Individual PE vs Couples' CBT for Combat-Related Posttraumatic Stress Disorder

NCT02336971 | Completed Phase 3 DMC

• 1 other identifier: RyersonU
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief Summary

This study seeks to enroll 76 couples in which one of the members is a combat-veteran with PTSD. Each couple will be randomized into one of two cognitive-behavioral therapies developed specifically as a treatment for PTSD-either Prolonged Exposure (PE) \[1-4\] or Cognitive-Behavioral Couples Therapy (CBCT) \[5-7\]. Whereas, PE was developed as a one-on-one therapy that focuses on treating the individual, CBCT for PTSD incorporates the partners into therapy and seeks to directly address relationship functioning while treating the PTSD symptomatology. Both partners in each couple will complete a battery of several assessments measuring various aspects of psychological distress (e.g., depression, PTSD) and relationship functioning at five time-points throughout the study. But, only the partners assigned to the CBCT group will be involved in the actual therapy sessions. Analysis will be carried out to identify whether any significant differences exist between PE and CBCT in treating PTSD and improving relationship functioning.

Conditions

PTSD; Marital Relationship

Outcome Measures

Primary Outcomes (1)

• PTSD symptoms, as measured by the CAPS and PCL

  Post-treatment (approximately 12 weeks)

Secondary Outcomes (2)

• PTSD symptoms, as measured by the CAPS and PCL

  3, 6 and 12 month follow-ups

• Relationship outcomes, as measured by the Couples Satisfaction Index

  Post-treatment (approximately 12 weeks), 3, 6 and 12 month follow-ups

Study Arms (2)

CBCT for PTSD

EXPERIMENTAL

CBCT for PTSD is a time-limited, problem-focused treatment that aims to improve PTSD and relationship functioning. The study investigators have developed a 15-session treatment plan each session lasting 75-minutes. The treatment is sequenced such that the rationale and psychoeducation provide the basis for the behavioral skills training designed to improve communication and relationship functioning, and to overcome behavioral and experiential avoidance. These skills are used in the final phase of the treatment that is focused on cognitive mechanisms contributing to PTSD and relationship dysfunction.

Behavioral: CBCT for PTSD

Prolonged Exposure

EXPERIMENTAL

PE for combat-related stress disorders \[13-14\] serves as the comparison treatment. The therapy is usually conducted in 10-12 sessions, each lasting 90-minutes, with the majority of the sessions devoted to imaginal exposure to traumatic memories and homework assignments that include in vivo exposure assignments. In the present study, participants will complete 12 sessions of PE to equate the number of sessions with those of CBCT. Partners of individuals with PTSD are not typically incorporated into the treatment program and so for this study a revised version of PE \[1-3\] will be administered in which the partner is seen during the second session to discuss PTSD, other reactions to trauma and the treatment procedures.

Behavioral: Prolonged Exposure

Interventions

CBCT for PTSD BEHAVIORAL

CBCT consists of three phases of treatment: Phase 1: treatment orientation and education about PTSD and its related intimate relationship problems Phase 2: behavioral communication skills training Phase 3: cognitive interventions based on Cognitive Processing Therapy (CPT)

CBCT for PTSD

Prolonged Exposure BEHAVIORAL

PE consists of: psychoeducation and some limited distress management training, but emphasizes the role of imaginal and in vivo exposure in treating PTSD.

Prolonged Exposure

Eligibility Criteria

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

You may qualify if:

• Married or cohabitating couples who have been together the past 3 months in which one partner is an OEF/OIF/OND veteran with PTSD. Diagnosis of PTSD will be determined by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). The 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 OIF/OEF/OND. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
• Both individuals must be willing to make a commitment to treatment as prescribed by their randomization in this study.
• Speak and read English.
• Be stable for at least 6 weeks on any psychotropic medications either partner may be taking. This criterion is established in order to minimize the likelihood that significant outcome effects may be attributed to changes in psychotropic medications rather than to the treatment protocol.

You may not qualify if:

• Evidence or admission of severe intimate aggression as indicated by a "yes" endorsement to the one-question screen for severe violence items by either member of the couple occurring within the past 6-months.
• Partner with PTSD symptoms on the Life Events Checklist (LEC), Deployment Risk and Resilience Inventory (DRRI) subscales (if active duty and is a Veteran of deployment), and PTSD CheckList - Stressor Specific (PCL-S) warranting primary treatment for him or herself.
• Recent initiation of other treatment (i.e., drug/alcohol treatment) or an identified immediate need for other treatment (i.e., severe suicide risk, current alcohol dependence).
• Current suicidal ideation severe enough to warrant immediate attention (as determined by the Scale for Suicidal Ideation)
• Alcohol dependence as assessed using the Alcohol Use Disorders Identification Test (AUDIT).
• Any severe cognitive impairment that precludes retention of session content across sessions or an ongoing psychotic or bipolar disorder.

Sponsors & Collaborators

• Toronto Metropolitan University: lead

Study Sites (3)

Fort Hood Military Base

Fort Hood, Texas, 76544, United States

Location

Brooke Army Medical Center, Fort Sam Houston

Fort Sam Houston, Texas, 78234, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (13)

• Foa EB, Rothbaum BO, Riggs DS, Murdock TB. Treatment of posttraumatic stress disorder in rape victims: a comparison between cognitive-behavioral procedures and counseling. J Consult Clin Psychol. 1991 Oct;59(5):715-23. doi: 10.1037//0022-006x.59.5.715.

  PMID: 1955605 BACKGROUND

• Foa EB, Dancu CV, Hembree EA, Jaycox LH, Meadows EA, Street GP. A comparison of exposure therapy, stress inoculation training, and their combination for reducing posttraumatic stress disorder in female assault victims. J Consult Clin Psychol. 1999 Apr;67(2):194-200. doi: 10.1037//0022-006x.67.2.194.

  PMID: 10224729 BACKGROUND

• Foa EB, Hembree EA, Cahill SP, Rauch SA, Riggs DS, Feeny NC, Yadin E. Randomized trial of prolonged exposure for posttraumatic stress disorder with and without cognitive restructuring: outcome at academic and community clinics. J Consult Clin Psychol. 2005 Oct;73(5):953-64. doi: 10.1037/0022-006X.73.5.953.

  PMID: 16287395 BACKGROUND

• Foa EB, Hembree EA, Rothbaum BO. Prolonged exposure therapy for PTSD: Emotional processing of traumatic experiences - therapist guide. 2007. Oxford University Press.

  BACKGROUND

• Monson CM, Schnurr PP, Stevens SP, Guthrie KA. Cognitive-Behavioral Couple's Treatment for posttraumatic stress disorder: initial findings. J Trauma Stress. 2004 Aug;17(4):341-4. doi: 10.1023/B:JOTS.0000038483.69570.5b.

  PMID: 15462542 BACKGROUND

• Monson CM, Rodriguez BF, Warner R. Cognitive-behavioral therapy for PTSD in the real world: do interpersonal relationships make a real difference? J Clin Psychol. 2005 Jun;61(6):751-61. doi: 10.1002/jclp.20096.

  PMID: 15546144 BACKGROUND

• Carroll EM, Rueger DB, Foy DW, Donahoe CP Jr. Vietnam combat veterans with posttraumatic stress disorder: analysis of marital and cohabitating adjustment. J Abnorm Psychol. 1985 Aug;94(3):329-37. doi: 10.1037//0021-843x.94.3.329. No abstract available.

  PMID: 4031230 BACKGROUND

• Gold JI, Taft CT, Keehn MG, King DW, King LA, Samper RE. PTSD symptom severity and family adjustment among female Vietnam veterans. Military Psychology. 2007;19:71-81.

  BACKGROUND

• Jordan BK, Marmar CR, Fairbank JA, Schlenger WE, Kulka RA, Hough RL, Weiss DS. Problems in families of male Vietnam veterans with posttraumatic stress disorder. J Consult Clin Psychol. 1992 Dec;60(6):916-26. doi: 10.1037//0022-006x.60.6.916.

  PMID: 1460153 BACKGROUND

• MacDonald C, Chamberlain K, Long N, Flett R. Posttraumatic stress disorder and interpersonal functioning in Vietnam War veterans: a mediational model. J Trauma Stress. 1999 Oct;12(4):701-7. doi: 10.1023/A:1024729520686.

  PMID: 10646188 BACKGROUND

• Riggs DS, Byrne CA, Weathers FW, Litz BT. The quality of the intimate relationships of male Vietnam veterans: problems associated with posttraumatic stress disorder. J Trauma Stress. 1998 Jan;11(1):87-101. doi: 10.1023/A:1024409200155.

  PMID: 9479678 BACKGROUND

• Foa EB, Hembree EA, Dancu CV, Peterson AL, Cigrang JA, Riggs DS. Prolonged exposure treatment for combat-related stress disorders - provider's treatment manual. 2008. Unpublished manual.

  BACKGROUND

• Nacasch N, Foa EB, Fostick L, Polliack M, Dinstein Y, Tzur D, Levy P, Zohar J. Prolonged exposure therapy for chronic combat-related PTSD: a case report of five veterans. CNS Spectr. 2007 Sep;12(9):690-5. doi: 10.1017/s1092852900021520.

  PMID: 17805215 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Candice M Monson, PhD

  Toronto Metropolitan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 19, 2014
• First Posted: January 13, 2015
• Study Start: November 1, 2011
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 7, 2016

Record last verified: 2016-10

Locations

US (3)