Clinical trial NCT05026372: Two-Session Couples Class to Improve Relationship Health
Official title: Two-Session Couples Class to Improve Relationship Health
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stress
Keywords: couples stress, health, psychology
Lead sponsor: Sam Houston State University
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Within 1 week of treatment ending
measure: Perceived Stress Scale
timeFrame: 1 month after treatment ends
Secondary outcomes:
measure: Dyadic Adjustment Scale Total Score
timeFrame: within 1 week of treatment ending
measure: Dyadic Adjustment Scale Total Score
timeFrame: 1 month after treatment ends
measure: Five Facet Mindfulness Scale Total Score
timeFrame: Within 1 week of treatment completion
measure: Five Facet Mindfulness Scale Total Score
timeFrame: 1 month after treatment ends
Other outcomes:
measure: Acceptance & Action Questionnaire-II Total Score
timeFrame: Within 1 week of treatment completion
measure: Acceptance & Action Questionnaire-II Total Score
timeFrame: 1 month after treatment ends
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Within 1 week of treatment completion
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: 1 month after treatment ends
measure: Medical Outcomes Study 36-item Short-Form Survey (SF-36) Physical Component Summary (PCS)
timeFrame: Within 1 week of treatment completion
measure: Medical Outcomes Study 36-item Short-Form Survey (SF-36) Physical Component Summary (PCS)
timeFrame: 1 month after treatment ends
measure: Medical Outcomes Study 36-item Short-Form Survey (SF-36) Mental Component Summary (MCS)
timeFrame: Within 1 week of treatment completion
measure: Medical Outcomes Study 36-item Short-Form Survey (SF-36) Mental Component Summary (MCS)
timeFrame: 1 month after treatment ends
Locations:
city: Huntsville
country: United States
facility: Sam Houston State University
state: Texas
Study officials:
affiliation: Sam Houston State University
name: Chelsea G Ratcliff, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: