Two-Session Couples Class to Improve Relationship Health

Stress Clinical Trial

Official title:

Two-Session Couples Class to Improve Relationship Health

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05026372
• Other study ID #: IRB-2019-123
• Status: Terminated
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: May 31, 2023

Study information

• Verified date: April 2023
• Source: Sam Houston State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stress

Intervention

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.
• 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)
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.

Locations

Country	Name	City	State
United States	Sam Houston State University	Huntsville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sam Houston State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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