PTSDGCBTNCT01544088
Group Treatment for PTSD: A Randomized Clinical Trial With Veterans
A study testing Group Cognitive Behavioral Treatment (GCBT) and Present Centered Group Treatment in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PTSD
- What is being tested?
- Group Cognitive Behavioral Treatment (GCBT) and Present Centered Group Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2012to 1 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more)
- male, Veteran
- be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia
Who cannot join
- a current diagnosis of substance dependence or unstable bipolar disorder
- currently involved in psychosocial treatment for PTSD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Group CBT for Chronic PTSD: RCT With Veterans
The purpose of this study is to examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.
Read the detailed description
The mental health needs of Veterans within the VA Healthcare system are notable. With the substantial increase over the past 10 years in Veterans seeking Posttraumatic Stress Disorder (PTSD) treatment services, the VA system is straining to accommodate these needs, relying heavily on group-based treatments. The proposed research will take the next step in the literature on group psychotherapy for PTSD by examining a group cognitive behavioral treatment (GCBT) program with promising pilot data. This application supports a randomized controlled trial, which will compare GCBT with Supportive Group Psychotherapy (SGP). The trial will involve 196 male Veterans with combat-related PTSD who will be randomly assigned to GCBT (n= 98) or SGP (n =98) to determine efficacy within a naturalistic care environment. Outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Two aims are included, one focusing on outcome with respect to PTSD symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. Data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. The information provided by the proposed project could assist in developing more effective care models for individuals with chronic PTSD from numerous traumatic experiences. Additionally, this project represents an effort to move the literature on group-based treatments for PTSD ahead, through inclusion of advanced methodological and analytic approaches.
- Conditions
- PTSD
- Being tested
- Group Cognitive Behavioral Treatment (GCBT), Present Centered Group Treatment
- Keywords
- randomized controlled trial, PTSD, cognitive behavioral treatment, group treatment
- 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 Behavioral Treatment (GCBT)Behavioural
GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
Present Centered Group TreatmentBehavioural
The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: GCBT | Experimental | Group Cognitive Behavioral treatment (GCBT) Receives: Behavioral: Group Cognitive Behavioral Treatment (GCBT) |
| Arm 2: Group Treatment | Active comparator | Present Centered Group Treatment Receives: Behavioral: Present Centered Group Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity.
Measured: 12 months
Secondary outcomes (3)
Beck Depression Inventory, II (BDI-II)
The BDI is a self-report inventory that indexes depression symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Measured: 12 months
Short-Form Health Survey (SF-36)
The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.
Measured: 12 months
Beck Anxiety Inventory (BAI)
The BAI is a self-report measure of general anxiety symptom severity. Total score range = 0-63; higher scores indicate greater symptom severity.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2012 (estimated)
- Study start1 Jul 2012
- Primary completion23 Aug 2017
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Denise M Sloan, PhD, Principal investigator, VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544088
- Sponsor's protocol ID
- MHBA-015-11F
- Other IDs
- 1I01CX000467-01A1
- Acronym
- GCBT
- Status last verified
- Mar 2020
- First submitted
- 28 Feb 2012
- Last updated
- 23 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available through Freedom of Information Act.
Publications
Sloan DM, Unger W, Lee DJ, Beck JG. A Randomized Controlled Trial of Group Cognitive Behavioral Treatment for Veterans Diagnosed With Chronic Posttraumatic Stress Disorder. J Trauma Stress. 2018 Dec;31(6):886-898. doi: 10.1002/jts.22338. Epub 2018 Nov 29.
PubMed 30499227Sloan DM, Unger W, Gayle Beck J. Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial. Contemp Clin Trials. 2016 Mar;47:123-30. doi: 10.1016/j.cct.2015.12.016. Epub 2015 Dec 21.
PubMed 26718094Marx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.
PubMed 34941354
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group CBT for Chronic PTSD: RCT With Veterans
- ClinicalTrials.gov ID
- NCT01544088
- Acronym / sponsor ID
- GCBT / MHBA-015-11F
- Conditions
- PTSD
- Keywords
- randomized controlled trial, PTSD, cognitive behavioral treatment, group treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2012 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 5 Mar 2012 (estimated)
- Results
- Posted 29 Apr 2019
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 examine whether group cognitive behavioral treatment (GCBT) is efficacious in the treatment of PTSD in a sample of male Veterans. Veterans with a primary diagnosis of chronic PTSD will be randomly assigned to either GCBT or a supportive group treatment condition. Both treatments will consist of 14, weekly sessions. Assessment of PTSD and related symptoms will be conducted at pre-treatment, mid treatment, post-treatment, and 3-, 6-, - and 12-month follow-up.
Detailed description
The mental health needs of Veterans within the VA Healthcare system are notable. With the substantial increase over the past 10 years in Veterans seeking Posttraumatic Stress Disorder (PTSD) treatment services, the VA system is straining to accommodate these needs, relying heavily on group-based treatments. The proposed research will take the next step in the literature on group psychotherapy for PTSD by examining a group cognitive behavioral treatment (GCBT) program with promising pilot data. This application supports a randomized controlled trial, which will compare GCBT with Supportive Group Psychotherapy (SGP). The trial will involve 196 male Veterans with combat-related PTSD who will be randomly assigned to GCBT (n= 98) or SGP (n =98) to determine efficacy within a naturalistic care environment. Outcome data will be collected pre-treatment, mid-treatment, post-treatment, and 3-, 6- and 12-month follow-up. Two aims are included, one focusing on outcome with respect to PTSD symptom severity, the second focusing on treatment generalization to comorbid emotional disorders (major depressive disorder, generalized anxiety disorder, and alcohol abuse), and distress and impairment. Data will be examined using latent growth curve modeling, with emphasis on determining efficacy and effectiveness. The information provided by the proposed project could assist in developing more effective care models for individuals with chronic PTSD from numerous traumatic experiences. Additionally, this project represents an effort to move the literature on group-based treatments for PTSD ahead, through inclusion of advanced methodological and analytic approaches.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: GCBT | Experimental | Behavioral: Group Cognitive Behavioral Treatment (GCBT)Group Cognitive Behavioral treatment (GCBT) |
| Arm 2: Group Treatment | Active comparator | Behavioral: Present Centered Group TreatmentPresent Centered Group Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- primary diagnosis of DSM-IV (American Psychiatric Association, 2000) criteria for chronic, PTSD (symptoms lasting 3 months or more)
- male, Veteran
- be free of psychosis and impaired cognitive function caused by traumatic brain injury or dementia
Key exclusion criteria (2 listed)
- a current diagnosis of substance dependence or unstable bipolar disorder
- currently involved in psychosocial treatment for PTSD
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 Behavioral Treatment (GCBT)GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention. | Behavioural | Arm 1: GCBT |
| Present Centered Group TreatmentThe active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. | Behavioural | Arm 2: Group Treatment |
Primary outcome
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time frame: 12 months
The CAPS-5 is a semi-structured interview to assess presence and severity of PTSD symptoms. The total score on the CAPS will be used as the primary outcome measure in this study. Total score range = 0-80; higher scores indicate greater symptom severity.
3 secondary outcomes
Beck Depression Inventory, II (BDI-II)
Time frame: 12 months
Short-Form Health Survey (SF-36)
Time frame: 12 months
Beck Anxiety Inventory (BAI)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30499227Sloan DM, Unger W, Lee DJ, Beck JG. A Randomized Controlled Trial of Group Cognitive Behavioral Treatment for Veterans Diagnosed With Chronic Posttraumatic Stress Disorder. J Trauma Stress. 2018 Dec;31(6):886-898. doi: 10.1002/jts.22338. Epub 2018 Nov 29.
- Background: PubMed 26718094Sloan DM, Unger W, Gayle Beck J. Cognitive-behavioral group treatment for veterans diagnosed with PTSD: Design of a hybrid efficacy-effectiveness clinical trial. Contemp Clin Trials. 2016 Mar;47:123-30. doi: 10.1016/j.cct.2015.12.016. Epub 2015 Dec 21.
- Derived from this study: PubMed 34941354Marx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.
- Individual participant dataSharing planned: Yes. Data will be made available through Freedom of Information Act.
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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.
Denise M Sloan, PhD principal investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Cognitive Behavioral Treatment (GCBT) and Present Centered Group Treatment in people with PTSD, run by VA Office of Research and Development at 2 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 3 inclusion and 2 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 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) (time frame: 12 months). 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 NCT01544088, which also lists 3 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 23 Mar 2020.