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Strengthening Relationships and Mental Health Through a Couples-Based Economic Empowerment Intervention

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints removed 3 → 1 primary endpoints
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Record History

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  1. Notable Primary endpoint(s) modified Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Enrollment target: estimated 4500 to confirmed 4552
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints expanded, about 6 words
    • Study description shortened, about 383 words
    • Site details revised at 2 of 2 sites
    • Publications: details revised at 9 of 10 entries
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This psychosocial sub-study is embedded within a larger cluster-randomised controlled trial titled Disentangling and Preventing Economic Violence against Women (ECOVI), conducted in rural and urban communities across Maharashtra, Andhra Pradesh, and Rajasthan, India. The sub-study evaluates the effects of a couples-based financial-literacy and gender-transformative intervention on psychological distress and relationship quality among married couples. A total of 150 clusters were randomised in a 1:1 ratio to the intervention or control condition by an external trial statistician. Approximately 15 husband-wife pairs were enrolled per cluster, resulting in 2,276 couples at baseline. Participants in intervention clusters attend six structured, community-based sessions that combine financial literacy content with gender equity, communication, empathy, and shared decision-making activities. Participants in control clusters receive no structured study intervention. Assessments are conducted at baseline, before the first intervention session, and at endline, approximately 6 months after intervention delivery. The primary outcome is psychological distress at endline, measured using a response-adapted 6-item General Health Questionnaire. The secondary outcome is relationship quality at endline, measured using a composite of relationship satisfaction and relationship empathy. Treatment effects will be estimated using models that adjust for the corresponding baseline outcome and state. Exploratory mediation analyses will assess whether the intervention's effect on psychological distress is statistically consistent with indirect pathways operating through relationship quality and economic stress.
Trial Details
NCT Number NCT07108049
Lead Sponsor Technical University of Munich
Collaborators: European Research Council
Conditions
(from sponsor)
Mental Health, Empathy, Relation, Interpersonal
Related terms Psychological Well-Being
Enrollment 4,552 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov