Posttraumatic Stress DisorderNCT01286415
Group Cognitive Processing Therapy for Combat-related Posttraumatic Stress Disorder (PTSD)
A study testing Group Cognitive Processing Therapy-Cognitive Only and Group Present Centered Therapy in people with Posttraumatic Stress Disorder, run by VA Boston Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that… 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 Group Present Centered Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2013
- 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.
About this study
Official title: Group Cognitive Processing Therapy for Combat-related PTSD
The purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format.
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 other forms of group treatment. The public policy implications of the results of this trial are significant. If group treatment is found to be effective, then group treatment would be a more efficient and cost-effective therapy modality in most cases. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format. One hundred (100) 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 to receive either group PCT or group CPT-C.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Group Cognitive Processing Therapy-Cognitive Only, Group Present Centered Therapy
- 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
Cognitive Processing Therapy (CPT) 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. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.
Group Present Centered TherapyBehavioural
Present Centered Therapy (PCT) is a supportive group intervention typically used within the Department of Veterans Affairs (VA) healthcare systems to address problems of veterans with PTSD (Rosen, et al., 2004). PCT focuses on problem-solving current difficulties that may be related to past traumatic events, but does not address specific memories or cognitions about the trauma. Sessions will be conducted twice weekly for 6 weeks; sessions are 90 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Processing Therapy-Cognitive Only | Experimental | Not described Receives: Behavioral: Group Cognitive Processing Therapy-Cognitive Only |
| Group Present Centered Therapy | Active comparator | Not described Receives: Behavioral: Group Present Centered Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posttraumatic 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)
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.
- First posted31 Jan 2011 (estimated)
- Study startSep 2008
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Boston Healthcare System
- Sponsor type
- US federal agency
- Collaborators
- STRONG STAR Multidisciplinary Research Consortium, The University of Texas Health Science Center at San Antonio
- Responsible party
- Principal investigator, Patricia Resick, Duke University
- Investigators
- Patricia A Resick, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286415
- Sponsor's protocol ID
- W81XWH-08-2-0116
- Status last verified
- Mar 2017
- First submitted
- 26 Jan 2011
- Last updated
- 27 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pruiksma KE, Taylor DJ, Wachen JS, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Borah EV, Dondanville KA, Litz BT, Hembree EA, Resick PA. Residual sleep disturbances following PTSD treatment in active duty military personnel. Psychol Trauma. 2016 Nov;8(6):697-701. doi: 10.1037/tra0000150. Epub 2016 May 30.
PubMed 27243567Dondanville KA, Blankenship AE, Molino A, Resick PA, Wachen JS, Mintz J, Yarvis JS, Litz BT, Borah EV, Roache JD, Young-McCaughan S, Hembree EA, Peterson AL; STRONG STAR Consortium. Qualitative examination of cognitive change during PTSD treatment for active duty service members. Behav Res Ther. 2016 Apr;79:1-6. doi: 10.1016/j.brat.2016.01.003. Epub 2016 Feb 4.
PubMed 26874683Bryan CJ, Clemans TA, Hernandez AM, Mintz J, Peterson AL, Yarvis JS, Resick PA; STRONG STAR Consortium. EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Depress Anxiety. 2016 Jun;33(6):549-57. doi: 10.1002/da.22456. Epub 2015 Dec 4.
PubMed 26636426Resick PA, Wachen JS, Mintz J, Young-McCaughan S, Roache JD, Borah AM, Borah EV, Dondanville KA, Hembree EA, Litz BT, Peterson AL. A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. J Consult Clin Psychol. 2015 Dec;83(6):1058-1068. doi: 10.1037/ccp0000016. Epub 2015 May 4.
PubMed 25939018Miles 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Cognitive Processing Therapy for Combat-related PTSD
- ClinicalTrials.gov ID
- NCT01286415
- Acronym / sponsor ID
- W81XWH-08-2-0116
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Posttraumatic Stress Disorder, Cognitive Processing Therapy, combat, military, CPT, group therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- VA Boston Healthcare SystemUS federal agency
- Collaborators
- STRONG STAR Multidisciplinary Research Consortium, The University of Texas Health Science Center at San Antonio
- Study start
- Sep 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare group-administered Cognitive Processing Therapy-Cognitive-only version (CPT-C), an evidence based treatment for posttraumatic stress disorder (PTSD), to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format.
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 other forms of group treatment. The public policy implications of the results of this trial are significant. If group treatment is found to be effective, then group treatment would be a more efficient and cost-effective therapy modality in most cases. The purpose of this study is to compare group-administered CPT-Cognitive-only version (CPT-C) to Present Centered Therapy (PCT) in order to determine whether the results of CPT exceed those of receiving a therapy that focuses on current problems rather than past trauma in a group format. One hundred (100) 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 to receive either group PCT or group CPT-C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Processing Therapy-Cognitive Only | Experimental | Behavioral: Group Cognitive Processing Therapy-Cognitive Only |
| Group Present Centered Therapy | Active comparator | Behavioral: Group Present Centered Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Cognitive Processing Therapy-Cognitive OnlyCognitive Processing Therapy (CPT) 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. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes. | Behavioural | Group Cognitive Processing Therapy-Cognitive Only |
| Group Present Centered TherapyPresent Centered Therapy (PCT) is a supportive group intervention typically used within the Department of Veterans Affairs (VA) healthcare systems to address problems of veterans with PTSD (Rosen, et al., 2004). PCT focuses on problem-solving current difficulties that may be related to past traumatic events, but does not address specific memories or cognitions about the trauma. Sessions will be conducted twice weekly for 6 weeks; sessions are 90 minutes. | Behavioural | Group Present Centered Therapy |
Primary outcome
Posttraumatic Stress Disorder Checklist-Stressor-specific Version (PCL-S)
Time frame: Baseline, weekly during treatment, posttreatment, 6-month and 12-month follow-up
PCL-S measures symptoms of posttraumatic stress disorder in response to a specific stressor.
1 secondary outcome
Beck Depression Inventory-II
Time frame: Baseline, weekly during treatment, posttreatment, 6-month, and 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Background: PubMed 27243567Pruiksma KE, Taylor DJ, Wachen JS, Mintz J, Young-McCaughan S, Peterson AL, Yarvis JS, Borah EV, Dondanville KA, Litz BT, Hembree EA, Resick PA. Residual sleep disturbances following PTSD treatment in active duty military personnel. Psychol Trauma. 2016 Nov;8(6):697-701. doi: 10.1037/tra0000150. Epub 2016 May 30.
- Background: PubMed 26874683Dondanville KA, Blankenship AE, Molino A, Resick PA, Wachen JS, Mintz J, Yarvis JS, Litz BT, Borah EV, Roache JD, Young-McCaughan S, Hembree EA, Peterson AL; STRONG STAR Consortium. Qualitative examination of cognitive change during PTSD treatment for active duty service members. Behav Res Ther. 2016 Apr;79:1-6. doi: 10.1016/j.brat.2016.01.003. Epub 2016 Feb 4.
- Background: PubMed 26636426Bryan CJ, Clemans TA, Hernandez AM, Mintz J, Peterson AL, Yarvis JS, Resick PA; STRONG STAR Consortium. EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Depress Anxiety. 2016 Jun;33(6):549-57. doi: 10.1002/da.22456. Epub 2015 Dec 4.
- Results publication: PubMed 25939018Resick PA, Wachen JS, Mintz J, Young-McCaughan S, Roache JD, Borah AM, Borah EV, Dondanville KA, Hembree EA, Litz BT, Peterson AL. A randomized clinical trial of group cognitive processing therapy compared with group present-centered therapy for PTSD among active duty military personnel. J Consult Clin Psychol. 2015 Dec;83(6):1058-1068. doi: 10.1037/ccp0000016. Epub 2015 May 4.
- Derived from this study: PubMed 35901423Miles 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia A Resick, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Processing Therapy-Cognitive Only and Group Present Centered Therapy in people with Posttraumatic Stress Disorder, run by VA Boston Healthcare System 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?
Posttraumatic 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 NCT01286415, 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.