Integrated Depression Care and Livelihood Interventions for Low-Income Women in Vietnam: Protocol for a Cluster Nonrandomized Controlled Trial (LIFE-DM).

Background: In Vietnam, economically disadvantaged women face compounded risks due to gender inequality, financial instability, and limited access to mental health care. Community health stations (CHSs), the frontline entry point into the health system and the most accessible primary care facilities, typically lack trained mental health providers, further exacerbating an already existing treatment gap. While evidence-based treatments for depression exist, most interventions address either mental health or economic hardship separately, limiting their effectiveness in resource-constrained settings. Objective: This study aims to evaluate the effectiveness of Livelihood Integration for Effective Depression Management (LIFE-DM), an integrated intervention combining group-based psychotherapy with microfinance and livelihood support, compared with enhanced treatment as usual (E-TAU), among low-income women. We hypothesize that LIFE-DM participants will show greater program participation and improvements in mental health, psychosocial, and economic outcomes relative to E-TAU. Methods: A matched-pair cluster nonrandomized controlled trial was conducted at 4 CHSs in Da Nang, Vietnam, with 2 sites allocated to LIFE-DM and 2 to E-TAU. A total of 166 low-income women aged 18 to 55 years who screened positive for depression (9-item Patient Health Questionnaire score ≥10) were enrolled. LIFE-DM participants received group behavioral activation treatment and were offered microfinance loans, vocational training, and personal finance support. E-TAU participants were offered free antidepressant treatment and referral as usual to the Women's Union for livelihood support. Primary outcomes are severity of depression symptoms and remission rates at 6- and 12-month follow-up. Secondary outcomes include economic variables such as income and employment status, as well as functioning, quality of life, self-efficacy, behavior activation, and program participation. The data were collected using in-person surveys, clinic logs, and program records. Analyses will follow an intention-to-treat approach using longitudinal regression models with propensity score weighting and adjustment for clustering. Results: This study was funded prior to implementation, and the data were collected from February 2014 to September 2015. Participant recruitment has been completed, with 166 women enrolled across 4 CHSs. Data analysis is in progress, and the findings are expected to be disseminated in 2027. Conclusions: This study is among the first to rigorously evaluate an integrated mental health and livelihood intervention targeting both depression and poverty among economically disadvantaged women. If effective, LIFE-DM may offer a scalable, community-based model for improving mental health and economic well-being among vulnerable women in low-resource settings.