: Image created by Saltro; Copyright: Saltro; URL: https://formative.jmir.org/2020/3/e17060; License: Licensed by the authors.

    Patients’ Attitudes Toward an Online Patient Portal for Communicating Laboratory Test Results: Real-World Study Using the eHealth Impact Questionnaire

    Abstract:

    Background: Communicating laboratory test results online has several advantages for patients, such as improving clinical efficiency and accessibility, thereby helping patients to take an active role in managing their health. Objective: This study aimed to investigate the experiences and self-efficacy of patients using an online patient portal that communicates laboratory test results. Methods: We used the online-administered eHealth Impact Questionnaire to explore patients’ attitudes toward the portal. Patients visiting the portal were asked to complete the questionnaire. The subscale Information and Presentation assessed the usability of the patient portal and the subscale Motivation and Confidence to Act assessed self-efficacy to determine whether patients were motivated to act on the presented information. We used a cutoff score of 65 or greater to determine whether the portal was rated positively. Results: The questionnaire was completed by 354 of 13,907 patients who viewed their laboratory results in the patient portal, with a response rate of 2.55%. The mean Information and Presentation score was 67.70 (SD 13.12) and the mean Motivation and Confidence to Act score was 63.59 (SD 16.22). We found a positive, significant correlation between the 2 subscales (r345=.77, P<.001). Conclusions: Patients participating in the study rated the usability of the portal positively. However, the portal only slightly helped patients to take an active role in managing their own health. The low response rate precludes generalization of the results. Future research should examine avenues to further increase patients’ self-efficacy and study whether portal acceptability differs in subgroups. Patient portals conveying laboratory test results in understandable language seem usable and potentially provide a viable way to help patients take a more active role in managing their own health.

  • Feasture image for homepage (senior woman with ipad). Source: iStock by Getty Images; Copyright: annebaek; URL: https://www.istockphoto.com/no/photo/browsing-through-family-photos-gm483662887-38172250; License: Licensed by the authors.

    Mobile App to Help People With Chronic Illness Reflect on Their Strengths: Formative Evaluation and Usability Testing

    Abstract:

    Background: Supporting patient engagement and empowerment is increasingly seen as essential in providing person-centered health care to people with chronic illness. Mobile apps helping patients reflect on their concerns as preparation for consultations with their health care providers can have beneficial effects on the consultation quality. However, apps focusing on empowerment and personal strengths are still scarce. Objective: This study aimed to (1) develop a mobile app to support patients with rheumatic diseases in reflecting on their strengths in preparation for consultations with health care providers and (2) explore patients’ perceived usability of the app in a nonclinical test setting. Methods: A prototype app was developed based on input from patients and health care providers, as reported in previous studies. The app was designed for use in self-management support settings aiming to promote awareness of strengths and to focus attention on strengths in the patient-health care provider dialogue. The features included in the prototype were as follows: (1) introduction to the topic of strengths, (2) list of examples of strengths to promote reflection and registration of own strengths, (3) summary of registered strengths, (4) value-based goal setting, (5) linking of strengths to goals, (6) summary of all registrations, and (7) options to share summary digitally or as a print version. In this study, the app was refined through a formative evaluation with patients and health care providers recruited from a specialized rheumatology hospital unit. Patients’ perceptions of the app’s usability were explored in a test setting with self-report measurements and semistructured interviews. The interviews were audiotaped, transcribed, and analyzed with directed content analysis. Data from questionnaires were analyzed with descriptive statistics. Results: Developmental and formative evaluation included 18 patients and 7 health care providers. The evaluation resulted in minor adjustments to the prototype but no major changes in features. The usability testing included 12 patients. All participants found the usability acceptable; the median score on the System Usability Scale was 86.3 (range 70-100). All reported that it was meaningful and relevant to use the app. Out of 12 participants, 9 (75%) reported becoming more aware of their own strengths by using the app; 1 (8%) disagreed and 2 (17%) provided a neutral response. The results on the goal-related feature were mixed, with half of the patients finding it useful to link strengths to concrete goals. A statistically significant positive change from pre- to postintervention was identified on measures of self-efficacy and negative emotions. Conclusions: In this formative evaluation of a mobile app to promote patients’ reflections on their strengths, patients perceived the app as meaningful and supporting awareness. The results suggest the usefulness of building in functionality to support use of strengths and goal attainment. Further studies on efficacy and usability in a clinical setting, including health care providers, are needed.

  • Source: The Authors/ Placeit; Copyright: JMIR Publications; URL: http://formative.jmir.org/2020/2/e15919/; License: Creative Commons Attribution (CC-BY).

    Effectiveness of the Fun for Wellness Web-Based Behavioral Intervention to Promote Physical Activity in Adults With Obesity (or Overweight): Randomized...

    Abstract:

    Background: Insufficient physical activity in the adult population is a global pandemic. Fun for Wellness (FFW) is a self-efficacy theory- and Web-based behavioral intervention developed to promote growth in well-being and physical activity by providing capability-enhancing opportunities to participants. Objective: This study aimed to evaluate the effectiveness of FFW to increase physical activity in adults with obesity in the United States in a relatively uncontrolled setting. Methods: This was a large-scale, prospective, double-blind, parallel-group randomized controlled trial. Participants were recruited through an online panel recruitment company. Adults with overweight were also eligible to participate, consistent with many physical activity–promoting interventions for adults with obesity. Also consistent with much of the relevant literature the intended population as simply adults with obesity. Eligible participants were randomly assigned to the intervention (ie, FFW) or the usual care (ie, UC) group via software code that was written to accomplish equal allocations to the FFW and UC groups. Data collection was Web based, fully automated, and occurred at three time points: baseline, 30 days after baseline (T2), and 60 days after baseline (T3). Participants (N=461) who were assigned to the FFW group (nFFW=219) were provided with 30 days of 24-hour access to the Web-based intervention. A path model was fit to the data consistent with the FFW conceptual model for the promotion of physical activity. Results: There was evidence for a positive direct effect of FFW on transport-related physical activity self-efficacy (beta=.22, P=.02; d=0.23), domestic-related physical activity self-efficacy (beta=.22, P=.03; d=0.22), and self-efficacy to regulate physical activity (beta=.16, P=.01; d=0.25) at T2. Furthermore, there was evidence for a positive indirect effect of FFW on physical activity at T3 through self-efficacy to regulate physical activity at T2 (beta=.42, 95% CI 0.06 to 1.14). Finally, there was evidence for a null direct effect of FFW on physical activity (beta=1.04, P=.47; d=0.07) at T3. Conclusions: This study provides some initial evidence for both the effectiveness (eg, a positive indirect effect of FFW on physical activity through self-efficacy to regulate physical activity) and the ineffectiveness (eg, a null direct effect of FFW on physical activity) of the FFW Web-based behavioral intervention to increase physical activity in adults with obesity in the United States. More broadly, FFW is a scalable Web-based behavioral intervention that may effectively, although indirectly, promote physical activity in adults with obesity and therefore may be useful in responding to the global pandemic of insufficient physical activity in this at-risk population. Self-efficacy to regulate physical activity appears to be a mechanism by which FFW may indirectly promote physical activity in adults with obesity. Trial Registration: ClinicalTrials.gov NCT03194854; https://clinicaltrials.gov/ct2/show/NCT03194854.

  • Use of myED. Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2020/2/e16410/; License: Licensed by JMIR.

    A Patient-Centered Information System (myED) for Emergency Care Journeys: Design, Development, and Initial Adoption

    Abstract:

    Background: Medical care is highly complex in that it addresses patient-centered health goals that require the coordination of multiple care providers. Emergency department (ED) patients currently lack a sense of predictability about ED procedures. This increases frustration and aggression. Herein, we describe a system for providing real-time information to ED patients regarding the procedures in their ED medical journey. Objective: This study aimed to develop a system that provides patients with dynamically updated information about the specific procedures and expected waiting times in their personal ED journey, and to report initial evaluations of this system. Methods: To develop the myED system, we extracted information from hospital databases and translated it using process mining and user interface design into a language that is accessible and comprehensible to patients. We evaluated the system using a mixed methods approach that combined observations, interviews, and online records. Results: Interviews with patients, accompanying family members, and health care providers (HCPs) confirmed patients’ needs for information about their personal ED journey. The system developed enables patients to access this information on their personal mobile phones through a responsive website. In the third month after deployment, 492 of 1614 (30.48%) patients used myED. Patients’ understanding of their ED journey improved significantly (F8,299=2.519; P=.01), and patients showed positive reactions to the system. We identified future challenges, including achieving quick engagement without delaying medical care. Salient reasons for poor system adoption were patients’ medical state and technological illiteracy. HCPs confirmed the potential of myED and identified means that could improve patient experience and staff cooperation. Conclusions: Our iterative work with ED patients, HCPs, and a multidisciplinary team of developers yielded a system that provides personal information to patients about their ED journey in a secure, effective, and user-friendly way. MyED communicates this information through mobile technology. This improves health care by addressing patients’ psychological needs for information and understanding, which are often overlooked. We continue to test and refine the system and expect to find positive effects of myED on patients’ ED experience and hospital operations.

  • Diabetes and Emotional Health: A handbook and toolkit for health professionals supporting adults with type 1 or type 2 diabetes. Source: Diabetes Victoria; Copyright: Colin Carey; URL: http://formative.jmir.org/2020/2/e15007/; License: Licensed by the authors.

    The Diabetes and Emotional Health Handbook and Toolkit for Health Professionals Supporting Adults With Type 1 and Type 2 Diabetes: Formative Evaluation

    Abstract:

    Background: Health professionals have expressed unmet needs, including lacking the skills, confidence, training, and resources needed to properly attend to the psychological needs of people with diabetes. Objective: Informed by needs assessments, this study aimed to develop practical, evidence-based resources to support health professionals to address the emotional needs of adults with type 1 or type 2 diabetes. Methods: We developed a new handbook and toolkit informed by formative evaluation, including literature reviews, stakeholder consultation and review, and a qualitative study. In the qualitative study, health professionals participated in interviews after reading sections of the handbook and toolkit. Results: The literature review uncovered that psychological problems are common among adults with diabetes, but health professionals lack resources to provide related support. We planned and drafted resources to fill this unmet need, guided by stakeholder consultation and an Expert Reference Group (ERG). Before finalizing the resources, we implemented feedback received from stakeholders (ERG, health professionals, academics, and people with diabetes). The resulting resources were the practical, evidence-based Diabetes and Emotional Health handbook and toolkit. A total of 19 health professionals took part in the qualitative study about the handbook and toolkit. They viewed the resources favorably, felt empowered to support people with diabetes experiencing psychological problems, and felt motivated to share the resources with others. Some gave examples of how they had used the handbook in clinical practice. A perceived highlight was the inclusion of a process model outlining 7 steps for identifying and supporting people with emotional problems: the 7 A’s model. With funding from the National Diabetes Services Scheme (NDSS), more than 2400 copies of Diabetes and Emotional Health have been distributed. It is freely available on the Web. The NDSS is an initiative of the Australian Government administered with the assistance of Diabetes Australia. Conclusions: The new evidence-based resources are perceived by stakeholders as effective aids to assist health professionals in providing emotional support to adults with diabetes. The 7 A’s model may have clinical utility for routine monitoring of other psychological and health-related problems, as part of person-centered clinical care.

  • Source: Pexels.com; Copyright: Christina Morillo; URL: https://www.pexels.com/photo/woman-wearing-white-button-up-shirt-sitting-in-front-of-table-1181726/; License: Licensed by JMIR.

    Using an Electronic Medication Event–Monitoring System for Antiretroviral Therapy Self-Management Among African American Women Living With HIV in Rural...

    Abstract:

    Background: HIV remains a significant health issue in the United States and disproportionately affects African Americans. African American women living with HIV (AAWH) experience a particularly high number of barriers when attempting to manage their HIV care, including antiretroviral therapy (ART) adherence. To enable the development and assessment of effective interventions that address these barriers to support ART adherence, there is a critical need to understand more fully the use of objective measures of ART adherence among AAWH, including electronic medication dispensers for real-time surveillance. Objective: This study aimed to evaluate the use of the Wisepill medication event–monitoring system (MEMS) and compare the objective and subjective measures of ART adherence. Methods: We conducted a 30-day exploratory pilot study of the MEMS among a convenience sample of community-dwelling AAWH (N=14) in rural Florida. AAWH were trained on the use of the MEMS to determine the feasibility of collecting, capturing, and manipulating the MEMS data for an objective measure of ART adherence. Self-reported sociodemographic information, including a self-reported measure of ART adherence, was also collected from AAWH. Results: We found that the majority of participants were successful at using the electronic MEMS. Daily use of the MEMS tended to be outside of the usual time participants took their medication. Three 30-day medication event patterns were found that characterized ART adherence, specifically uniform and nonuniform medication adherence and nonuniform medication nonadherence. There were relatively few MEMS disruptions among study participants. Overall, adjusted daily ART adherence was 81.08% and subjective ART adherence was 77.78%. Conclusions: This pilot study on the use and evaluation of the Wisepill MEMS among AAWH in rural Florida is the first such study in the United States. The findings of this study are encouraging because 10 out of 12 participants consistently used the MEMS, there were relatively few failures, and objective adjusted daily and overall subjective ART adherence were very similar. On the basis of these findings, we think researchers should consider using the Wisepill MEMS in future studies of AAWH and people living with HIV in the United States after taking into account our practical suggestions. The following practical considerations are suggested when measuring objective medication adherence: (1) before using an MEMS, be familiar with the targeted populations’ characteristics; (2) choose an MEMS that aligns with the participants’ day-to-day activities; (3) ensure the MEMS’ features and resulting data support the research goals; (4) assess the match among the user’s ability, wireless features of the MEMS, and the geographic location of the participants; and (5) consider the cost of MEMS and the research budget.

  • Participants using the INTER-ACT app. Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2020/2/e16090/; License: Licensed by JMIR.

    Development and Field Evaluation of the INTER-ACT App, a Pregnancy and Interpregnancy Coaching App to Reduce Maternal Overweight and Obesity: Mixed Methods...

    Abstract:

    Background: The interpregnancy and pregnancy periods are important windows of opportunity to prevent excessive gestational weight retention. Despite an overwhelming number of existing health apps, validated apps to support a healthy lifestyle between and during pregnancies are lacking. Objective: To describe the development and evaluation of the INTER-ACT app, which is part of an interpregnancy and pregnancy lifestyle coaching module, to prevent excessive weight gain in pregnancy and enhance optimal weight and a healthy lifestyle in the interpregnancy period. Methods: A mixed methods design was used to identify the needs of health care providers and end users, according to 15 semistructured interviews, two focus groups, and two surveys. The user interface was evaluated in a pilot study (N=9). Results: Health care providers indicated that a mobile app can enhance a healthy lifestyle in pregnant and postpartum women. Pregnant women preferred graphic displays in the app, weekly notifications, and support messages according to their own goals. Both mothers and health care providers reported increased awareness and valued the combination of the app with face-to-face coaching. Conclusions: The INTER-ACT app was valued by its end users because it was offered in combination with face-to-face contact with a caregiver.

  • Source: The Authors/ Placeit; Copyright: JMIR Publications; URL: http://formative.jmir.org/2020/2/e14189/; License: Creative Commons Attribution (CC-BY).

    Usability of the Turkish Translation of the Dutch Talking Touch Screen Questionnaire for Physical Therapy Patients With a Turkish Background: Qualitative Study

    Abstract:

    Background: The Turkish translation of the Dutch Talking Touch Screen Questionnaire (TTSQ) has been developed to help physical therapy patients with a Turkish background in the Netherlands to autonomously elucidate their health problems and impairments and set treatment goals, regardless of their level of health literacy. Objective: The aim of this study was to evaluate the usability of the Turkish TTSQ for physical therapy patients with a Turkish background with diverse levels of health literacy and experience in using mobile technology. Methods: The qualitative Three-Step Test-Interview method was carried out to gain insight into the usability of the Turkish TTSQ. A total of 10 physical therapy patients participated. The interview data were analyzed using a thematic content analysis approach aimed at determining the accuracy and completeness with which participants completed the questionnaire (effectiveness), the time it took participants to complete the questionnaire (efficiency), and the extent to which the participants were satisfied with the ease of use of the questionnaire (satisfaction). The problems encountered by the participants in this study were given a severity rating, which was used to provide a rough estimate of the need for additional usability improvements. Results: No participant in this study was able to complete the questionnaire without encountering at least one usability problem. A total of 17 different kinds of problems were found. On the basis of their severity score, 3 problems that should be addressed during future development of the tool were “Not using the navigation function of the photo gallery in Question 4 causing the participant to not see all presented response items;” “Touching the text underneath a photo in Question 4 to select an activity instead of touching the photo itself, causing the activity not to be selected;” and “Pushing too hard or tapping too softly on the touch screen causing the touch screen to not respond.” The data on efficiency within this study were not valid and are, therefore, not reported in this study. No participant was completely satisfied or dissatisfied with the overall ease of use of the Turkish TTSQ. Two participants with no prior experience of using tablet computers felt that, regardless of what kinds of improvement might be made, it would just be too difficult for them to learn to work with the device. Conclusions: As with the Dutch TTSQ, the Turkish TTSQ needs improvement before it can be released. The results of this study confirm the conclusion of the Dutch TTSQ study that participants with low levels of education and little experience in using mobile technology are less able to operate the TTSQ effectively. Using a Dutch speaking interviewer and Turkish interpreter has had a negative effect on data collection in this study.

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  • RepPer: Perception of Psychiatric Disorders on Twitter in French

    Date Submitted: Mar 3, 2020

    Open Peer Review Period: Mar 3, 2020 - Apr 28, 2020

    Background: With the advent of digital technology and specifically user generated contents in social media, new ways emerged for studying possible stigma of people in relation with mental health. Seve...

    Background: With the advent of digital technology and specifically user generated contents in social media, new ways emerged for studying possible stigma of people in relation with mental health. Several pieces of work studied the discourse conveyed about psychiatric pathologies on Twitter considering mostly tweets in English and a limited number of psychiatric disorders terms. This paper proposes the first study to analyze the use of a wide range of psychiatric terms in tweets in French. Objective: Our aim is to study how generic, nosographic and therapeutic psychiatric terms are used on Twitter in French. More specifically, our study has three complementary goals: (1) to analyze the types of psychiatric word use namely medical, misuse, irrelevant, (2) to analyze the polarity conveyed in the tweets that use these terms (positive/negative/neural), and (3) to compare the frequency of these terms to those observed in related work (mainly in English ). Methods: Our study has been conducted on a corpus of tweets in French posted between 01/01/2016 to 12/31/2018 and collected using dedicated keywords. The corpus has been manually annotated by clinical psychiatrists following a multilayer annotation scheme that includes the type of word use and the opinion orientation of the tweet. Two analysis have been performed. First a qualitative analysis to measure the reliability of the produced manual annotation, then a quantitative analysis considering mainly term frequency in each layer and exploring the interactions between them. Results: One of the first result is a resource as an annotated dataset . The initial dataset is composed of 22,579 tweets in French containing at least one of the selected psychiatric terms. From this set, experts in psychiatry randomly annotated 3,040 tweets that corresponds to the resource resulting from our work. The second result is the analysis of the annotations; it shows that terms are misused in 45.3% of the tweets and that their associated polarity is negative in 86.2% of the cases. When considering the three types of term use, 59.5% of the tweets are associated to a negative polarity. Misused terms related to psychotic disorders (55.5%) are more frequent to those related to mood disorders (26.5%). Conclusions: Some psychiatric terms are misused in the corpora we studied; which is consistent with the results reported in related work in other languages. Thanks to the great diversity of studied terms, this work highlighted a disparity in the representations and ways of using psychiatric terms. Moreover, our study is important to help psychiatrists to be aware of the term use in new communication media such as social networks which are widely used. This study has the huge advantage to be reproducible thanks to the framework and guidelines we produced; so that the study could be renewed in order to analyze the evolution of term usage. While the newly build dataset is a valuable resource for other analytical studies, it could also serve to train machine learning algorithms to automatically identify stigma in social media.

  • Implementation of a standardized initial assessment for demand management in outpatient emergency care in Germany: an early qualitative process evaluation

    Date Submitted: Feb 27, 2020

    Open Peer Review Period: Feb 27, 2020 - Apr 23, 2020

    Background: Inadequate assessment of the severity and urgency of a medical problem is one of the factors contributing to unnecessary emergency department (ED) visits. The implementation of a software-...

    Background: Inadequate assessment of the severity and urgency of a medical problem is one of the factors contributing to unnecessary emergency department (ED) visits. The implementation of a software-based instrument for standardized initial assessment (SmED) aims to support healthcare professionals and steer patients to the right healthcare provider. This study aimed to explore the implementation process of SmED from a user perspective. Objective: This study aims at evaluating the overall perception of SmED by healthcare professionals using the software, to examine to what extent SmED influences workload and work routines of healthcare professionals, and which factors are associated with the use of SmED. Methods: An early qualitative process evaluation on the basis of interviews was carried out alongside the implementation of SmED in 26 outpatient emergency care services within 11 federal states in Germany. Participants were 30 healthcare professionals who work with SmED either at the joint central contact points of the outpatient emergency care service and the emergency departments of hospitals ("Joint counter", German “Gemeinsamer Tresen”) or at the initial telephone contact points of the outpatient emergency care service (116117). Matrix-based Framework Analysis was applied to analyse interview-data. Results: Healthcare professionals perceived that workload increased initially, due to additional time needed per patient. When using SmED more frequently, and over a longer time period, they gained routine and time need per call/patient decreased. SmED was perceived to support decision-making regarding urgency for medical treatment, but not all types of patients were eligible. Technical problems, lack of integration with other software, and lack of practicably during peak time affected the implementation of SmED. Conclusions: Initial experiences with SmED were in general positive, but also highlighted organizational issues that need to be addressed to enhance sustainability. Clinical Trial: The study has been registered at the German Clinical Trial Register prior to the start of the study, registration number: DRKS00017014

  • Internet-delivered vs face-to-face cognitive behavior therapy for anxiety disorders: systematic review and meta-analysis

    Date Submitted: Feb 16, 2020

    Open Peer Review Period: Feb 16, 2020 - Apr 12, 2020

    Background: Over the last twenty years, Internet-delivered cognitive behavior therapy (ICBT) has been tested in a large number of randomized controlled trials, often with positive results. However not...

    Background: Over the last twenty years, Internet-delivered cognitive behavior therapy (ICBT) has been tested in a large number of randomized controlled trials, often with positive results. However not widely known about the efficacy of ICBT as compared to face-to-face cognitive behavior therapy (CBT). In the present systematic review and meta-analysis, ICBT for anxiety disorders were directly compared to face- to-face CBT within the same trial. This study aimed to reinvestigate the efficacy of ICBT compared to face-to-face cognitive behavior therapy (CBT) for anxiety disorders. A total of 8 studies Out of the 236 articles screened, met all inclusion criteria. Results showed a pooled effect size at post-treatment of Hedges g = .01 (95% CI, -0.16 to 0.18), indicating that ICBT and face-to-face treatment created equivalent overall effects. While the overall results indicate equivalence, there have been few studies of the anxiety disorders so far, and for the majority, ICBT has not been compared against face-to-face treatment. Therefore, more research is needed to establish the general equivalence of the two treatment formats. Objective: Internet-based cognitive behavior therapy (ICBT) is almost the same as CBT but delivered through the internet in which a client completes some materials and modules through a website (Anderson et al., 2011). The patient is also guided by an online therapist that provides support through clarifying information, monitoring the progress, giving feedback to homework and allowing the patient access to the sequential treatment steps (Anderson et al., 2011). ICBT has many advantages compared to classic treatment: it requires less therapist time, in adults about 85% less therapist time per week and it’s not limited to the office hours. It also can be performed without the distances’ limitation between therapist and patient, which can decrease the possible risk of stigma in visiting a therapist, and children and their parents can be involved in the therapy program without missing school or work (Vigerland et al., 2016). Several forms of ICBT are designed by searchers from all around the world, most have a therapist, guiding the patient during treatment. Treatments are structured, usually includes up to 15 training modules, which are roughly equivalent to the number of face-to-face CBT sessions (Lindefors & Anderson, 2016). These treatments are different from many aspects, such as technical solutions, the amount of therapist's support and diagnostic processes (Lindefors et al., 2012). They have also some features in common including all are based on cognitive-behavioral approach including components of face-to-face CBT such as exposure, psycho-education and treatment during 8 to 15 weeks. Most of these programs use text messages as the main form of communication between the patient and the therapist. They have an integrated assessment system and assignment in the internet-based therapy program (Lindefors & Anderson, 2016). Since early treatment researches on ICBT that were done in the late 1990s (Andersson, Carlbring, & Lindefors, 2016), more than 200 randomized controlled trials have been issued, often with hopeful outcomes showing that ICBT is clinically effective when compared to controls (Andersson, Carlbring, & Hadjistavropoulos, 2017). Besides a few numbers of long-term, follow-up studies have indicated that the ICBT effects are kept for if five years post-treatment (Hedman, et al., 2011). Despite promising outcomes in control trials, in which ICBT is often compared with waiting list control groups, an important question is how well guided ICBT compares against face-to-face treatment (Carlbring et al., 2017). This was studied in a meta-analysis by Andersson, Cuijpers, Carlbring, Riper, and Hedman (2014) that consisted of 13 studies (N=1053) published till June 2013. The results indicated a pooled effect size at a post-treatment of Hedges g= -.01 (95% Cl, -.13 to .12), suggesting that ICBT and face-to-face treatment result in equal overall effects. This study was updated in 2018 with 20 studies (N=1418), the results showed some effects of CBT and ICBT for the psychiatric and somatic disorders. This approach offers a reasonable alternative to clinic-based therapy with advantages of low cost, reduced therapist time and greater accessibility for families who have difficulty accessing clinic-based CBT (Boettcher, et al, 2013; Spence et al, 2011). One of the most important areas that were well researched on ICBT is anxiety disorders (Andersson, 2009). Several studies showed that internet-based treatments have the same effects as face-to-face studies for different types of anxiety disorders including, panic disorder, social anxiety, fear of public speaking, fear of spider (Hedman et al, 2011; Spence et al, 2011; Boetela et al, 2010; Bergstrom et al, 2010; Andrew et al, 2011; Anderson et al, 2009). Spence and colleagues (2011) compared the effect of online vs clinic-based CBT in 115 anxious adolescents. Results showed a great reduction in both groups in comparison to the waiting list group (online group’s d=2.12; clinic group’s d=3.42). Also, these improvements were kept at 6 and 12 months follow-up. So ICBT is equally effective as a face-to-face treatment of anxiety disorders in adolescents. In another study, Hedman and colleagues (2011), investigated the cost-effectiveness of ICBT compared to Cognitive-Behavioral Group Therapy (CBGT) in the treatment of social anxiety. Results showed that the reduction of social anxiety was the same in both treatments. They also conducted a 4-year follow-up and found that participants in both treatment groups made large improvements from baseline to 4-year follow-up on the primary outcome measure (d=1.34-1.48). Anderson and colleagues (2009), compared guided ICBT with one session of live exposure therapy in 30 patients with spider phobia. The results of the research also didn’t show any difference in both groups (d=1.84; 2.58 for the internet and live-exposure groups respectively, at post-treatment). One more study, conducted by Bergstrom and colleagues, compared the effectiveness of Internet and group CBT for panic disorder in a randomized trial. 113 patients were randomly assigned to guided ICBT group (n=53) or group CBT (n=60). Again, both treatments showed a significant reduction in symptoms. For the Internet treatment, the within-group effect size (pre-post) was d=1.73, and for the group treatment, it was 1.63. Effects were maintained at 6 months follow-up. This study suggests the equal effectiveness of both treatments. Although studies in the last decade have consistently shown that ICBT is an effective treatment for anxiety disorders (Hedman et al., 2011) with the same outcomes in comparison to face to face treatment, a lot of people never receive treatment or get it after years of pain(Anderson,2009; Vigerland, 2015). Also, according to some studies, anxiety disorders, despite being extremely prevalent, have a little possibility of being treated than other psychiatric disorders (Vigerland, 2015). On the other hand, the efficacy of ICBT in different types of disorders may vary due to their characteristics (Andresson, 2009), therefore there is a crucial need to do more researches specifically to different anxiety disorders. As this area is moving ahead quickly and many new studies have been published, also to the best of our knowledge, no earlier review has targeted anxiety disorders for comparing internet-based and face to face cognitive behavior therapy, there is a need for a systematic review and meta-analysis focusing on this area. This study aimed to compare the efficacy of internet-based vs face-to-face CBT for anxiety disorders. We conducted a systematic review and meta-analysis of studies directly comparing the two treatment formats. According to strong research literature, we hypothesized that ICBT and face-to-face CBT would produce equivalent treatment effects. Methods: Methods Data sources and search strategy To identify studies published until 2019, systematic searches in PubMed, Scopus, ProQuest, Emerald and Science direct were conducted. The search strategy employed a combination of search terms related to anxiety disorders (anxiety, anxiety disorders, fear, panic disorder, social phobia, social anxiety, generalized anxiety disorder, post-traumatic stress disorder, specific phobia, obsessive-compulsive disorder) and internet (internet, online, web, computer, computerized, internet-based, internet-delivered, internet delivery) and CBT (behavior, cognitive, therapy, treatment). The complete search strings can be viewed in Fig 1. Study Selection Articles were included if a) compare therapist-guided ICBT to face-to-face treatment using a randomized controlled design, b) use interventions aimed at the treatment of anxiety disorders (and not, for example, prevention or mere psychoeducation), c) investigate a form of ICBT where the internet treatment was the main component and not a secondary complement to other therapies, d) the internet treatment group be supported by an online therapist, e) be written in English. There were no restrictions regarding ages. Each article was independently assessed by first and corresponding authors at title, abstract and full-text level to evaluate inclusion or exclusion according to the criteria presented above. In the cases with disagreement on inclusion decision, the full-text level was reviewed for reaching consensus. Data Extraction The following variables were extracted from the included studies for further analysis: country, first author, year published, type of disorder, participant age interval, sample size in both internet-based and face to face groups, outcome measure, Type of outcome measure (categorized as “clinician-rated”, “self-rated”, “parent-rated” or a “physiological measure”), Pre- and post-treatment means and standard deviations of outcome measures, number of modules, sessions; weeks of therapy in both groups and assessment of study quality Assessment of Study Quality All included studies were assessed by quality assessment instrument (Moncrieff, Churchill, Drummond, & Mcguire, 2001), a scale of study quality on 23 different characteristics, each assessed on a 3-point scale (0 = poor, 1 = fair, 2 = good) including ratings on appropriate sample size, study design, statistical analyses and presentation of outcomes. In the original article the mean ratings of 30 mental health trials were between 16.3(SD=6.3) and 20.9(SD=9.0) and the interrater reliability was in the great range (r=0.75 to 0.86) (Moncrieff et al., 2001). Each article was evaluated independently by two authors. The mean of these scores was considered as the quality score of study. Statistical Analysis Data were analyzed by Cochrane Review Manager (RevMan) version 5.3 (Higgins & Greens, 2011 available from www.cochrane-handbook.org). Using the chosen outcome in each study, a random-effects meta-analysis was carried out, see Table1. In the primary meta-analyses, we evaluated the effect of ICBT compared to face-to-face treatment using the standardized mean difference at post-treatment (Hedges’ g) as the outcome, meaning that the difference between treatments was divided by the pooled standard deviation. If both intention-to-treat and per-protocol data were presented, the earlier estimation was used in the meta-analysis. Estimates of treatment effects were conducted using all included studies as well as separately for each anxiety disorder (e.g. social anxiety). Possible differences in dropout rates between ICBT and face-to-face treatment were analyzed using meta-analytic logistic regression. All pooled analyses were conducted in a random-effects model framework, assuming variation in true effects in the included studies and accounting for the hypothesized distribution of effects (Carlbring, et al, 2017). Forest plots were also inspected to assess variation in effects across studies. Results: Results Systematic Review Included Studies The database search resulted in 236 articles, which after screening 8 of them met all inclusion criteria and were included in the study (see Fig. 1). One of them (Hedman et al., 2014) was a long term follow up of another study (Hedman et al., 2011) and are not reported separately. Thus, 8 studies were included in the systematic review of the meta-analyses (n=537). The total number of 8 studies investigated ICBT against some form of CBT (individual format, n = 4 or group format, n = 4). In terms of disorder studied, three of the studies targeted social anxiety (Hedman et al., 2011; Andrews et al., 2011; Hedman et al., 2014), two of them panic disorder (Carlbring et al., 2005; Bergstrom et al., 2010), one adolescence anxiety (Spence et al., 2011), one spider phobia (Andersson et al., 2009), and a fear of public speaking (Botella et al., 2010). The total number of participants was 348 in ICBT and 316 in face-to-face conditions. The studies were carried out in Australia, Spain, and Sweden. The smallest study had 47 participants, and the largest had 126. All studies were published between the years 2005 and 2014. The characteristics of each study are presented in Table 1. Duration and intensity ICBT interventions included between 4 and 15 treatment modules (M= 10, Md= 10) that were to be completed in 5 to 15 weeks (M= 10.87, Md= 10). Face-to-face treatments consist of 2 and 15 sessions that were held between 1 and 15 weeks. Five interventions have a “once a week” format with approximately the same number of treatment modules and weeks. One intervention had more weeks than modules in ICBT (Andrews et al., 2011), two had more modules than weeks (Andersson et al., 2009; Botella et al., 2010). Treatment Adherence Treatment adherence was not systematically reported. Three studies reported mean number of modules completed in ICBT and sessions attended in CBT within the treatment period (Bergstrom et al., 2010; Andrews et al., 2011; Spence et al., 2011) and three studies reported both average number of completed modules and sessions and also proportion who completed all modules (Hedam et al., 2011; Hedam et al., 2014; Carlbring et al., 2005). One study reported the number of dropouts (Botella et al., 2010) and one study presented no clear definition of treatment adherence (Andersson et al., 2009) Outcome Informant Two out of eight studies used clinician-rated symptom severity as the primary outcome (Bergstrom et al., 2010; Spence et al., 2011) and the other six, used self-rated measures (Hedman et al., 2011; Hedman et al., 2014; Carlbring et al., 2005; Botella et al., 2010; Andersson et al., 2009; Andrews et al., 2011). Overall Study Quality Involved studies had a total score on the Moncrieff rating scale ranging from 21 to 37 points (M= 33.75, SD= 36). For the total rating, each study see Table 1. One out of eight studies reported a power calculation with full details (study 6), and two studies mentioned power calculation without details. Seven of 8 studies had a specified primary outcome measure (studies 1, 2, 3, 4, 5, 6 and 8). Six of the studies used blind assessors (studies 1, 4, 5, 6, 7 and 8), but testing of blinding was reported in three of them (studies 5, 6 and 8). Half of the trials included a representative sample (for example all consecutive admissions at a clinic against volunteers; (studies 4, 5, 7 and 8). Seven of the studies presented their results from intention to treat-analyses (1, 2, 4, 5, 6, 7 and 8). Meta-Analysis Main findings: ICBT vs. face-to-face treatment All studies A forest plot displaying the effect sizes of studies is presented in figure 2. Through the results, an effect size estimate (g) below 0 favors ICBT while an effect size above 0 represents larger effects for face-to-face CBT. The pooled between-group effect size at post-treatment across all 8 studies was g = .05 (95% CI, −0.16 to 0.18), showing that ICBT and face-to-face treatment produced equivalent overall effects. Two studies (Andersson, 2009; Spence, 2011) were excluded from the meta-analysis because the SD of pre-tests were not reported. The results below are presented separately. Social anxiety disorder The pooled-between group effect size in the three studies targeting social anxiety disorder (Andrews et al., 2011; Hedman, Andersson, et al., 2011; Hedman et al., 2014) was g= .04 (95% CI, −0.19 to 0.27) in line with the notion of equivalent effects. Panic disorder The pooled-between group effect size in the two studies targeting panic disorder (Carlbring et al., 2005; Bergstrom, Andersson et al., 2010) was g= -0.17 (95% CI, −0.48 to 0.14) which represents a non-significant effect in favor of ICBT, however, the sample size in the first study(Carlbring et al., 2005) was small. Fear of public speaking The pooled-between group effect size in one study targeting fear of public speaking(Botella et al., 2010) was g= 0.25 (95% CI, −0.16 to 0.67) in favor of face-to-face treatment, but given the smaller size of the face to face group, the finding was not significantPublication bias Figure 3 displays a funnel plot relating effect sizes on the main outcomes of the studies to the standard errors of the estimates. As shown in figure 3, the effect size was evenly distributed around the averaged effect. The lower left section of the funnel plot includes studies suggesting that there is no major bias of the pooled effect estimate. This is due to small, unpublished studies with results favoring internet treatment. Test of heterogeneity Tests showed significant heterogeneity (????2 = 8.97; I2 = 44%; p = .11) as shown in Table 2. This heterogeneity was largely driven by the study of ICBT vs. face-to-face CBT for panic disorder by Carlbring et al. (2005). If this study was removed from the analysis, I2 dropped from 44 to 27 and heterogeneity would decrease significantly. The pooled effect size across all studies changed marginally from g = .01 (95% CI, −0.16 to .18) to g = −0.06 (95% CI, −0.11 to 0.24) if this study was removed from the analysis.Figure 3. Funnel plot to assess for publication bias by relating effect sizes of the studies to standard errors abbreviation: SMD, the standardized mean difference Conclusions: Discussion This meta-analysis has strong findings and is the first study of anxiety disorders, comparing the internet and face-to-face treatments. The meta-analysis found out that dropouts did not systematically favor one treatment format over the other. Although there were no special effects in favor of either ICBT or face-to-face treatment, there were some fascinating non-significant results in reverse directions, depending on disorders. Most noticeable was the non-significant superiority of internet over the face to face therapy. A possible cause for this is that in one study with g = -0.17 the sample size is face to face group is smaller than the internet group (Andrews et al., 2011) and in another study with g= -0.51 the sample size is small in general (Carlbring et al., 2005). In two studies there were effect sizes in favor of face to face treatment which could be explained by the high effective of the gold standard face to face treatment (Carlbring et al, 2018). The other important difference was that in the treatment of social anxiety disorder, the results were in moderate favor of ICBT (Andrews et al., 2011; Hedman et al., 2014). Probably this non-significant finding can be accepted in light of the possibility that the therapist could be a phobic object itself and the therapeutic relationship would increase the anxiety in these patients. Also, in face-to-face treatment, the patient’s self-focus will be raised and therefore his ability to completely concentrate on the therapy might be prevented (Carlbring et al, 2018). The quality of the studies differed both in terms of accuracy and sample size. However, study quality did not influence outcomes significantly, although the number of studies was too small to conclude that with confidence. Moreover, there was no major bias of the pooled effect estimate. The current meta-analysis had some strong points, including a persistent result across studies concerning the effectiveness of ICBT compared to face-to-face CBT and the reasonably high quality of the trials included. Nevertheless, the study also had limitations. First, there was a possible problem with heterogeneity. Since that was driven by a single extreme value on the panic disorder (Carlbring et al., 2005) that favored ICBT, we decided to report the findings both with and without that study included in the analysis. However, the relative effect of that study on the pooled effect size across all studies was insignificant, with g = .01 changing to g = −.06 if it was excluded. Second, It has been pointed out that internet interventions have high potential for reducing emotional distress, enhancing mental health, and promoting well-being, but there could also be negative impacts related to treatment, though a meta-analysis found that the conditions of 5.8% of participants involved in ICBT worsened (Rozental, Magnusson, Boettcher, Andersson, & Carlbring, 2017). That number compares well with the 5–10% found in face-to-face treatments (Hansen, Lambert, & Forman, 2002) and is much lower than the 17.4% of control group participants in internet-delivered trials (Rozental et al., 2017). In a recent study that investigated the remission rates in ICBT, symptom severity seems to be predictive of outcome inversely, while having more symptoms and being a female increase the chance of improvement (Andersson, Carlbring, Rozental, 2019). Third, the treatment review is based only on CBT, which makes it hard to generalize to other treatment approaches. Whereas the great majority of present treatments are based on cognitive-behavioral platforms, there are other forms of internet-delivered psychotherapy, such as psychodynamic psychotherapy (Johansson et al., 2012), physical exercise (Nyström et al., 2017), and different forms of ICBT, including attention bias modification (Carlbring et al., 2012), problem- solving therapy (Warmerdam, van Straten, Twisk, Riper, & Cuijpers, 2008), and acceptance and commitment therapy (Ivanova et al., 2016). These internet-based intervention programs were not included in the analysis since they generally do not make a direct comparison with face-to-face psychotherapy. Although those clinical approaches are not as popular as CBT in online interventions, since psychodynamic treatment has been found to work in a few trials, it is suggested to study that intervention as well. However for most conditions such as anxiety disorders and health problems they are very few if any other psychotherapy orientations tested and CBT is unchallenged (Andersson, 2014). Fourth, we have compared ICBT to face-to-face therapy regardless of whether it was delivered in an individual or group setting. To resolve the relative efficacy of individual and group settings, head-to-head comparisons need to be conducted (Carlbring et al, 2018). Fifth, we analyzed only the primary outcome measures in the studies (e.g, LSAS: Leibowitz Social Anxiety Scale); we did not include secondary outcomes (e.g, The Spence Children’s Anxiety Scale (SCAS). We cannot, at this point and with the few studies available for each condition, conclude that ICBT and face-to-face therapy are equally effective in all conditions. For example, there are very few studies on gaining knowledge following CBT and even fewer on ICBT (Andersson, Carlbring, Furmark, & on behalf of the SOFIE Research Group, 2012), and the therapy formats may vary in this regard. Moreover, patient characteristics, such as cognitive flexibility (Lindner et al., 2016), have not been considered. This is possibly important since studies are suggesting that different predictors of outcome are relevant when comparing face-to-face treatment vs. Internet treatment (Ebert et al., 2016). Therefore we suggest future reviews to analyze secondary outcomes as well and also consider different variables such as cognitive flexibility in the study. Finally, most of the studies recruited participants only across self-referral or using a combination of self-referral and clinical recruitment. It has been proposed that recruiting through sources that suggest more active treatment-seeking behaviors (e.g. Google searches, viewing postings on mental health websites) leads to participants with more severe anxiety than those recruited through more passive sources of information (Carlbring et al., 2018). So It is suggested for future research to recruit through the digital footprint of users all over the world to find out who is seeking therapy. The results of our meta-analysis are interesting both from theoretical and practical standpoints. In terms of theories about change in psychotherapeutic interventions, the findings suggest that the role of a face-to-face therapist may not be as essential as suggested in the previous literature for producing large treatment effects (Wampold, 2001). Even if factors such as therapeutic alliance are established in guided ICBT, they are hardly important for its outcome (Andersson, paxling, et al, 2012). Indeed, understanding what makes ICBT work is a challenge for future research as only a few studies to date have examined mediators of outcome (e.g. Hedman et al., 2013; Hesser, Westin, & Andersson, 2014; Karyotaki et al., 2015). In conclusion, the purpose of this systematic review and meta-analysis was to collect and analyze studies in which ICBT had been directly compared with face-to-face CBT. The results show that two treatment formats are equally effective in treating social anxiety disorder, adolescent anxiety, panic disorder, spider phobia and fear of public speaking. Clinical Trial: The authors declare no conflict of interest. This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors

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