NCT05026372

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

October 24, 2023

Status Verified

April 1, 2023

Enrollment Period

4 years

First QC Date

August 23, 2021

Last Update Submit

October 20, 2023

Conditions

Keywords

couples stress, health, psychology

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)

EXPERIMENTAL

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)

Mindfulness + Gratitude (MG)

EXPERIMENTAL

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)

Mindfulness + Value-Based Living (MV)

EXPERIMENTAL

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)

Attention Control (AC)

NO INTERVENTION

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.

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.

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.

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.

Mindfulness + Value-Based Living (MV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Study Officials

  • Chelsea G Ratcliff, Ph.D.

    Sam Houston State University

    PRINCIPAL INVESTIGATOR

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
Model Details: The intervention conditions are divided into Mindfulness + Compassion (MC), Mindfulness + Gratitude (MG), Mindfulness + Value-Based Living (MV), and Attention Control (AC)) on Mindfulness (FFMQ).
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

Locations