Health TrialsbyHealthPanel

Couples' Affect in Relationships Study

ConditionDepression Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • List of well-being resources

    Behavioral

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

Treatment groups

2,000 Participants
are divided into 3 treatment groups
Group A: The Healthy Minds Program (HMP) mobile applicationExperimental treatment 1 intervention
Group B: List of well-being resourcesExperimental treatment 1 intervention
Group C: Partner - Surveys onlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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

Change in Second-Person PHQ-9 Rating of Primary Participant

Second-Person PHQ-9 as assessed by the partner participant. PHQ-9 is a 9 item survey about how often in the past 2 weeks their partner 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.

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

Secondary outcomes

1

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

SOCS-S is a 20 item survey asking how the participant relates to themself. It is scored on a 5-point Likert scale, where 1 = not at all true and 5 = always true. Scores range from 20-100, with higher scores indicating greater self-compassion.

Time frame
Baseline, Week 4, 3-Month Follow-Up
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.

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

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

A measure of feelings of depression scored from 1 to 5 where higher numbers indicate increased feelings of depression. Full range of scores is 28-140.

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

Change in Second-Person PHQ-9 Rating of Primary Participant

Second-person PHQ-9 as assessed by the primary participant. PHQ-9 is a 9 item survey about how often in the past 2 weeks their partner 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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Wisconsin, Madison

Lead sponsor

Source ClinicalTrials.gov
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