Intensive Weekend Retreat Multi-Couple Group Therapy for PTSD

PTSD Clinical Trial

Official title:

Multi-Couple Group Intervention for PTSD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03158558
• Other study ID #: HSC20160094H
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: February 2018

Study information

• Verified date: December 2018
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test an intensive, multi-couple group version of a couple therapy for PTSD delivered to active duty Service Members or Veterans with PTSD and their romantic partners in a single weekend retreat. The study will be conducted on or near Fort Hood in Kileen, Texas. Twenty-four couples will be treated with this therapy and assessed immediately before treatment, 1 month after treatment, and 3 months after treatment.

Description:

Numerous studies have documented an association between posttraumatic stress disorder (PTSD) symptoms and intimate relationship problems in both Service Members and Veterans and their partners, including relationship distress, physical and psychological aggression, and psychological distress in partners. In prior work, the investigators have demonstrated that cognitive-behavioral conjoint therapy for PTSD (CBCT for PTSD), a 15-session couple-based therapy for PTSD, is efficacious in simultaneously treating PTSD and comorbid symptoms and improving intimate relationship functioning. However, the current format of fifteen 75-minute sessions over 15 weeks presents challenges for large-scale dissemination for active duty Service Members and recently discharged Veterans who have deployed in support of 9/11.

The purpose of this uncontrolled trial is to pilot a brief, scalable version of CBCT for PTSD in which session content is taught in an accelerated, multi-couple group format (AM-CBCT for PTSD) that has the potential for rapid dissemination and implementation, while capturing the majority of the benefits of the original therapy format. Accelerated, multi-couple group CBCT for PTSD (AM-CBCT for PTSD) will be delivered in a single weekend retreat to 24 active duty Service Members and recently discharged Veterans with PTSD who have deployed post-9/11 and their partners. Participants will be assessed at pre-treatment, one month after treatment, and 3 months after treatment.

The study seeks to answer the following questions:

1. Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in clinician-rated PTSD symptom severity, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), one month after treatment and at 3-month follow-up?

2. Will accelerated, multi-couple group CBCT for PTSD delivered in a weekend retreat (AM-CBCT for PTSD) be associated with significant improvements in secondary outcomes (e.g., patient self-reported PTSD and comorbid symptom severity, relationship satisfaction), one month after treatment and at 3-month follow-up?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Married or cohabitating couples who have been together the past 3 months in which one partner is a Service Member or recently discharged Veterans eligible for treatment at Carl R. Darnall Army Medical Center (CRDAMC) with PTSD who has deployed since 9/11, seeking treatment for PTSD.

• Diagnosis of PTSD as determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and a CAPS-5 score > 25. The Service Member or Veteran with PTSD must have experienced a Criterion A event that is a specific combat-related event or high magnitude operational experience that occurred during a military deployment in support of combat operations following 9/11. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.

• Both individuals must be able to speak and read English.

Exclusion Criteria:

• Couple is separated and/or has taken steps to dissolve their relationship (e.g., divorce)

• Currently participating in evidence-based treatment for PTSD (Prolonged Exposure, Cognitive Processing Therapy, or Cognitive-Behavioral Conjoint Therapy for PTSD).

• Recent manic episode (past 12 months) or a psychotic disorder (as determined by the Mania and Psychosis modules of the MINI)

• Current alcohol dependence (as determined by an a score of = 4 on items #4-6 and a total score of =20 on the AUDIT)

• Evidence of a moderate or severe traumatic brain injury (as determined by the inability to comprehend the baseline screening questionnaires)

• 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 either member of the couple occurring within the past 6-months.

• Partner who meets diagnostic criteria for PTSD according to the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) or PTSD Checklist - Stressor Specific (PCL-S).

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Accelerated, Multi-Couple Group CBCT for PTSD
Intensive weekend retreat version of cognitive-behavioral conjoint therapy for PTSD (Monson & Fredman, 2012)

Locations

Country	Name	City	State
United States	University of Texas Health Sciences Center San Antonio	Killeen	Texas

Sponsors (9)

Lead Sponsor	Collaborator
Penn State University	Duke University, Ryerson University, The Citadel, The University of Texas Health Science Center at San Antonio, United States Department of Defense, University of Denver, US Department of Veterans Affairs, VA Boston Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Administered PTSD Scale (CAPS-5)	semi-structured clinician interview to determine presence and severity of PTSD symptoms	change in PTSD symptoms at 1 and 3 months posttreatment
Secondary	PTSD Checklist for DSM-5 (PCL-5)	patient self-report rating of PTSD symptom severity	change in PTSD symptoms at 1 and 3 months posttreatment
Secondary	Patient Health Questionnaire-9 (PHQ-9)	self-report measure of depressive symptom severity	change in PTSD symptoms at 1 and 3 months posttreatment
Secondary	Couples Satisfaction Index (CSI)	self-report measure of relationship satisfaction	change in relationship satisfaction at 1 and 3 months posttreatment