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

PTSD Clinical Trial

Official title:

Individual Prolonged Exposure (PE) Versus Couples' Cognitive-Behavioral Therapy for Combat-Related Posttraumatic Stress Disorder (PTSD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02336971
• Other study ID #: RyersonU
• Status: Completed
• Phase: Phase 3
• First received: December 19, 2014
• Last updated: October 6, 2016
• Start date: November 2011
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Ryerson University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of the proposed study is to examine the effects of Cognitive-Behavioral treatments for PTSD on PTSD symptoms and relationship functioning in active duty military personnel who have recently returned from combat deployment to Operation Enduring Freedom (OEF), Operation Iraqi Freedom (OIF), or Operation New Dawn (OND) and their partners. Research indicates that PTSD is associated with high levels of relationship distress [8-12]. We will compare a treatment specifically designed to incorporate partners, Cognitive-Behavioral Couples Therapy (CBCT), with an established therapy that focuses on treatment of the individual, Prolonged Exposure (PE). CBCT includes techniques designed both to promote support for the traumatized individual and reduce relationship distress; whereas, PE focuses solely on PTSD symptoms and treats only the patient with PTSD. Therefore, we expect to see greater improvement in intimate relationship functioning with CBCT than with PE, while remaining equally effective in reducing PTSD symptomatology. Our specific hypotheses are as follows:

1. Cognitive-Behavioral Couples Therapy (CBCT) and Prolonged Exposure (PE) will be equally effective in reducing PTSD symptoms in a sample of OEF/OIF/OND Veterans, as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist - Stressor Specific Version (PCL-S).

2. CBCT for PTSD will be more effective than PE in improving relationship distress in a sample of OEF/OIF/OND Veterans and their partners, as measured by the Couples Satisfaction Index.

3. CBCT for PTSD will have significantly greater impact than PE on measures of relationship functioning (e.g., intimacy, conflict, aggression) in a sample of OEF/OIF/OND Veterans and their partners.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • 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.

Exclusion Criteria:

• • 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marital Relationship
• PTSD
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• CBCT for PTSD
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)
• Prolonged Exposure
PE consists of: psychoeducation and some limited distress management training, but emphasizes the role of imaginal and in vivo exposure in treating PTSD.

Locations

Country	Name	City	State
United States	Fort Hood Military Base	Fort Hood	Texas
United States	Brooke Army Medical Center, Fort Sam Houston	Fort Sam Houston	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Ryerson University

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

Monson CM, Guthrie KA, Stevens SP. Cognitive-behavioral couple's treatment for posttraumatic stress disorder. Behavior Therapist. 2003; 26:393-401.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms, as measured by the CAPS and PCL		Post-treatment (approximately 12 weeks)	No
Secondary	PTSD symptoms, as measured by the CAPS and PCL		3, 6 and 12 month follow-ups	No
Secondary	Relationship outcomes, as measured by the Couples Satisfaction Index		Post-treatment (approximately 12 weeks), 3, 6 and 12 month follow-ups	No