A Randomized Controlled Trial of a Couple-Based Economic Empowerment Intervention to Improve Relationship Quality and Mental Health in Three States of India
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,552
- 试验地点
- 4
- 主要终点
- Mean Psychological Distress Score on the Response-Adapted GHQ-6 (General Health Questionnaire)
研究概览
简要总结
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.
详细描述
Economic hardship can affect both psychological well-being and relationship functioning within couples. Programs combining economic-strengthening activities with gender-transformative and relationship-focused content may improve communication, shared decision-making, relationship quality, and psychological well-being. However, evidence concerning psychosocial outcomes and the pathways through which these programs may affect mental health remains limited.
This psychosocial sub-study is embedded within the broader "Let Us Grow Together: Economic Wellbeing for Families" intervention. The intervention combines financial-literacy training with gender-transformative content addressing communication, empathy, shared decision-making, and other intra-household relationship dynamics. The sub-study evaluates the intervention's effects on psychological distress and relationship quality among participating husbands and wives.
Exploratory mediation analyses will assess whether the intervention's effect on psychological distress is statistically consistent with indirect pathways operating through relationship quality and household economic stress. Exploratory moderation analyses will assess whether effects on psychological distress vary according to baseline economic stress, baseline psychological distress, and state. These analyses will be interpreted as hypothesis-generating.
In July 2026, before endline data collection and before any examination of endline outcomes, the outcome and analysis plans were refined following a methodological review and analyses of pooled baseline and pre-treatment data. Psychological distress was designated as the primary outcome, and the relationship-quality composite as the secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Let's Grow Together Intervention
Married couples in clusters assigned to the intervention receive a structured program of six community-based sessions. Each session lasts between 2.5 and 3 hours and includes participatory activities, discussions, and exercises. All six sessions would be conducted by the same two facilitators - one male and one female. The content integrates financial literacy (e.g., household budgeting, saving practices, joint financial planning) with gender-transformative training (e.g., equitable household roles, communication skills, conflict resolution, and fostering empathy between spouses). Sessions are delivered by trained facilitators in a group setting with fifteen couples, approximately every 2-4 weeks. Some sensitive content to address economic violence context would be done in a gender segregated manner separately to encourage reflections, ensure safety and reduce defensiveness. Between sessions, SMS reminders and tips are sent to participants' mobile phones to reinforce key messages and
干预措施: Let us Grow Together: Economic Wellbeing for Families (Behavioral)
No Structured Support
Married couples in clusters assigned to the control arm do not receive the special couples training during the study period. Participants in control group continue with standard activities and resources available in the community but without the structured sessions provided to the intervention arm. This control condition represents the status quo against which the added effect of the intervention can be measured. After the conclusion of the study, control clusters may be offered the intervention materials or sessions via the NGO partners in case investigators find overall positive treatment effects, ensuring ethical considerations are met.
结局指标
主要结局
Mean Psychological Distress Score on the Response-Adapted GHQ-6 (General Health Questionnaire)
时间窗: T2 = endline, approximately 6 months after intervention delivery and approximately 1 year after baseline (prior to session 1)
Psychological distress at endline is measured with a response-adapted 6-item General Health Questionnaire. The original symptom content was retained, and the response format was adapted after piloting to a 5-point scale from 1 = not at all to 5 = much more than usual. Positively worded items are reverse-coded so that higher scores indicate greater distress. Because the response format is adapted, standard GHQ caseness thresholds do not apply. Scores are analysed as a continuous mean score, requiring at least 4 of 6 valid items. The treatment effect will be estimated by comparing endline scores between randomised groups while adjusting for baseline GHQ-6 and prespecified baseline covariates. A prespecified sensitivity analysis will repeat the model using a 5-item composite excluding the item with poor baseline item-total performance. Hypothesis: greater distress reduction in the intervention group.
Mental Health Scale (General Health Questionnaire - 6)
时间窗: T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))
Change in General Health Questionnaire-6 scores (psychological distress). It is scored on a scale of 0-4, where higher score indicates higher psychological distress. Hypothesis: Greater distress reduction (or well-being increase) in the intervention group.
Perceived Relationship Strength (PRS)
时间窗: T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))
Change in the composite Relationship Satisfaction Index (adapted for study); looking at trust, communication, mutual support, conflict resolution. The scale is scored on 1-5 scale, with higher score indicating higher perceived relationship score. Hypothesis: Greater improvement in the intervention group than in controls.
Relational Empathy Scale (RE)
时间窗: T1 = baseline (prior to session 1); T2 = endline (~6 months after intervention, approx. 1.5 years after baseline))
Adapted standardized Interpersonal Reactivity Index for Couples (emotional support, perspective-taking). The scale is scored on 1-5 scale, with higher score indicating higher empathy in relationship score. Hypothesis: Larger empathy gains in the intervention group.
次要结局
- Mean Relationship-Quality Composite Score at Endline(T2 = endline, approximately 6 months after intervention delivery and approximately 1 year after baseline (prior to session 1))
研究者
Anushree Dirangane
PhD Researcher
Technical University of Munich