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Mental HealthNCT07108049

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

A study testing Let us Grow Together: Economic Wellbeing for Families in people with Mental Health and Empathy, run by Technical University of Munich at 2 sites in India.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health, Empathy, Relation, Interpersonal
What is being tested?
Let us Grow Together: Economic Wellbeing for Families
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,552 participants
Where
2 sitesIndia
Study dates
29 Jul 2025to Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

2 sites in 1 country.

India2 sites

  • 50 clusters across Maharashtra, Andhra Pradesh and Rajasthan

    Mumbai, Maharashtra

  • Vayam Organisation

    Noida

Other trials in India

About this study

Official title: A Randomized Controlled Trial of a Couple-Based Economic Empowerment Intervention to Improve Relationship Quality and Mental Health in Three States of India

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.

Read more

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.

Read the detailed description

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.

Being tested
Let us Grow Together: Economic Wellbeing for Families
Keywords
Couples Intervention, Economic Empowerment, Gender Transformation, Mental Health, GHQ-6, Cluster RCT, India, Family Economic Wellbeing, Couple-based Empathy, Relationship Satisfaction, Relationship Quality
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Let us Grow Together: Economic Wellbeing for FamiliesBehavioural

    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 e

Study groups in NCT07108049
Study groupRoleWhat they receive
Let's Grow Together InterventionExperimentalMarried 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
Receives: Behavioral: Let us Grow Together: Economic Wellbeing for Families
No Structured SupportNo interventionMarried 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Psychological Distress Score on the Response-Adapted GHQ-6 (General Health Questionnaire)

    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.

    Measured: T2 = endline, approximately 6 months after intervention delivery and approximately 1 year after baseline (prior to session 1)

Secondary outcomes (1)

  1. Mean Relationship-Quality Composite Score at Endline

    Relationship quality at endline is measured as the mean of standardised scores from two 3-item scales: Relationship Satisfaction and Relationship Empathy. Higher scores indicate higher relationship quality. Relationship Satisfaction is adapted from the Quality of Marriage Index and assesses marital strength, happiness, and teamwork. Relationship Empathy is adapted from the Interpersonal Reactivity Index for Couples. Because the two components were highly correlated at baseline, they are combined into a single relationship-quality composite to reduce multiplicity. The treatment effect will be estimated by comparing endline composite scores between randomised groups while adjusting for baseline relationship quality and prespecified baseline covariates. Treatment effects on each component will be reported in supplementary analyses.

    Hypothesis: greater improvement in relationship quality in the intervention group.

    Measured: T2 = endline, approximately 6 months after intervention delivery and approximately 1 year after baseline (prior to session 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2025
  2. Study start29 Jul 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4,552 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07108049
Sponsor's protocol ID
TUM-EcoVi-01
Other IDs
ECOVI, 101115963
Status last verified
Sep 2026
First submitted
25 Jul 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) will not be shared. However, fully anonymized datasets may be shared with project partners and qualified researchers working on related topics (e.g., mental health and economic violence) for secondary analyses, including cross-country or pooled analyses, subject to data sharing agreements and ethical approvals. Timeframe: Anonymized data may be shared beginning in 2026, following primary publications. Access Criteria: Available on request upon approval by overall study PI Prof. Dr. Steinert

Publications

  • Falconier, M. K., Kim, J., & Lachowicz, M. J. (2023). Together-A couples' program integrating relationship and financial education: A randomized controlled trial. Journal of Social and Personal Relationships, 40(1), 333-359. https://doi.org/10.1177/02654075221118816

  • Funk JL, Rogge RD. Testing the ruler with item response theory: increasing precision of measurement for relationship satisfaction with the Couples Satisfaction Index. J Fam Psychol. 2007 Dec;21(4):572-83. doi: 10.1037/0893-3200.21.4.572.

    PubMed 18179329

  • Imai K, Keele L, Tingley D. A general approach to causal mediation analysis. Psychol Methods. 2010 Dec;15(4):309-34. doi: 10.1037/a0020761.

    PubMed 20954780

  • Ismayilova L, Karimli L, Gaveras E, To-Camier A, Sanson J, Chaffin J, Nanema R. An Integrated Approach to Increasing Women's Empowerment and Reducing Domestic Violence: Results of a Cluster-Randomized Controlled Trial in a West African Country. Psychol Violence. 2018 Jul;8(4):448-459. doi: 10.1037/vio0000136. Epub 2017 Aug 7.

    PubMed 34790432

  • John NA, Adebayo A, Boychuk NA, OlaOlorun F. Intimate partner violence (IPV) prevention using a cross-sectoral couple-based intervention: results from a cluster randomised control trial in Ibadan, Nigeria. BMJ Glob Health. 2022 Feb;7(2):e007192. doi: 10.1136/bmjgh-2021-007192.

    PubMed 35140139

  • Kim JC, Watts CH, Hargreaves JR, Ndhlovu LX, Phetla G, Morison LA, Busza J, Porter JD, Pronyk P. Understanding the impact of a microfinance-based intervention on women's empowerment and the reduction of intimate partner violence in South Africa. Am J Public Health. 2007 Oct;97(10):1794-802. doi: 10.2105/AJPH.2006.095521. Epub 2007 Aug 29.

    PubMed 17761566

  • Moore, Q., Wood, R. G., & Wu, A. Y. (2023). Impacts of healthy marriage and relationship education with integrated economic stability services. Family Relations, 72(4), 1422-1440. https://doi.org/10.1111/fare.12877

  • Peloquin K, Lafontaine MF. Measuring empathy in couples: validity and reliability of the Interpersonal Reactivity Index for couples. J Pers Assess. 2010 Mar;92(2):146-57. doi: 10.1080/00223890903510399.

    PubMed 20155564

  • Raj A, Ghule M, Johns NE, Battala M, Begum S, Dixit A, Vaida F, Saggurti N, Silverman JG, Averbach S. Evaluation of a gender synchronized family planning intervention for married couples in rural India: The CHARM2 cluster randomized control trial. EClinicalMedicine. 2022 Mar 5;45:101334. doi: 10.1016/j.eclinm.2022.101334. eCollection 2022 Mar.

    PubMed 35274093

  • Rao KN, Begum S, Siddappa K, Ravindra K. Validity of a 6-item version of general health questionnaire (g.h.q.) in the hands of a non - psychiatrist. Indian J Psychiatry. 1992 Apr;34(2):145-7.

    PubMed 21776115

Questions about this trial

What is this clinical trial studying?

A study testing Let us Grow Together: Economic Wellbeing for Families in people with Mental Health and Empathy, run by Technical University of Munich at 2 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Psychological Distress Score on the Response-Adapted GHQ-6 (General Health Questionnaire) (time frame: T2 = endline, approximately 6 months after intervention delivery and approximately 1 year after baseline (prior to session 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07108049, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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