Posttraumatic Stress Disorder Clinical Trial
— BRITEOfficial title:
Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
Verified date | June 2020 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The broad aim of this study is to develop and test a brief intervention that can be implemented in the immediate weeks following sexual assault to decrease likelihood of developing posttraumatic stress disorder (PTSD) or alcohol misuse. The first phase of the study will enroll 6 women to complete a brief, cognitive therapy protocol and provide feedback on the intervention (open trial). The second phase of the study will recruit 76 women to complete either the intervention (38 women) or assessment only (38 women) to test the effects of the intervention on both PTSD symptoms and alcohol use behavior as compared to natural recovery following assault.
Status | Completed |
Enrollment | 63 |
Est. completion date | February 2020 |
Est. primary completion date | February 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Identifies as female - Age > 18 years - 2-10 weeks post sexual assault - PTSD symptoms related to recent sexual assault, specifically defined as a minimum of 1 reexperiencing, 1 avoidance, 2 negative alterations in mood/cognition, or 2 hyperarousal symptoms - Drinking more than 3 drinks on one occasion in the last month and at least two reported negative consequences of alcohol use - Capacity to provide informed consent - English fluency - No planned absences that they would be unable to complete 5 weeks of assessments and coaching calls - Access to a telephone. Exclusion Criteria: - Acutely suicidal with intent/plan - Exhibit current psychosis - Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT) |
Country | Name | City | State |
---|---|---|---|
United States | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) | The PSS-I assesses symptoms of PTSD as defined by the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) and is administered at baseline and 3 month follow up to assess change in PTSD symptoms | 12 weeks | |
Primary | Timeline Followback (TLFB) | The TLFB uses a calendar method to assess drinking frequency and quantity and will be administered at baseline and 3 month follow up to assess for change in drinking behavior. | 12 weeks | |
Secondary | Drinking Inventory of Consequences (DrInC) | The DrInC will be included to assess alcohol use consequences. | 12 weeks |
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