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

Primary Purpose

PTSD, Marital Relationship

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

CBCT for PTSD

Prolonged Exposure

About this trial

This is an interventional treatment trial for PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Fort Hood Military Base
Brooke Army Medical Center, Fort Sam Houston
University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CBCT for PTSD

Prolonged Exposure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

PTSD symptoms, as measured by the CAPS and PCL

Secondary Outcome Measures

PTSD symptoms, as measured by the CAPS and PCL

Relationship outcomes, as measured by the Couples Satisfaction Index

Full Information

NCT ID

NCT02336971

First Posted

December 19, 2014

Last Updated

October 6, 2016

Sponsor

Toronto Metropolitan University

1. Study Identification

Unique Protocol Identification Number

NCT02336971

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

November 2011 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Toronto Metropolitan University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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: 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). 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD, Marital Relationship

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBCT for PTSD

Arm Type

Experimental

Arm Description

Arm Title

Prolonged Exposure

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CBCT for PTSD

Intervention Description

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)

Intervention Type

Behavioral

Intervention Name(s)

Prolonged Exposure

Intervention Description

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

Primary Outcome Measure Information:

Title

PTSD symptoms, as measured by the CAPS and PCL

Time Frame

Post-treatment (approximately 12 weeks)

Secondary Outcome Measure Information:

Title

PTSD symptoms, as measured by the CAPS and PCL

Time Frame

3, 6 and 12 month follow-ups

Title

Relationship outcomes, as measured by the Couples Satisfaction Index

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Candice M Monson, PhD

Organizational Affiliation

Toronto Metropolitan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Fort Hood Military Base

City

Fort Hood

State/Province

Texas

ZIP/Postal Code

76544

Country

United States

Facility Name

Brooke Army Medical Center, Fort Sam Houston

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

Country

United States

Facility Name

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

1955605

Citation

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Results Reference

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10224729

Citation

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Results Reference

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PubMed Identifier

16287395

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. doi: 10.1037/0022-006X.73.5.953.

Results Reference

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Citation

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

Results Reference

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PubMed Identifier

15462542

Citation

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PubMed Identifier

15546144

Citation

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Results Reference

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PubMed Identifier

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Citation

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Citation

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Citation

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Citation

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Citation

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Citation

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Citation

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

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