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| Name | Class |
|---|---|
| University of Texas | OTHER |
| United States Department of Defense | FED |
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The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.
The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Written exposure therapy | Experimental | 5 sessions of imaginal exposure therapy. |
|
| CPT, cognitive only | Active Comparator | 12 sessions of cognitive therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| written exposure therapy | Behavioral | five sessions of writing about traumatic experience. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale, 5 (CAPS-5) | The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure. | Change from baseline to 10-, 20-, 30-weeks post first treatment session |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Denise Sloan, Ph.D. | Boston VA Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ft. Hood | Killeen | Texas | United States | |||
| University of Texas Health Science Center, San Antonio |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35015065 | Background | Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911. | |
| 31890987 |
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Data will be made available upon written request to the PI.
12 months after publication of the primary outcomes.
Written request to the PI describing rationale for why data is needed and what will be done with data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Written Exposure Therapy | 5 sessions of imaginal exposure therapy. written exposure therapy: five sessions of writing about traumatic experience. |
| FG001 | CPT, Cognitive Only | 12 sessions of cognitive therapy. CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Written Exposure Therapy | 5 sessions of imaginal exposure therapy. written exposure therapy: five sessions of writing about traumatic experience. |
| BG001 | CPT, Cognitive Only |
| 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, 5 (CAPS-5) | The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure. | Non-inferiority margin | Posted | Mean | Standard Error | score on a scale | Change from baseline to 10-, 20-, 30-weeks post first treatment session |
|
6 months.
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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 | Written Exposure Therapy | 5 sessions of imaginal exposure therapy. written exposure therapy: five sessions of writing about traumatic experience. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | admitted to psychiatric unit due to suicidality |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| increase in anxiety symptoms | Psychiatric disorders | Systematic Assessment |
Participants who dropped out prematurely of treatment were less likely to return for subsequent assessments.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise Sloan, Professor of Psychiatry | VA Boston Healthcare System & Boston University School of Medicine | 857-364-6333 | dsloan@bu.edu |
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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 | Feb 26, 2020 | Mar 3, 2022 | 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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| ID | Term |
|---|---|
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
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| CPT, cognitive only | Behavioral | 12 sessions of cognitive therapy related to traumatic experience. |
|
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| Background |
| Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Contemp Clin Trials Commun. 2019 Dec 10;17:100507. doi: 10.1016/j.conctc.2019.100507. eCollection 2020 Mar. |
12 sessions of cognitive therapy.
CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| CPT, Cognitive Only |
12 sessions of cognitive therapy. CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience. |
|
|
| 0 |
| 85 |
| 1 |
| 85 |
| 6 |
| 85 |
| EG001 | CPT, Cognitive Only | 12 sessions of cognitive therapy. CPT, cognitive only: 12 sessions of cognitive therapy related to traumatic experience. | 0 | 84 | 1 | 84 | 7 | 84 |
|
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