Couples' Affect in Relationships Study (Cares)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Depression Disorders
• Intervention / Treatment: Device: well-being app; Behavioral: List of well-being resources

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.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lily Smith; Email: cares@chm.wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin - Madison
      • Principal Investigator: Simon Goldberg, PhD
      • Contact: Lily Smith; Email: cares@chm.wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The Healthy Minds Program (HMP) mobile application; Primary participants in the HMP group will be instructed to complete a 4-week intervention through the app.	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.
Experimental: List of well-being resources; Primary participants will be instructed to use a curated list of well-being resources.	Behavioral: List of well-being resources; Participants will be given a list of resources that promote well-being.
No Intervention: Partner - Surveys only; Partner participants will complete surveys their thoughts and feelings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Second-Person PHQ-9	PHQ-9 as assessed by the partner. 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.	Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
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.	Baseline, Week 4, 3-Month Follow-Up
Relationship Longevity	The relationship longevity questionnaire asks participants about their relationship status at the end of study participation.	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)	PRIUSS 3 is a 3 item questionnaire regarding internet use. It is scored on a 4-point Likert scale where 0=never and 4=very often. Total scores range from 0-12 with higher scores indicating greater problems with internet use.	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)	SOCS-S is a 20 item survey about how your partner might relate 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.	Baseline, Week 4, 3-Month Follow-Up
Change in Relationship Attribution Measure	The relationship attribution measure is a 6 item survey about critical behavior the participant's partner might do. It is scored on a 6-point Likert scale, where 1 = disagree strongly and 6 = agree strongly. Scores range from 6-36, with higher scores indicating greater dissatisfaction with their partner's criticism.	Baseline, Week 4, 3-Month Follow-Up
Change in Partner Acceptance Scale	The Partner Acceptance Scale is a 5-item scale measuring to what extent the respondent acknowledges his/her partner's imperfections without feeling the urge to change them. It is scored using a 7-point Likert Scale. 1=totally disagree and 7=totally agree. Higher scores indicate greater acceptance of imperfections.	Baseline, Week 4, 3-Month Follow-Up
Change in Observed Mindfulness Measure	The Observed Mindfulness Measure is a 9 item questionnaire answered by the participant about what they observe about their partner's mindfulness. It is scored on a 5-point Likert scale where 1=not at all and 5=all the time. Scores range from 9-45, with higher scores indicating less mindfulness.	Baseline, Week 4, 3-Month Follow-Up
Change in Loneliness Measured by NIH Toolbox Loneliness Score	The NIH Toolbox Loneliness is a 5-item questionnaire where participants report how often in the past week they have felt loneliness. It is scored on a 5-point Likert scale where 1 = never to 5 = always. The total possible range of scores is 5-25 where higher scores indicate a greater sense of loneliness.	Baseline, Week 4, 3-Month Follow-Up
Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score	The GAD-7 is a 7-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 to 3 = nearly every day. The total possible range of scores is 0-21 where higher scores indicate more anxious symptoms.	Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2 Year Follow-Up
Change in Healthy Minds (HM) Index	The HM Index is a 17-item questionnaire assessing qualities trained in the HMP app (awareness, connection, insight, purpose). It is scored on a 0- to 4-point Likert scale where 0 = a low amount (e.g., never, not at all, none of the time) and 4 = a higher amount (e.g., always, to the highest degree, all of the time) of a particular quality. Total scores for the four subscales range as follows: Awareness (0 to 16), Connection (0 to 24), Insight (0 to 12), Purpose (0 to 16) where higher scores indicate more of each quality.	Baseline, Week 4, 3-Month Follow-Up
Change in the Mindful Attention Awareness Scale (MAAS)	The trait MAAS is a 15-item scale designed to assess a core characteristic of mindfulness, namely, a receptive state of mind in which attention, informed by a sensitive awareness of what is occurring in the present, simply observes what is taking place. It is scored on a 6-point Likert scale, where 1=almost always and 6=almost never. Scores range from 15-90 with higher scores indicating lower attention to what is taking place.	Baseline, Week 4, 3-Month Follow-Up
Change in Conflict Resolution Scale	Conflict Resolution Scale asks participants to select the rating that best describes the outcomes of their disagreements. Scores are summed to get a total score of 0-12 where lower scores indicate worse conflict resolution.	Baseline, Week 4, 3-Month Follow-Up
Digital Working Alliance Inventory	The Digital Working Alliance Inventory is a 6-item scale where participants report their working alliance with the HMP app (e.g., "The HMP app supports me to overcome challenges"). It is scored on a 7-point Likert scale where 1 = "strongly disagree" to 7 = "strongly agree." Total scores range from 6 to 42 where higher scores indicate greater working alliance.	Week 4, 3-Month Follow-Up
Change in Alcohol Use Disorders Identification Test (AUDIT)	AUDIT is a 10-item survey asking about the participant's relationship to alcohol. It is scored using various scales depending on the item. Scores range from 0 to 40, with higher scores indicating greater risk for alcohol use disorder.	Baseline, Week 4, 3-Month Follow-Up
Change in Cannabis Use Disorders Identification Test - Revised (CUDIT-R)	CUDIT-R is an 8-item survey asking about the participant's relationship to cannabis. It is scored using various scales depending on the item. Scores range from 0 to 32, with higher scores indicating greater risk for cannabis use disorder.	Baseline, Week 4, 3-Month Follow-Up
Change in Mild-to-moderate IPV Questionnaire	Mild-to-moderate IPV Questionnaire is an 7-item survey asking about mild-to-moderate violence in the participant's relationship. It is scored using a 7-point Likert scale, with 0 = never and 6 = more than 20 times. Scores range from 0 to 42, with higher scores indicating greater mild-to-moderate violence in the participant's relationship.	Baseline, Week 4, 3-Month Follow-Up
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.	Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
Change in Partner 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 Partner 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
Inventory of Meditation Experiences - Self Report	A 30-item survey scored on a 6-point likert scale from 0 (no, not at all) to 5 (extreme). This is scored on 3 domains: distortion in self/reality, disabling, and enabling. The total possible range of scores for each domain is 0-50 where higher scores indicate increases in the perceived behavior described because of meditation.	Week 4, 3-Month Follow-Up
Inventory of Meditation Experiences - Partner Report	A 30-item survey scored on a 6-point likert scale from 0 (no, not at all) to 5 (extreme) that one partner completes about what they've observed in the other partner's behavior. This is scored on 3 domains: distortion in self/reality, disabling, and enabling. The total possible range of scores for each domain is 0-50 where higher scores indicate increases in the perceived behavior described because of meditation.	Week 4, 3-Month Follow-Up
Number of Participants who donate their Study Compensation	To explore the effect of meditation on altruism.	3-Month Follow-Up

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: March 26, 2025
• First Posted (Actual): April 2, 2025

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: romantic relationship; long-term relationship
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: 2025-0357; A171600 (Other Identifier: UW Madison); EDUC/COUNSELING PSYCH (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No