Mental disorders are among the top 10 leading causes of global disease burden [1]. Depression is the most common mental disorder and is twice as common in women than in men [2]. Women in general experience several sources of stress such as being the sole childrearing adult in a household, managing multiple roles, unequal power relations with men, a sense of powerlessness [3], and higher rates of poverty [4], all of which are associated with a higher risk of depression.

Women with depression, even of mild to moderate severity, experience high rates of morbidity, functional impairment, low quality of life [5], and higher risk of suicide [6]. The effects of depression in women impact families as well given the multidimensional roles that they play [7]. Yet, depression often goes undiagnosed and untreated in women in India due to stigma, childcare, gender inequality, and mental health workforce deficits, impacting mental health treatment access [8]. Only one woman attends an outpatient mental health appointment for every three men in India [8], and untreated depression among women is a major public health problem. While digital mental health solutions can help close this treatment gap, there is a need to adapt these digital mental health solutions to the context and to specific users. For example, while app-based depression screening and treatments are widely used and effective, issues such as shared ownership of phones, which is very common in India [9], may pose a barrier to the widespread use of digital mental health solutions. In general, access to mobile phones is lower among women in India, especially in rural India, as women have time allocation constraints on phone usage, limited digital skills, and often depend on men for phone ownership [10,11].

Given these contextual considerations, we used a participatory design to develop and test an app—Multiuser Interactive Health Response Application (MITHRA)—that screens for depression and provides a brief behavioral intervention [12]. This is a multiuser app deployed in self-help groups (SHGs), which are community-based organizations for women. The conceptual model for MITHRA is based on Fortney et al’s [13] access to care model, and MITHRA targets actual and perceived barriers to access identified by patients. MITHRA uses nonencounter-based screening, tracking, and low-intensity interventions, addressing the barriers of stigma and travel time. MITHRA addresses the perceived need for care among women by providing education about depression. The process of app development has been described previously [14]. Briefly, women are presented with multimedia modules to view based on their Patient Health Questionnaire-9 (PHQ-9) score. Women who score <5 receive a prompt to watch general information on depression; women who score 5 or higher watch short (10 to 15 min) interactive multimedia-based modules based on the Healthy Activity Program [15], a brief behavioral intervention.

Here, we describe a pilot randomized controlled trial (RCT) designed to test the feasibility, acceptability, and preliminary effectiveness of MITHRA in improving depression outcomes.

The flowchart showing participant inclusion is shown in Figure 1.

This study demonstrates the feasibility and acceptability of deploying a culturally tailored app-based depression intervention (MITHRA) within women’s SHGs in rural India. MITHRA is designed to address the large treatment gap for depression in women. It was developed in consultation with key end-users, it is culturally appropriate (settings and characters in the video reflect the users), available in the local language, and based on an evidence-based intervention.

We successfully completed a pilot cluster RCT comparing MITHRA to EUC to assess the feasibility of recruitment and randomization, acceptability, and preliminary effectiveness. In this RCT, we randomized participants to app-based depression screening and treatment in community-based settings. Participants in the control arm received EUC; they viewed one module of education on the symptoms of depression and how to seek help. Typical or usual care in SHGs includes no screening or education regarding depression. We found that it is feasible to recruit and randomize SHGs to app-based treatment or usual care, and to obtain consent from SHG members to participate in a clinical trial. Our pilot cluster RCT adds to a small but growing body of evidence supporting the use of digital mental health interventions for women in low-resource settings, particularly in South Asia, where access to mental health care remains limited. For example, a similar study in a low- or middle-income country highlights the high acceptability of mobile-based interventions among women with limited access to traditional mental health services [18].

Randomization was not balanced for patient-level characteristics such as socioeconomic status and depression, a limitation that can occur in cluster RCTs [19]. We controlled for these characteristics in our analysis. We had an excellent retention rate of 92% at both the time-points of 3 months and 6 months. Women in the intervention arm engaged well with the app, with 96% of the women completing at least 50% of the modules assigned to them. This suggests that carefully designed locally contextualized digital tools can be both feasible and acceptable in these settings. We also demonstrated the feasibility of collecting the required data and conducting analyses.

Preliminary analyses showed that symptom scores as measured by the PHQ-9 and QIDS scales decreased over time in women assigned to MITHRA compared to EUC. Our post-hoc analysis showed that in MITHRA SHGs, the proportion of women with mild-to-moderate depression symptoms as measured using the PHQ-9 was significantly lower at 6 months compared to that at baseline. This proportion did not reach statistical significance in the EUC arm. While the study was not powered to detect efficacy, these signals are promising and aligned with broader evidence, indicating that even lower-intensity digital psychological interventions can lead to meaningful improvements in mental health outcomes.

Our findings also contribute to the growing literature on stepped care approaches for depression in low- or middle-income countries. MITHRA incorporates the core principles of stepped care by providing low-intensity scalable interventions for women with mild-to-moderate symptoms while also including protocols for referral or treatment intensification for those with severe symptoms. Although no women in our study met the criteria for severe depression or required stepped-up care, the infrastructure we established for monitoring and referral are aligned with best practices to allocate resources efficiently while ensuring that individuals receive appropriate levels of care. The absence of referrals in our sample may reflect the fact that women with more severe depressive symptoms are less likely to participate in SHGs, an important gap that future work must address. Similarly, no women in the study endorsed suicidal ideation; however, we did have appropriate treatment intensification protocols in place as part of the stepped care.

The limitations of our study include that our results may not be applicable to women with severe depressive symptoms who may not be attending SHG meetings. Additionally, as a feasibility study, our primary objective was to assess feasibility and acceptability, and we were not powered to assess effectiveness. The preliminary data generated will inform the design of a fully-powered RCT. In addition, the study was funded in 2020, and India was in a national lockdown for 2 months in early 2020 due to the COVID-19 pandemic. This delayed the study onset, as community gatherings were not allowed.

We found that it is feasible to conduct a pilot RCT of an app-based depression screening and brief behavioral intervention in community-based organizations in rural India. App-based depression screening and treatment such as that offered by MITHRA can help address barriers to mental health treatment access such as transportation and mental health workforce deficits. Deploying MITHRA in women’s SHGs can also help address gender-specific stigma and access to treatment. Widespread implementation of community-based solutions such as MITHRA that focus on the prevention of depression onset or treatment of mild-to-moderate symptoms should always be coupled with a plan to intensify care as needed for those with severe symptoms. The next steps are to test the effectiveness of this approach in the treatment of depression in women in a larger RCT.