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| ID | Type | Description | Link |
|---|---|---|---|
| 1I01CX000467-01A1 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: GCBT | Experimental | Group Cognitive Behavioral treatment (GCBT) |
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| Arm 2: Group Treatment | Active Comparator | Present Centered Group Treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Cognitive Behavioral Treatment (GCBT) | Behavioral | GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Short-Form Health Survey (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise M Sloan, PhD | VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA | Boston | Massachusetts | 02130 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30499227 | Background | 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. | |
| 26718094 | Background | Sloan 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. |
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Data will be made available through Freedom of Information Act.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group Cognitive Behavioral Treatment (GCBT) | 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. |
| FG001 | Present Centered Group Treatment | Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group Cognitive Behavioral Treatment (GCBT) | 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. |
| BG001 | Present Centered Group Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Primary treatment outcomes were examined using hierarchical linear modeling. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
1 year, 4 months
Adverse events were collected based on participant self-report as well as documentation in the VA electronic medical record. As standard practice, all adverse reports were documented, whether or not they were probably or likely related to study participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Cognitive Behavioral Treatment (GCBT) | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hospitalization due to medical illness | Surgical and medical procedures | Systematic Assessment | Medical hospitalization due to medical/surgical procedures |
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No women veterans were included in the study, therefore findings are not generalizable to women veterans.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Denise Sloan, Ph.D. | VA Boston Healthcare System | (857) 364-6333 | denise.sloan@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2016 | Apr 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Present Centered Group Treatment | Behavioral | The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. |
|
The SF-36 is a measure of functional impairment. Total score range = 0-200; higher scores indicate greater functioning.
| 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. | 12 months |
| Providence VA Medical Center, Providence, RI |
| Providence |
| Rhode Island |
| 02908 |
| United States |
| 34941354 | Derived | Marx 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. |
Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) | Total score range = 0-80; higher scores indicate greater symptom severity | Mean | Standard Deviation | units on a scale |
|
| Beck Depression Inventory, II (BDI-II) | Total score range = 0-63; higher scores indicate greater symptom severity | Mean | Standard Deviation | units on a scale |
|
| Beck Anxiety Inventory (BAI) | Total score range = 0-63; higher scores indicate greater symptom severity | Mean | Standard Deviation | units on a scale |
|
| Short-Form Health Survey (SF-36) | Total score range = 0-200; higher scores indicate greater functioning | Mean | Standard Deviation | units on a scale |
|
Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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|
| 0 |
| 98 |
| 15 |
| 98 |
| 0 |
| 98 |
| EG001 | Present Centered Group Treatment | Present Centered Group Treatment: The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors. | 0 | 100 | 22 | 100 | 0 | 100 |
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| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | hospitalization for substance-use related disorder, a condition that predated study entry. Moreover, hospitalization occurred during the follow up assessment phase of the study. |
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| General disorders | General disorders | Systematic Assessment | hospitalization for general disorders |
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| Uninary disorder | Renal and urinary disorders | Systematic Assessment | hospitalization due to renal or urinary disorder |
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| Infection disease | Infections and infestations | Systematic Assessment | hospitalization due to infectious disease |
|
| GI illness | Gastrointestinal disorders | Systematic Assessment | hospitalization due to GI disorders |
|
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