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PTSDPhase 3NCT02336971

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

A Phase 3 study testing CBCT for PTSD and Prolonged Exposure in people with PTSD and Marital Relationship, run by Toronto Metropolitan University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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]. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD, Marital Relationship
What is being tested?
CBCT for PTSD and Prolonged Exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
3 sitesUnited States
Study dates
Nov 2011to Aug 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.

Who cannot join

  • • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Fort Hood Military Base

    Fort Hood, Texas, 76544

  • Brooke Army Medical Center, Fort Sam Houston

    Fort Sam Houston, Texas, 78234

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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.

Read the 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:

  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.
Being tested
CBCT for PTSD, Prolonged Exposure
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBCT for PTSDBehavioural

    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 ExposureBehavioural

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

Study groups in NCT02336971
Study groupRoleWhat they receive
CBCT for PTSDExperimentalCBCT 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.
Receives: Behavioral: CBCT for PTSD
Prolonged ExposureExperimentalPE 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.
Receives: Behavioral: Prolonged Exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PTSD symptoms, as measured by the CAPS and PCL

    Measured: Post-treatment (approximately 12 weeks)

Secondary outcomes (2)

  1. PTSD symptoms, as measured by the CAPS and PCL

    Measured: 3, 6 and 12 month follow-ups

  2. Relationship outcomes, as measured by the Couples Satisfaction Index

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2015 (estimated)
  2. Study startNov 2011
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02336971
Sponsor's protocol ID
RyersonU
Status last verified
Oct 2016
First submitted
19 Dec 2014
Last updated
7 Oct 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 1955605

  • 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.

    PubMed 10224729

  • 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.

    PubMed 16287395

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

  • 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.

    PubMed 15462542

  • 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.

    PubMed 15546144

  • 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.

    PubMed 4031230

  • 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. doi: 10.1037//0022-006x.60.6.916.

    PubMed 1460153

  • 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.

    PubMed 10646188

  • 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.

    PubMed 9479678

  • 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.

  • 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.

    PubMed 17805215

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CBCT for PTSD and Prolonged Exposure in people with PTSD and Marital Relationship, run by Toronto Metropolitan University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD symptoms, as measured by the CAPS and PCL (time frame: Post-treatment (approximately 12 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02336971, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2016.

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