Couples' Affect in Relationships Study

NCT06907654 | Not Yet Recruiting FDA Device

• 3 other identifiers: 2025-0357A171600EDUC/COUNSELING PSYCH
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to find out whether learning about well-being impacts the thoughts and feelings of romantic couples. The main question it aims to answer is:

• Does gaining knowledge about well-being positively impact individuals and their romantic relationships? Participants will complete online surveys about their thoughts and feelings.

Conditions

Depression Disorders

Keywords

romantic relationship; long-term relationship

Outcome Measures

Primary Outcomes (2)

• Change in Primary Participant-Rated PHQ-9

  PHQ-9 is a 9 item questionnaire where participants report how often in the past 2 weeks they were bothered by specific problems. It is scored on a 4-point Likert scale, where 0=not at all and 4=nearly every day. Scores range from 0-36, where higher scores indicate more depressive symptoms.

  Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up

• Change in Primary Participant-Rated Couples Satisfaction Index (CSI-16)

  CSI-16 scores can range from 0 to 81. Higher scores indicate higher levels of relationship satisfaction. CSI-16 scores falling below 51.5 suggest notable relationship dissatisfaction.

  Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up

Secondary Outcomes (20)

• Change in Sussex-Oxford Compassion for the Self Scale (SOCS-S)

  Baseline, Week 4, 3-Month Follow-Up

• Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression

  Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up

• Relationship Longevity

  Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up

• Change in Partner Participant-Rated PHQ-9

  Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up

• Change in Problematic and Risky Internet Use Screening Scale (PRIUSS 3)

  Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up

Study Arms (3)

The Healthy Minds Program (HMP) mobile application

EXPERIMENTAL

Primary participants in the HMP group will be instructed to complete a 4-week intervention through the app.

Device: well-being app

List of well-being resources

EXPERIMENTAL

Primary participants will be instructed to use a curated list of well-being resources.

Behavioral: List of well-being resources

Partner - Surveys only

NO INTERVENTION

Partner participants will complete surveys their thoughts and feelings.

Interventions

well-being app DEVICE

The HMP app is a meditation-based smartphone app designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of guided practices. HMP has guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.

The Healthy Minds Program (HMP) mobile application

List of well-being resources BEHAVIORAL

Participants will be given a list of resources that promote well-being.

List of well-being resources

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Be either married, living together, OR in a dating relationship for at least 12 months
• Proficiency in English
• US citizen or permanent resident
• If non-monogamous, must be able to enroll in the study with a primary partner with whom they spend the majority of their time.
• Use of a smartphone (primary participant only)
• Depression symptoms (≥ 5 on PHQ-9; primary participant only)

You may not qualify if:

• Severe physical or sexual relationship aggression during the past 6 months (any item endorsement on 5-item severe IPV screener)
• Endorsement of active suicidality
• History of psychosis or mania
• Prior use of the Healthy Minds Program app
• Prior significant experience with meditation
• Severe hearing impairment that would interfere with the use of an audio-based intervention (primary participant only)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Simon Goldberg, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lily Smith

CONTACT

cares@chm.wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 2, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)