Depression DisordersCaresNCT06907654
Couples' Affect in Relationships Study
A study testing well-being app and List of well-being resources in people with Depression Disorders, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression Disorders
- What is being tested?
- well-being app and List of well-being resources
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 9Show fewer
- Did not pass video attention check
- Investigators may also track the time it takes for participants to complete surveys and use survey timing as a method to flag for suspicious bot activity
- Participant presents false or misleading information or other indicators that the participant may be participating in the study in bad faith. At screening, each participant's address will be checked and they will be excluded if the address is 1) invalid or 2) a non-residential address. Participants will also be excluded if the same email is provided for both partners. Participants will be excluded if they fail the attention check item in the baseline survey. Participants will be excluded if they complete their screeners <= 20 minutes of each other.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lily Smith contact
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53705
Lily Smith, cares@chm.wisc.edu
Simon Goldberg, PhD
About this study
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.
Read the 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.
- Conditions
- Depression Disorders
- Being tested
- well-being app, List of well-being resources
- Keywords
- romantic relationship, long-term relationship
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
well-being appDevice
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 resourcesBehavioural
Participants will be given a list of resources that promote well-being.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: well-being app |
| List of well-being resources | Experimental | Primary participants will be instructed to use a curated list of well-being resources. Receives: Behavioral: List of well-being resources |
| Partner - Surveys only | No intervention | Partner participants will complete surveys their thoughts and feelings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
Secondary outcomes (24)
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.
Measured: Baseline, Week 4, 3-Month Follow-Up
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2-Year Follow-Up
Relationship Longevity
The relationship longevity questionnaire asks participants about their relationship status at the end of study participation.
Measured: 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.
Measured: 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)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 4, 3-Month 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.
Measured: 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.
Measured: Week 4, 3-Month Follow-Up
Number of Participants who donate their Study Compensation
To explore the effect of meditation on altruism.
Measured: 3-Month Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start4 Aug 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907654
- Sponsor's protocol ID
- 2025-0357
- Other IDs
- A171600, EDUC/COUNSELING PSYCH
- Acronym
- Cares
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Couples' Affect in Relationships Study
- ClinicalTrials.gov ID
- NCT06907654
- Acronym / sponsor ID
- Cares / 2025-0357
- Conditions
- Depression Disorders
- Keywords
- romantic relationship, long-term relationship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 4 Aug 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The Healthy Minds Program (HMP) mobile application | Experimental | Device: well-being appPrimary participants in the HMP group will be instructed to complete a 4-week intervention through the app. |
| List of well-being resources | Experimental | Behavioral: List of well-being resourcesPrimary participants will be instructed to use a curated list of well-being resources. |
| Partner - Surveys only | No intervention | –Partner participants will complete surveys their thoughts and feelings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| well-being appThe 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. | Device | The Healthy Minds Program (HMP) mobile application |
| List of well-being resourcesParticipants will be given a list of resources that promote well-being. | Behavioural | List of well-being resources |
Primary outcome
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
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.
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
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.
24 secondary outcomes
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
Change in Loneliness Measured by NIH Toolbox Loneliness Score
Time frame: Baseline, Week 4, 3-Month Follow-Up
Change in Anxiety Symptoms Measured by Generalized Anxiety Disorder - 7 (GAD-7) Score
Time frame: Baseline, Week 4, 3-Month Follow-Up, 1-Year Follow-Up, 2 Year Follow-Up
Change in Healthy Minds (HM) Index
Time frame: Baseline, Week 4, 3-Month Follow-Up
Change in the Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline, Week 4, 3-Month Follow-Up
Change in Conflict Resolution Scale
Time frame: Baseline, Week 4, 3-Month Follow-Up
Digital Working Alliance Inventory
Time frame: Week 4, 3-Month Follow-Up
Change in Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline, Week 4, 3-Month Follow-Up
Change in Cannabis Use Disorders Identification Test - Revised (CUDIT-R)
Time frame: Baseline, Week 4, 3-Month Follow-Up
Change in Mild-to-moderate IPV Questionnaire
Time frame: Baseline, Week 4, 3-Month Follow-Up
Inventory of Meditation Experiences - Self Report
Time frame: Week 4, 3-Month Follow-Up
Inventory of Meditation Experiences - Partner Report
Time frame: Week 4, 3-Month Follow-Up
Number of Participants who donate their Study Compensation
Time frame: 3-Month Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lily Smith contact
Simon Goldberg, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing well-being app and List of well-being resources in people with Depression Disorders, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lily Smith (cares@chm.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.