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| ID | Type | Description | Link |
|---|---|---|---|
| CX001967-01 | Other Grant/Funding Number | Department of Veterans Affairs |
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The goal of this study is to examine whether a brief, exposure-based treatment (Written Exposure Therapy) approach is just as effective in the treatment of posttraumatic stress disorder (PTSD) compared with a more commonly used time-intensive approach called Prolonged Exposure. One hundred and fifty Veterans diagnosed with PTSD will be randomly assigned to either Written Exposure therapy or Prolonged Exposure. Veteran participants will be assessed at pre-treatment, and 10-, 20-, and 30- weeks post first treatment session. Primary outcome measure will be PTSD symptom severity. The secondary outcome measure will be quality of life. In addition, treatment dropout during the first five sessions will be examined. WET is expected to have a lower treatment dropout rate relative to PE.
Although Written Exposure Therapy (WET) is listed in the upcoming VA/DoD PTSD Practice Guidelines as an evidence-based, recommended PTSD treatment, there are limited data supporting the use of WET with Veterans suffering from PTSD. Additional research is needed to support the use of WET for the treatment of Veterans diagnosed with PTSD. The goal of this study is to investigate whether WET is non-inferior in the treatment of PTSD in a sample of Veterans diagnosed with PTSD. Men and women Veterans diagnosed with PTSD will be randomly assigned to either WET (n = 88) or Prolonged Exposure (PE; n = 90). PTSD symptom severity will serve as the primary outcome. Quality of life will serve as a secondary outcome measure. Assessments will be conducted by independent evaluators at baseline, 10-, 20-, and 20-week post first treatment session. WET is expected to be non-inferior to PE in reducing PTSD symptom severity and functioning. In addition, WET is expected to have significantly lower treatment dropout rate relative to the first five sessions of PE (i.e., better treatment engagement). If WET is found to be non-inferior to the more time intensive PE treatment then the VA will have evidence to support the use of a brief PTSD treatment, which will assist in addressing the high demand for PTSD clinical services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| written exposure therapy | Experimental | The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. |
|
| Prolonged Exposure | Active Comparator | Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trauma-focused treatment | Behavioral | cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered PTSD Scale for Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) | The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity. | change score baseline to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life BREF | The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete. Total score 0-100, with higher scores indicate greater quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
Current engagement psychosocial treatment for PTSD
Current diagnosis of substance dependence
Current psychosis or unstable bipolar disorder diagnosis
High suicidal risk
Significant cognitive impairment (assessed with the Montreal Cognitive Assessment [MoCA] and clinical judgment)
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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 | 02130-4817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37610727 | Derived | Sloan DM, Marx BP, Acierno R, Messina M, Muzzy W, Gallagher MW, Litwack S, Sloan C. Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1093-1100. doi: 10.1001/jamapsychiatry.2023.2810. |
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Datasets meeting VA standards for disclosure to the public will be made available within 1 year after publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information (PHI). Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by Office of Research and Development (ORD). Those requesting data will be asked to sign a Letter of Agreement.
one year
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| ID | Title | Description |
|---|---|---|
| FG000 | Written Exposure Therapy | The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
| FG001 | Prolonged Exposure | Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Written Exposure Therapy | The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Diagnostic (CAPS-5) and Statistical Manual of Mental Disorders (DSM-5) | The CAPS-5 is a structured diagnostic interview and the gold standard for assessing the DSM-5 symptoms of PTSD (American Psychiatric Association, 2013). The scale also assesses social and occupational functioning, dissociation symptoms, and the validity of symptom reports. The CAPS-5 uses a single 5-point ordinal rating scale to measure symptom severity. Symptom severity ratings combine information about symptom frequency and intensity obtained by the interviewer. Psychometric properties indicate high criterion and construct validity and high agreement with a self-report measure of PTSD (Weathers et al., 2018). The CAPS-5 requires approximately 40 minutes to administer. Scores can range from 0-80, with higher scores indicating greater severity. | Posted | Mean | 95% Confidence Interval | CAPS-5 total score | change score baseline to 20 weeks |
|
30 weeks
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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 | The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant. trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| medical hospitalization | Surgical and medical procedures | Systematic Assessment | hospitalization due to medical surgery unrelated to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| contracted COVID-19 | Immune system disorders | Systematic Assessment | physical symptoms from contracting COVID-19 |
Study focused on veteran participants and thus findings may not generalize to the general population. The study also primarily took place during COVID-19 global pandemic, including the height of the initial lockdown, which was a period of increased stress and anxiety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Denise Sloan | National Center for PTSD at 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, 2022 | Oct 12, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2021 | Jan 6, 2023 | ICF_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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The study is a non-inferiority design to examine if a brief intervention for PTSD is non-inferior to a more time-intensive intervention.
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Assessors will be unaware of participant conditions. Assessors will not have access to any study materials in which unmasking could occur. Participants will be instructed to not reveal their treatment condition to the assessors.
| change score baseline to 20 weeks |
| Ralph H. Johnson VA Medical Center, Charleston, SC |
| Charleston |
| South Carolina |
| 29401-5799 |
| United States |
| William S. Middleton Memorial Veterans Hospital, Madison, WI | Madison | Wisconsin | 53705 | United States |
| BG001 | Prolonged Exposure | Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
The WET condition consists of 5-7 weekly treatment sessions, with the first session lasting 1 hour and each subsequent session lasting approximately 40 minutes. The first session consists of education about common trauma reactions and the WET rationale. The participant is then given general instructions for completing the trauma narratives and specific instructions for completing the first 30-minute narrative writing session. All WET sessions begin with the therapist reading the specific writing instructions, clarifying any questions the person has, and leaving the instructions with the participant during the 30-minute writing session. Writing instructions begin with a focus on the details of the trauma and then shift to the meaning of the trauma event. After 30 minutes of writing, the therapist stops the writing and conducts a 5-10 minute check-in regarding how the writing session went for the participant.
trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
| OG001 | Prolonged Exposure | Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. |
|
|
| Secondary | World Health Organization Quality of Life BREF | The World Health Organization Quality of Life BREF (WHOQOL-BREF; WHO, 1998) instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that is more convenient for use in large research studies or clinical trials. This measure requires 5-10 minutes to complete. Total score 0-100, with higher scores indicate greater quality of life. | The sample size is substantially less than the number randomized because the self-report measure was mailed to the study team due to COVID-19 pandemic and response rate for self-report measures was much lower than clinician-administered interviews (i.e., CAPS-5). Accordingly, the planned analysis is not conducted as it is underpowered. | Posted | Mean | Standard Deviation | change score; score on a scale | change score baseline to 20 weeks |
|
|
|
| 0 |
| 88 |
| 4 |
| 88 |
| 6 |
| 88 |
| EG001 | Prolonged Exposure | Prolonged Exposure (PE) is a 8-15, 90 minute trauma-focused treatment which consists of imaginal and in vivo exposures trauma-focused treatment: cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory. | 0 | 90 | 7 | 90 | 5 | 90 |
|
| medical hospitalization | Infections and infestations | Systematic Assessment | hospitalized due to severe dehydration due to vomiting during flu. |
|
| psychiatric hospitalization | Psychiatric disorders | Systematic Assessment | increased suicidal risk |
|
|
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