Couple's Retreats for Posttraumatic Stress Disorder

NCT05274061 | Terminated

• 1 other identifier: HSC20210843H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) increases the risk for conflict and dissatisfaction in romantic relationships. Accelerated, Intensive, Multi-Couples Cognitive Behavioral Conjoint Therapy (AIM-CBCT) is a behavioral treatment that targets reducing PTSD symptoms and improving relationship functioning. The treatment is delivered over two days using an intensive, outpatient group (between 2 to 6 couples) format. Previous research has found that AIM-CBCT for PTSD decrease PTSD symptoms and improves relationship functioning in military veterans and service members with combat-related PTSD. The present study examines whether these original findings can be replicated in a broader military/Veteran sample of up to 80 couples. The investigators predict that AIM-CBCT for PTSD will be associated with significant decreases in PTSD symptoms, depression, and anxiety in Veteran/military service members, significant decreases in mental health symptoms in their romantic partners, and an increase in couple's satisfaction for both the Veteran/service members and their partners. Couples who agree to participate in the research study will be asked to participate in a 60-mintute pre-retreat meeting, the two-day retreat in which AIM-CBCT for PTSD will be delivered, and a 60-minute post-retreat check-in meeting. Additionally, each member of the couple will be asked to complete measures on their trauma history, mental health symptoms, and relationship functioning at baseline and at two and four weeks after the retreat.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic stress disorder; Conjoint Therapy; Cognitive Behavioral Treatment; Intensive Treatments; Couples; Cognitive Behavioral Conjoint Therapy

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist - DSM-5 (PCL-5)

  Change in scale measurements by the PTSD CheckList-5. The PCL-5 is a 20-item, self-report measure of PTSD symptoms experienced in the past month. Each item is rated on a severity scale ranging from 0 (Not at all) to 4 (Extremely). The measure provides a total severity score that ranges from 0 to 80, with higher scores representing more PTSD symptoms.

  Baseline, two-week post-retreat assessment, one-month post-retreat assessment

Secondary Outcomes (3)

• Patient Health Questionnaire-9 (PHQ-9)

  Baseline, two-week post-retreat assessment, one-month post-retreat assessment

• General Anxiety Disorder - 7 (GAD-7)

  Baseline, two-week post-retreat assessment, one-month post-retreat assessment

• Couples Satisfaction Index-32 (CSI-32)

  Baseline, two-week post-retreat assessment, one-month post-retreat assessment

Study Arms (1)

Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy (AIM-CBCT for PTSD)

EXPERIMENTAL

This is a single-arm study in which each couple will receive AIM-CBCT. The intervention is described in the section below.

Behavioral: Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy

Interventions

Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy BEHAVIORAL

AIM-CBCT consists of an accelerated, 2-day delivery of the first 7 sessions of CBCT for PTSD and is comprised of (a) psychoeducation about PTSD and relationship functioning; (b) instruction in conflict management skills; (c) instruction in effective communication skills with an emphasis on the identification and sharing of emotions to decrease emotional numbing and increase emotional intimacy; (d) discussion of the importance of approaching, rather than avoiding, difficult situations and identification of places, situations, people, and feelings that the couple has heretofore avoided as a result of PTSD; (e) instruction in identification of thoughts and related feelings that can maintain PTSD and relationship distress and strategies to increase cognitive flexibility, and (f) instruction in problem-solving skills to generate couple-level approach behaviors and guidance in how to select activities that double as opportunities to approach feared situations and engage in positive bonding.

Also known as: AIM-CBCT for PTSD

Accelerated, Intensive, Multi-Couple Cognitive Behavioral Couples Therapy (AIM-CBCT for PTSD)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cohabitating couples (ages 18 to 65 years old), who have been together for at least 4 months who reside in Texas.
• At least one partner in the relationship is a Texas Veteran with significant PTSD symptoms as determined by the endorsement of at least one Criterion A event on the Life Event Checklist, the endorsement of at least one re-experiencing on the PCL-5 (i.e., a score of 2 or higher on Items 1, 2, 3, 4, or 5), the endorsement of at least one avoidance symptom on the PCL-5 (i.e., a score of 2 or higher on Items 6 or 7), and a total symptom score of 31 or higher on the PCL-5.
• Both individuals must be willing to participate in the study.
• Both individuals must be able to speak and read English.

You may not qualify if:

• Couple is separated and/or is taking steps to dissolve their relationship (e.g., divorce).
• Veteran or partner are currently participating in an evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).
• Veteran or partner exhibit current psychiatric symptoms warranting immediate intervention that is beyond the scope of the treatment provided in this study.
• Veteran or partner exhibit evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)
• Veteran or partner report current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale; DSI-SS)
• Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question Screen for Conflict Question by Veteran or partner occurring within the past 6-months.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (7)

• Fredman SJ, Le Y, Macdonald A, Monson CM, Rhoades GK, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Jenkins AIC, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. A Closer Examination of Relational Outcomes from a Pilot Study of Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD with Military Dyads. Fam Process. 2021 Sep;60(3):712-726. doi: 10.1111/famp.12654. Epub 2021 Apr 20.

  PMID: 33876831 BACKGROUND

• Fredman SJ, Macdonald A, Monson CM, Dondanville KA, Blount TH, Hall-Clark BN, Fina BA, Mintz J, Litz BT, Young-McCaughan S, Hancock AK, Rhoades GK, Yarvis JS, Resick PA, Roache JD, Le Y, Wachen JS, Niles BL, McGeary CA, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Intensive, Multi-Couple Group Therapy for PTSD: A Nonrandomized Pilot Study With Military and Veteran Dyads. Behav Ther. 2020 Sep;51(5):700-714. doi: 10.1016/j.beth.2019.10.003. Epub 2019 Nov 27.

  PMID: 32800299 BACKGROUND

• Macdonald A, Fredman SJ, Taylor DJ, Pruiksma KE, Blount TH, Hall-Clark BN, Fina BA, Dondanville KA, Mintz J, Litz BT, Young-McCaughan S, Le Y, Jenkins AIC, Monson CM, Yarvis JS, Keane TM, Peterson AL; Consortium to Alleviate PTSD. Secondary individual outcomes following multicouple group therapy for posttraumatic stress disorder: An uncontrolled pilot study with military dyads. J Trauma Stress. 2022 Feb;35(1):321-329. doi: 10.1002/jts.22729. Epub 2021 Nov 20.

  PMID: 34800060 BACKGROUND

• Monson CM, Taft CT, Fredman SJ. Military-related PTSD and intimate relationships: from description to theory-driven research and intervention development. Clin Psychol Rev. 2009 Dec;29(8):707-14. doi: 10.1016/j.cpr.2009.09.002. Epub 2009 Sep 10.

  PMID: 19781836 BACKGROUND

• Monson CM, Fredman SJ. Cognitive-behavioral conjoint therapy for posttraumatic stress disorder: Harnessing the healing power of relationships. New York: Guilford. 2012

  BACKGROUND

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

  PMID: 11556941 BACKGROUND

• Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.

  PMID: 18388841 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Alan L Peterson, PhD

  UT Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an open-label, single group treatment study in which every couple will receive the intervention (AIM-CBCT).

Study Record Dates

• First Submitted: March 1, 2022
• First Posted: March 10, 2022
• Study Start: March 18, 2022
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: July 12, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)