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Recruiting NCT06907654

Couples' Affect in Relationships Study

No phase Interventional Depression Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: well-being app, List of well-being resources.
Who it may be relevant to
Registry conditions: Depression Disorders. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Device well-being app
    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.
  • Behavioral List of well-being resources
    Participants will be given a list of resources that promote well-being.

Primary outcome measures

  • Change in Primary Participant-Rated Couples Satisfaction Index (CSI-16) [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Second-Person PHQ-9 Rating of Primary Participant [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
Secondary outcome measures (12)
  • Change in Sussex-Oxford Compassion for the Self Scale (SOCS-S) [Time frame: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Primary Participant-Rated PHQ-9 [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depression [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Second-Person PHQ-9 Rating of Primary Participant [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Relationship Longevity [Time frame: Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Partner Participant-Rated PHQ-9 [Time frame: 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) [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Partner Participant-Rated Couples Satisfaction Index (CSI-16) [Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up]
  • Change in Second-Person Sussex-Oxford Compassion for the Self Scale (SOCS-S) [Time frame: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Relationship Attribution Measure [Time frame: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Partner Acceptance Scale [Time frame: Baseline, Week 4, 3-Month Follow-Up]
  • Change in Observed Mindfulness Measure [Time frame: Baseline, Week 4, 3-Month Follow-Up]

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)
  • Phone able to receive SMS text messages
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Wisconsin - Madison — Madison

Identifiers

NCT: NCT06907654 · 2025-0357 · A171600 · EDUC/COUNSELING PSYCH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗