Mindfulness in Couples

NCT07433582 | Recruiting

• 2 other identifiers: ECSW-2025-134R1406.23.PPO.023
• Study Type: interventional
• Target: 426
• Locations: 1 country
• Sites: 1

Brief Summary

Considering the high prevalence of couple distress in Western countries and rising divorce rates, there is a pressing need for accessible and evidence-supported interventions that can strengthen relationship functioning. Although mindfulness has been positively linked to relationship functioning, only few studies have investigated the effects of mindfulness interventions specifically targeted at couples. However, these studies suffer from methodological limitations such as lack of an active control group. To address this gap, a feasibility trial with progression to a full-scale randomized controlled trial (RCT) will be conducted, depending on whether stoppage criteria are met, to evaluate the effectiveness of a Mindfulness-Based Couple Intervention (MBCI) compared to an online active control intervention (Self-expansion Intervention) and waitlist control group. Moreover, consolidation of intervention effects is examined up to 6 months post-intervention. Finally, possible working mechanisms and the effect of potential moderators are examined. The current study has three arms: (i) MBCI, (ii) active control intervention (i.e., a self-expansion program) and (iii) waitlist control, with assessments at baseline (T0), immediately post-intervention (T1) and at 6 months post-intervention (T2). After the follow-up assessments, waitlisted participants are offered to take part in (an online version of) either the MBCI or the active control intervention. The study aims to include 213 couples (426 participants, age \>20 years) with a minimum relationship duration of 2 years. Couples will be randomly assigned with a 3:3:2 ratio to MBCI, Self-expansion or waitlist, respectively (with a total of 80 couples in the intervention groups and 53 couples in the waitlist control group). This is a multi-site RCT, with five different centers spread across the Netherlands, based in Nijmegen, Tilburg, Amsterdam, Maastricht and Groningen. In the feasibility phase, 42 eligible couples will be recruited from two sites (Nijmegen and Tilburg). Stratified variable block randomization will be used(block sizes of 8 and 16), with study site as stratification factor. The MBCI is a close adaptation of the widely used and well-researched Mindfulness-Based Stress Reduction program (MBSR), developed by our research team. Couples learn how to practice mindfulness meditation and how to apply mindfulness in their daily life and in their relationship. As compared to the MBSR, it includes adapted and additional exercises to practice mindfulness within the relationships, such as mindful communication exercises, mindful touch, and mindfully viewing one's partner. The active control intervention encourages couples to invest in self-expansion, by doing a novel activity together every week. This intervention is based on self-expansion theory. According to this theory, couples are satisfied with their relationship as long as they experience a sense of self-expansion. A sense of self-expansion can be promoted by engaging in novel activities together and gaining new insights from each other. Both the mindfulness- and self-expansion interventions consist of 8 weekly sessions, plus a silent day (for MBCI) or a day out (for the self-expansion intervention). Interventions are similar in non-specific factors such as format, structure, time commitment, teacher support, and group dynamics. The primary outcome is to compare self-reported relationship satisfaction as measured by the Couple Satisfaction Index (CSI-4) from pre-intervention (T0) to immediately post-intervention (T1) between the MBCI group compared to the active control group and between the MBCI group compared to the waitlist control group. Secondary outcomes include the difference in relationship satisfaction from pre-intervention (T0) to 6 month post-intervention (T2) between participants in the MBCI compared to the active and waitlist control group, as well as differences between participants in the MBCI compared to the active and waitlist control group in various relationship behaviors, perceptions of the partner, and individual outcomes measured from pre-intervention (T0) to immediately post-intervention (T1) and pre-intervention (T0) to 6 months post-intervention (T2). In addition, a number of potential moderators, including commitment, attachment style and trait mindfulness measured at T0 will be assessed to determine for whom these programs work. Unless the trial team determines, based on stoppage criteria, that trial procedures need important modifications thereby re-setting the full-scale trial as a new trial, the outcome data of the participants in the feasibility portion will be utilized in the analyses of the full-scale trial.

Conditions

Romantic Relationship Functioning

Keywords

Romantic relationship; Mindfulness; Self-expansion; Relationship satisfaction; Couple intervention; MBSR

Outcome Measures

Primary Outcomes (1)

• Difference in Couple Satisfaction Index-4 scores between participants in the MBCI arm and waitlist control, between participants in the SE arm and waitlist control, and between participants in the MBCI arm and SE arm immediately post-intervention

  The Couple Satisfaction Index (4 items, CSI-4) measures relationship satisfaction, a global assessment of contentment in the romantic relationship. The first item is measured on a 7-point Likert scale (0=extremely unhappy, 6=perfect), the other items on a 5-point Likert scale (0=not at all, 5=completely). Maximum score =22. Higher scores indicate higher satisfaction.

  Time Frame: 1 week post-intervention

Secondary Outcomes (15)

• Difference in Couple Satisfaction Index-4 scores between participants in the MBCI arm and waitlist control, between participants in the SE arm and waitlist control, and between participants in the MBCI arm and SE arm immediately post-intervention

  6 months post-intervention

• Relationship distress: Multidimension Stress Questionnaire for couples (MSF-P)

  1 week post-intervention and 6 months post-intervention

• Emotional intimacy: Perceived Relationship Quality Component scale (PRQC)

  1 week post-intervention and 6 months post-intervention

• Perceived Partner Responsiveness: Perceived Responsiveness and Insensitivity scale (PRI)

  1 week post-intervention and 6 months post-intervention

• Capitalization: Perceived Responses to Capitalization Attempts scale (PRCA)

  1 week post-intervention and 6 months post-intervention

Other Outcomes (9)

• Pre measurement commitment as a moderator of the effect of MBCI on change in relationship satisfaction from pre to post and pre to follow up compared to active and waitlist control groups.

  Pre measurement in the month before start of the intervention.

• Pre measurement attachment style as a moderator of the effect of MBCI on change in relationship satisfaction from pre to post and pre to follow up compared to active and waitlist control groups.

  Pre measurement in the month before start of the intervention.

• Expectancy of the training

  After randomization, before start of the intervention.

Study Arms (3)

Mindfulness-Based Couple Intervention

EXPERIMENTAL

The Mindfulness-based Couple Intervention (MBCI) was designed by our research team. It consists of 8 weekly group sessions lasting 2,5 hours, delivered by a certified mindfulness trainer. It is a close adaptation of the widely-used and well-researched Mindfulness-Based Stress Reduction program (MBSR), following the same structure and topics. It teaches participants mindfulness meditation practice and how to apply mindfulness in their daily life and relationship. The sessions include group discussions, psycho-education, mediation practices and exercises done in couples, such as mindful communication exercises and mindful touch exercises. The intervention also involves weekly homework assignments, on which participants are expected to spend around 30-45 minutes per day. It also involves a 6 hour silent meditation retreat.

Behavioral: MBCI

Self-expansion training

ACTIVE COMPARATOR

The self-expansion training was designed by our research team based on the Self-expansion theory. Self-expansion theory states that couples enrich each other's lives by doing novel activities together and gaining new insights from each other, which is beneficial to the relationship. The self-expansion training encourages partners to engage in novel, exciting activities that promote shared growth and is inspired by earlier self-expansion studies in which participants choose novel, exciting activities from a list. In our intervention, couples are asked to choose and complete a new activity aligned with a specific theme (e.g., physical exercise or creativity) every week, on which they spend approximately 2 hours or longer. During the sessions, participants share their experiences of the activities they have done. Sessions last 1 hour and 15 minutes and are delivered online (because of feasibility reasons). It includes an additional day out of approximately 6 hours.

Behavioral: SE training

Waitlist control

NO INTERVENTION

Participants in the waitlist control group do not follow an intervention for the duration of the study. After having completed the measurements, they have the option to follow an online version of one of the two interventions for free.

Interventions

SE training BEHAVIORAL

Self-expansion training

Self-expansion training

MBCI BEHAVIORAL

Mindfulness-based Couple Intervention (MBCI)

Mindfulness-Based Couple Intervention

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \>20 years
• relationship duration of \>2 years

You may not qualify if:

• One or both partners have followed an MBSR- or MBCT training or similar mindfulness program for at least four sessions in the past three years.
• One or both partners are currently in relationship therapy.
• One or both partners are unable to sufficiently speak and understand the Dutch language.
• Presence of severe mental disorders in one or both partners, namely addiction, suicidality (in the past 12 months) or psychosis (in the past 12 months?).
• Presence of partner violence (in the last 12 months)

Sponsors & Collaborators

• Behavioural Science Institute: lead
• Radboud University Medical Center: collaborator

Study Sites (1)

Behavioral Science Institute, Radboud University

Nijmegen, Gelderland, 6525GD, Netherlands

RECRUITING

Central Study Contacts

Johan C.T.M. Karremans, Prof. PhD

CONTACT

+31616805575; johan.karremans@ru.nl

Linda Kwakkenbos, PhD

CONTACT

+31641450052; linda.kwakkenbos@ru.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Model Details: Participants will be randomly assigned to one of three groups in parallel for the duration of the study. Participants in the waitlist condition have the option to follow (an online version of) one of the interventions after they have completed all trial measurements.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 25, 2026
• Study Start: March 3, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 12 months after the collection of the primary outcome
• Access Criteria: Approval of proposed purpose for data access

Locations

NL (1)