Two-Session Couples Class to Improve Relationship Health

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.

Study Overview

• Status: Terminated
• Conditions: Stress
• Intervention / Treatment: Behavioral: Mindfulness Compassion (MC); Behavioral: Mindfulness Gratitude (MG); Behavioral: Mindfulness Value-Based Living (MV)

Detailed Description

Participants will be randomly assigned to one of four conditions, each of which involve participating in two 45-minute sessions (via Zoom) with a study interventionist. Sam Houston State University (SHSU) clinical psychology master's or doctoral students or graduates of the SHSU clinical psychology master's program will implement the mind-body intervention, under the supervision of Dr. Chelsea Ratcliff, who is a licensed psychologist. Dr. Ratcliff will provide weekly group supervision to all students implementing the treatment.

Participation in this study will last a total of 6 weeks (+/- 1 week). The T1 survey will last approximately 45 minutes. Within 1 week of both partners completing baseline, eligible dyads will be scheduled for Session 1. For the intervention, all participants will be emailed a PDF of the appropriate workbook prior to Session 1. Participants will also be informed that they may pick up a hard copy (printed version).

For participants in the stress-reduction groups, after each session the interventionist will send each participant an email with: 1) the audio recording of the appropriate guided stress-reduction activity (transcript provided in workbook), 2) a fillable PDF document with instructions regarding completing and documenting home-practice, and 3) a link to a Qualtrics survey that asks them to evaluate their experience in the session. The instructor will also inform participants that they may pick up hard copies of all session materials if it is convenient/preferable. For participants in the non-intervention control group, the interventionist will email each participant a link to a Qualtrics survey that asks them to evaluate their experience in the session.

Session 2 will take place approximately 1 week after Session 1. After completing session 2, the interventionist will send a link to another Qualtrics survey that asks them to evaluate their experience in the session.

Within 1 week of completing Session 2, both members of the dyad will be emailed the link to the second Qualtrics survey (T2), which will last approximately 30 minutes. Finally, within 1 month (+/- 1 week) of completing Session 2, both members of the dyad will be emailed the third Qualtrics survey (T3), which will last approximately 20 minutes.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Huntsville, Texas, United States, 77340
      • Sam Houston State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness + Compassion (MC); For 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.	Behavioral: Mindfulness Compassion (MC); 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.
Experimental: Mindfulness + Gratitude (MG); Session 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.	Behavioral: Mindfulness Gratitude (MG); 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.
Experimental: Mindfulness + Value-Based Living (MV); Session 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.	Behavioral: Mindfulness Value-Based Living (MV); 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.
No Intervention: Attention Control (AC); For 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyadic Adjustment Scale Total Score	Dyadic Adjustment Scale (DAS-7) (Hunsley, Best, Lefebvre, & Vito, 2001; Spanier, 1976) is a 7-item scale designed to measure adjustment and satisfaction among married or cohabitating couples. Scores range from 0 to 36, with a higher score indicating more positive relationship quality. It has been used in sample of college-aged couples in previous literature.	within 1 week of treatment ending
Dyadic Adjustment Scale Total Score	Dyadic Adjustment Scale (DAS-7) (Hunsley, Best, Lefebvre, & Vito, 2001; Spanier, 1976) is a 7-item scale designed to measure adjustment and satisfaction among married or cohabitating couples. Scores range from 0 to 36, with a higher score indicating more positive relationship quality. It has been used in sample of college-aged couples in previous literature.	1 month after treatment ends
Five Facet Mindfulness Scale Total Score	Five Facet Mindfulness Scale (FFMQ) (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006) is a 39-item scale based on a factor analytic study of five independently developed mindfulness questionnaires, which yielded five factors of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-196 with higher scores indicating greater trait mindfulness.	Within 1 week of treatment completion
Five Facet Mindfulness Scale Total Score	Five Facet Mindfulness Scale (FFMQ) (Baer, Smith, Hopkins, Krietemeyer, & Toney, 2006) is a 39-item scale based on a factor analytic study of five independently developed mindfulness questionnaires, which yielded five factors of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Total scores range from 39-196 with higher scores indicating greater trait mindfulness.	1 month after treatment ends

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance & Action Questionnaire-II Total Score	Acceptance & Action Questionnaire-II (AAQ-II), a 10 question measure of psychological flexibility (Bond et al., 2011). Scores range from 20-70, with higher scores representing greater psychological flexibility.	Within 1 week of treatment completion
Acceptance & Action Questionnaire-II Total Score	Acceptance & Action Questionnaire-II (AAQ-II), a 10 question measure of psychological flexibility (Bond et al., 2011). Scores range from 20-70, with higher scores representing greater psychological flexibility.	1 month after treatment ends
Center for Epidemiologic Studies Depression Scale	Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) a 20-item self-report measure of depression. Scores range from 0-60 with higher scores indicating greater depression symptoms.	Within 1 week of treatment completion
Center for Epidemiologic Studies Depression Scale	Center for Epidemiologic Studies Depression Scale (CES-D; Radloff, 1977) a 20-item self-report measure of depression. Scores range from 0-60 with higher scores indicating greater depression symptoms.	1 month after treatment ends
Medical Outcomes Study 36-item Short-Form Survey (SF-36) Physical Component Summary (PCS)	Physical health-related QOL will be assessed with the Medical Outcomes Study 36-item short-form survey (SF-36) Physical Component Summary (Ware, Johnston, Davies-Avery, & al, 1994). Scores range from 0-100, with higher scores indicating better physical health-related QOL.	Within 1 week of treatment completion
Medical Outcomes Study 36-item Short-Form Survey (SF-36) Physical Component Summary (PCS)	Physical health-related QOL will be assessed with the Medical Outcomes Study 36-item short-form survey (SF-36) physical component summary.(Ware, Johnston, Davies-Avery, & al, 1994). Scores range from 0-100, with higher scores indicating better physical health-related QOL.	1 month after treatment ends
Medical Outcomes Study 36-item Short-Form Survey (SF-36) Mental Component Summary (MCS)	Mental health-related QOL will be assessed with the Medical Outcomes Study 36-item short-form survey (SF-36) mental component summary.(Ware, Johnston, Davies-Avery, & al, 1994). Scores range from 0-100, with higher scores indicating better mental health-related QOL.	Within 1 week of treatment completion
Medical Outcomes Study 36-item Short-Form Survey (SF-36) Mental Component Summary (MCS)	Mental health-related QOL will be assessed with the Medical Outcomes Study 36-item short-form survey (SF-36) mental component summary.(Ware, Johnston, Davies-Avery, & al, 1994). Scores range from 0-100, with higher scores indicating better mental health-related QOL.	1 month after treatment ends

Collaborators and Investigators

• Sponsor: Sam Houston State University
• Investigators: Principal Investigator: Chelsea G Ratcliff, Ph.D., Sam Houston State University

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: couples stress, health, psychology
• Other Study ID Numbers: IRB-2019-123

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No