Study Stopped
Participant drop out exceeded expectations (out of 63 couples randomized, 18 completed follow up). Study may be resumed with revised procedures for preventing drop out.
Two-Session Couples Class to Improve Relationship Health
1 other identifier
interventional
126
1 country
1
Brief Summary
This study will compare the effect of three different stress reduction intervention techniques compared to a non-intervention control group on the psychological and relationship functioning in 40 romantic couples. The current study will serve two purposes. Results will inform future efforts to develop effective brief stress reduction interventions for physically healthy couples and will inform future iterations of stress reduction-based intervention for cancer patients and their caregivers. The investigators hypothesize that couples in the three stress-reduction interventions will report greater relationship health and greater mindfulness after the intervention than couples in the non-intervention control group. The investigators also hypothesize that the stress-reduction groups will be most beneficial for individuals who report higher distress, indifferent relationship style, and insecure attachment at baseline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2019
CompletedFirst Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedOctober 24, 2023
April 1, 2023
4 years
August 23, 2021
October 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Perceived Stress Scale
Perceived Stress Scale (PSS) (Cohen \& Janicki-Deverts, 2012) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress
Within 1 week of treatment ending
Perceived Stress Scale
Perceived Stress Scale (PSS) (Cohen \& Janicki-Deverts, 2012) is a 10-item scale to measure stress. Scores range from 0-40, with higher scores indicating greater perceived stress
1 month after treatment ends
Secondary Outcomes (4)
Dyadic Adjustment Scale Total Score
within 1 week of treatment ending
Dyadic Adjustment Scale Total Score
1 month after treatment ends
Five Facet Mindfulness Scale Total Score
Within 1 week of treatment completion
Five Facet Mindfulness Scale Total Score
1 month after treatment ends
Other Outcomes (8)
Acceptance & Action Questionnaire-II Total Score
Within 1 week of treatment completion
Acceptance & Action Questionnaire-II Total Score
1 month after treatment ends
Center for Epidemiologic Studies Depression Scale
Within 1 week of treatment completion
- +5 more other outcomes
Study Arms (4)
Mindfulness + Compassion (MC)
EXPERIMENTALFor participants randomized to the MC condition will focus on compassion and creating positive emotions. This session will include techniques such as guided visualizations and a loving kindness meditation that are intended to facilitate connection with their partners. During this session, couples will also learn the ground rules of mindful and compassionate listening and sharing, as they will be asked to engage in an emotional disclosure task. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
Mindfulness + Gratitude (MG)
EXPERIMENTALSession 2 for participants randomized to group MG will focus on gratitude. Participants will be taught to reflect on things, events, and people which they are grateful for via a gratitude meditation. Couples will share their experiences of practicing gratitude. The instructor will remind the couple of ground rules prior to the emotional disclosure exercise and facilitate if necessary during the sharing. Each member of the couple will take turn in sharing with and listening to their partner. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
Mindfulness + Value-Based Living (MV)
EXPERIMENTALSession 2 for participants randomized to group MV will focus on learning strategies to live life according to their values. They will first engage in a reflection exercise to help identify their values, and then complete a worksheet. Couples will brain storm together strategies to ensure that their lives reflect their self-identified values. The instructor will go over the homework assignment. The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
Attention Control (AC)
NO INTERVENTIONFor participants randomized to the AC condition, both sessions will focus on discussing issues and themes that emerge for couples, such as communication and perceived supportiveness. Utilizing a reflective listening approach, the interventionist will focus on encouraging participants to share concerns related to their daily experiences. Unlike in the MC, MG, and MV groups, the interventionist will not offer advice, support (other than reflective listening) or any other tools to participants. Additionally, the interventionist will not probe for deep emotional disclosure. Please see the appendix for the session outline. We believe a control group that discusses daily relationship-related concerns serves as an excellent comparison condition in this study since it is viewed as credible by participants and equates for time and attention as well as nonspecific treatment effects such as those provided through social interactions.
Interventions
The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
Eligibility Criteria
You may qualify if:
- ADULT ROMANTIC COUPLES in a relationship for a minimum of 6 months COHABITATING for a minimum of 6 months STRESS. At least one member of the romantic dyad reports stress above the normative mean for young adults (i.e., Perceived Stress Scale score \> 17; Cohen \& Janicki-Deverts, 2012).
You may not qualify if:
- INDIVIDUALS UNDER AGE 18: This study only involves adult participants. NON-ENGLISH SPEAKING INDIVIDUALS: This study only involves participants who can speak English.
- ATTENDING PSYCHOTHERAPY: This stud only involves individuals who are not currently (self-defined) participating in psychotherapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sam Houston State University
Huntsville, Texas, 77340, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Chelsea G Ratcliff, Ph.D.
Sam Houston State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will not be informed of their group condition, i.e., MC, MG, MV, or AC.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 30, 2021
Study Start
May 29, 2019
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
October 24, 2023
Record last verified: 2023-04