N/A
N=57
Brief Restructuring Intervention Following Trauma Exposure
Posttraumatic Stress Disorder · Alcohol Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02808468 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) — 11.4; 22.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Brief Cognitive Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) |
11.4; 22.1 | — |
| PRIMARY Timeline Followback Heavy Episodic Drinking Episodes |
2.2; 3.7 | — |
| SECONDARY Drinking Inventory of Consequences (DrInC) |
7.4; 19.8 | — |
Summary
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02808468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.