Clinical trial NCT06907654: Couples' Affect in Relationships Study
Official title: Couples' Affect in Relationships Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression Disorders
Keywords: romantic relationship
long-term relationship
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This study will deliver a meditation-based mobile intervention (The Healthy Minds Program) to one member of a long-term romantic couple and will assess for relationship satisfaction/distress, well-being, and mindfulness in both the primary participant and their partner. The control group will receive a list of well-being-based psychoeducation resources.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Composite of Patient-Reported Outcomes Measurement Information System (PROMIS) Depression
timeFrame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
measure: Change in Second-Person PHQ-9
timeFrame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
measure: Change in PHQ-9
timeFrame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
measure: Change in Couples Satisfaction Index (CSI-16)
timeFrame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
Secondary outcomes:
measure: Change in Sussex-Oxford Compassion for the Self Scale (SOCS-S)
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Relationship Longevity
timeFrame: Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
measure: Change in Problematic and Risky Internet Use Screening Scale (PRIUSS 3)
timeFrame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
measure: Change in Second-Person Sussex-Oxford Compassion for the Self Scale (SOCS-S)
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Relationship Attribution Measure
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Partner Acceptance Scale
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Observed Mindfulness Measure
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Loneliness Measured by NIH Toolbox Loneliness Score
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
timeFrame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2 Year Follow-Up
measure: Change in Healthy Minds (HM) Index
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in the Mindful Attention Awareness Scale (MAAS)
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Conflict Resolution Scale
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Digital Working Alliance Inventory
timeFrame: Week 4, 3-Month Follow-Up
measure: Change in Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Cannabis Use Disorders Identification Test - Revised (CUDIT-R)
timeFrame: Baseline, Week 4, 3-Month Follow-Up
measure: Change in Mild-to-moderate IPV Questionnaire
timeFrame: Baseline, Week 4, 3-Month Follow-Up
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin - Madison
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Simon Goldberg, PhD
role: PRINCIPAL_INVESTIGATOR
References: