Globally, depression is one of the biggest contributors to the mental health burden of disease. The relationship between poverty and depression is well-documented. Depression substantially impairs social functioning and is associated with reduced workforce participation, thereby contributing to poverty. At the same time, poverty is an important social determinant of depression. People living in poverty execute low-skilled work, find themselves in insecure job situations, and face volatile incomes. This financial insecurity increases stress, which can lead to depression. This negative cycle between poverty and depression is of particular importance in India, where governmental financial risk protection measures are lacking and baseline poverty is high. Reduced income resulting from depression associated disability or unemployment and high out-of-pocket health care expenditures place people with depression at risk for impoverishment. Therefore, intersectoral programs that combine economic empowerment with evidence-based interventions for depression not only provide a great opportunity to treat severe depression in resource-limited settings through linking mental health delivery to rural development schemes, but also increase access to mental health care through a different route of delivery.

The THRIVE trial(Transformative Health & Recovery Initiative through Valuable Economic aid) is designed to assess the effectiveness and economic benefits of a cash-plus program to treat adults with severe depression in rural India. Our primary hypothesis is that the cash-plus program, that is, unconditional cash transfers plus enhanced usual care, will be superior in reducing depression at six months as compared to enhanced usual care. Enhanced usual care consists of a brief psychological intervention and antidepressants in case of non-response to psychological treatment. Other objectives include the evaluation of the effect of the cash-plus program on functional, social, and economic outcomes, a return on investment analysis to determine overall economic benefits from a societal perspective, and the exploration of mechanisms of action of cash transfers using mediation analysis and qualitative research.

A cluster randomised controlled superiority trial with 1 to 1 allocation of primary health care centres (clusters) to either the cash-plus program or enhanced usual care will be conducted. We will recruit 670 adults with severe depression (Patient Health Questionnaire [PHQ-9] Score equal to and greater than 15) from 20 primary health care centres (clusters) each in the Uttara Kannada district of Karnataka and the Arvalli district in Gujarat, northwest India. The cash-plus program consists of monthly unconditional cash transfers (5,000 INR per month) over six months and two sessions on financial management skills, plus the Healthy Activity Program (HAP) – a culturally-sensitive and evidence-based brief psychological intervention delivered by lay health workers (LHWs) alongside usual care. Usual care at the primary care level in India typically consists of antidepressants such as Fluoxetine, Sertraline, and Amitriptyline as essential medicines prescribed by general practitioners. The control group will receive enhanced usual care consisting of the HAP and antidepressants as needed. The LHWs delivering the HAP will be randomly allocated to the primary health care centres. They will not be included in any other aspects of the THRIVE trial.