Two-Session Couples Class to Improve Relationship Health

NCT ID: NCT05026372

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants will not be informed of their group condition, i.e., MC, MG, MV, or AC.

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness Compassion (MC)

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Mindfulness Gratitude (MG)

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Mindfulness Value-Based Living (MV)

Intervention Type BEHAVIORAL

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)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sam Houston State University

OTHER

Sponsor Role lead

Responsible Party

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Chelsea Ratcliff

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chelsea G Ratcliff, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Sam Houston State University

Locations

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Sam Houston State University

Huntsville, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-2019-123

Identifier Type: -

Identifier Source: org_study_id

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