Abstract
BACKGROUND: Depression in women results in elevated morbidity rates, functional impairment, diminished quality of life, and an increased risk of suicide. Numerous obstacles impede access to mental health treatment for women in India. Digital mental health solutions can bridge the treatment gap, but it is important to tailor these solutions to the context and to end-users. OBJECTIVE: We conducted a pilot randomized controlled trial to test the feasibility, acceptability, and preliminary effectiveness of a mental health app deployed in community-based organizations in improving depression outcomes. METHODS: The Multiuser Interactive Health Response Application (MITHRA) is a multiple-user mobile app used in community-based organizations for screening, tracking, and supporting stepped-care treatment for depression. MITHRA is based on the healthy activity program, a brief psychological intervention based on behavioral activation. It includes audio, video, and enhanced touchscreen capabilities to overcome the barrier of illiteracy and lack of access. It was developed in collaboration with a participatory design group consisting of primary and secondary end-users and is available on tablets installed in self-help groups (SHGs), which are community-based organizations in India. The SHGs were randomized to MITHRA (n=3) or enhanced usual care (EUC; n=3). During SHG meetings, women completed the Patient Health Questionnaire-9 (PHQ-9). Based on their PHQ-9 scores, they were assigned different modules. In the EUC SHGs, women viewed one module of education on symptoms of depression. Primary outcomes include feasibility and acceptability, and secondary outcomes include depressive symptoms and functioning. Repeated-measures ANOVA was performed to compare the change in the outcome scores over time between study groups. A P value of<.05 was considered statistically significant. RESULTS: MITHRA was found to be feasible and acceptable. A total of 96% of intervention arm participants completed at least half of their assigned modules. Although not powered for effectiveness outcomes, in this trial, we found that the change at 6 months from baseline in depressive symptoms (PHQ-9) were significantly different between MITHRA and EUC (P=.037), with greater improvement in the intervention group. Similarly, significant improvement in the World Health Organization Disability Assessment Scale score was noted in the MITHRA group (P=.005). CONCLUSIONS: MITHRA is feasible and acceptable for use in women's SHGs. Larger studies should examine the effectiveness of this approach in identifying and treating depression.