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Posttraumatic Stress DisorderNCT02173561

Group vs. Individual Cognitive Processing Therapy for Combat-related PTSD

A study testing Group Cognitive Processing Therapy-Cognitive Only and Individual Cognitive Processing Therapy-Cognitive Only in people with Posttraumatic Stress Disorder, run by Duke University at 1 site 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

The purpose of this study is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Group Cognitive Processing Therapy-Cognitive Only and Individual Cognitive Processing Therapy-Cognitive Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Jun 2012to Jan 2016
Phase
Interventional
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

  • Adult male and female active duty, activated Reservist, or activated National Guard OIF/OEF military personnel or OIF/OEF veterans seeking treatment for PTSD
  • Diagnosis of PTSD determined by a clinician-administered Posttraumatic Stress Scale (PSSI)
  • Person has 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. The diagnosis of PTSD may be indexed to that event or to another Criterion A event.
  • Be over the age of 18
  • Speak and read English
  • Be stable on any psychotropic medications they may be taking.

Who cannot join

  • Current suicide or homicide risk meriting crisis intervention
  • Active psychosis
  • Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Fort Hood Army Base

    Fort Hood, Texas, 76544

Other trials in United States

About this study

The purpose of this study is to conduct a randomized controlled trial to compare group and individual CPT-C for the treatment of PTSD in OIF/OEF military personnel.

Read the detailed description

Estimates indicate that between 100,000 and 300,000 Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) veterans are at significant risk for chronic post-traumatic stress disorder (PTSD), which can become a chronic disorder that impacts all areas of a person's life. PTSD treatment programs are being developed throughout the Department of Defense (DoD) and the Veterans Affairs (VA), but because of the large number of Service Members returning from deployment with PTSD, it is often necessary to provide psychotherapy in groups. Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, was originally developed as a group-based intervention. However, group-based CPT treatment has never been systematically compared to individual CPT treatment. The public policy implications of the results of this trial are significant. If both treatment formats are equivalent or if group treatment is better, then group treatment would be a more efficient and cost-effective therapy modality in most cases. On the other hand, if individual therapy is found to be superior, the investment of greater resources into individual therapy will be justified in order to provide the most effective treatment for PTSD to military personnel. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to individual CPT-C for the treatment of PTSD in OIF/OEF military personnel. Three hundred (300) adult male and female active-duty OIF/OEF military personnel over 18 years of age will be enrolled into this study. Participants will be randomized between group and individual CPT-C.

Being tested
Group Cognitive Processing Therapy-Cognitive Only, Individual Cognitive Processing Therapy-Cognitive Only
Keywords
Posttraumatic Stress Disorder, Cognitive Processing Therapy, combat, military, CPT, group therapy
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.

  • Group Cognitive Processing Therapy-Cognitive OnlyBehavioural

    Also called Group CPT-C

    Cognitive Processing Therapy-Cognitive Only version (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT-C is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted in groups of 8-12 participants. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.

  • Individual Cognitive Processing Therapy-Cognitive OnlyBehavioural

    Also called Individual CPT-C

    Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for six weeks; each session is 60 minutes.

Study groups in NCT02173561
Study groupRoleWhat they receive
Group Cognitive Processing Therapy-Cognitive OnlyExperimentalNot described
Receives: Behavioral: Group Cognitive Processing Therapy-Cognitive Only
Individual Cognitive Processing Therapy-Cognitive OnlyExperimentalNot described
Receives: Behavioral: Individual Cognitive Processing Therapy-Cognitive Only

What is being measured

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

  1. Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)

    PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor.

    Measured: Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up

Secondary outcomes (1)

  1. Change from baseline in depressive symptoms as measured by the Beck Depression Inventory-II

    The BDI-II is one of the most widely used instruments for measuring the severity of depressive symptoms. It consists of 21 items that assess both affective and somatic symptoms related to depression and depressive disorders. Each item is composed of four statements that reflect symptom severity. The statements are scaled from 0 (no disturbance) to 3 (maximal disturbance). Scores on all items are summed to obtain a total severity score.

    Measured: Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up

Timeline

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

  1. First posted25 Jun 2014 (estimated)
  2. Study startJun 2012
  3. Primary completionJan 2016
  4. Study completionJan 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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02173561
Sponsor's protocol ID
W81XWH-08-2-0116-1
Status last verified
Mar 2017
First submitted
19 Jun 2014
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Resick PA, Wachen JS, Dondanville KA, Pruiksma KE, Yarvis JS, Peterson AL, Mintz J; and the STRONG STAR Consortium; Borah EV, Brundige A, Hembree EA, Litz BT, Roache JD, Young-McCaughan S. Effect of Group vs Individual Cognitive Processing Therapy in Active-Duty Military Seeking Treatment for Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Jan 1;74(1):28-36. doi: 10.1001/jamapsychiatry.2016.2729.

    PubMed 27893032

  • Pruiksma KE, Taylor DJ, Wachen JS, Straud CL, Hale WJ, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Borah EV, Dondanville KA, Litz BT, Resick PA. Self-reported sleep problems in active-duty US Army personnel receiving posttraumatic stress disorder treatment in group or individual formats: secondary analysis of a randomized clinical trial. J Clin Sleep Med. 2023 Aug 1;19(8):1389-1398. doi: 10.5664/jcsm.10584.

    PubMed 36988304

  • Wachen JS, Mintz J, LoSavio ST, Kennedy JE, Hale WJ, Straud CL, Dondanville KA, Moring J, Blankenship AE, Vandiver R, Young-McCaughan S, Yarvis JS, Peterson AL, Resick PA; STRONG STAR Consortium. The impact of prior head injury on outcomes following group and individual cognitive processing therapy among military personnel. J Trauma Stress. 2022 Dec;35(6):1684-1695. doi: 10.1002/jts.22870. Epub 2022 Aug 29.

    PubMed 36039506

  • Miles SR, Hale WJ, Mintz J, Wachen JS, Litz BT, Dondanville KA, Yarvis JS, Hembree EA, Young-McCaughan S, Peterson AL, Resick PA. Hyperarousal symptoms linger after successful PTSD treatment in active duty military. Psychol Trauma. 2023 Nov;15(8):1398-1405. doi: 10.1037/tra0001292. Epub 2022 Jul 28.

    PubMed 35901423

  • Straud CL, Dondanville KA, Hale WJ, Wachen JS, Mintz J, Litz BT, Roache JD, Yarvis JS, Young-McCaughan S, Peterson AL, Resick PA; STRONG STAR Consortium. The Impact of Hazardous Drinking Among Active Duty Military With Posttraumatic Stress Disorder: Does Cognitive Processing Therapy Format Matter? J Trauma Stress. 2021 Feb;34(1):210-220. doi: 10.1002/jts.22609. Epub 2020 Oct 19.

    PubMed 33078467

Questions about this trial

What is this clinical trial studying?

A study testing Group Cognitive Processing Therapy-Cognitive Only and Individual Cognitive Processing Therapy-Cognitive Only in people with Posttraumatic Stress Disorder, run by Duke University at 1 site 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 6 inclusion and 3 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

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?

Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S) (time frame: Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up). 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 NCT02173561, which also lists 5 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 27 Mar 2017.

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