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Active Not Recruiting NCT07108049

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

Conditions: Mental Health, Empathy, Relation, Interpersonal

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 4552
Sponsor: Technical University of Munich

Location: 50 clusters across Maharashtra, Andhra Pradesh and Rajasthan Mumbai Maharashtra

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Women: 18 - 49 years, Men: 18+ * Couples: Married and co-habitating, husband-wife pairs, who regard the selected cluster in the states Maharashtra, Andhra Pradesh, or Rajasthan of India as their primary residence for the study period. * Consent: Both partners provide written informed consent and agree to six sessions, baseline and endline surveys, and SMS follow-ups. * Education: Primary schooling (4th grade) complete * Comprehension: Both partners understand the local language used in sessions. * Availability: No plans for relocation or prolonged absence before endline. Exclusion Criteria: * Either partner \< 18 years * Refusal of consent or unwillingness to participate in sessions or data collection by either partner. * Serious physical or mental condition that prevents safe, active participation (e.g., severe mental illness, debilitating disease).

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07108049). StuddyBuddy aggregates publicly available trial information.