Brief Restructuring Intervention Following Trauma Exposure

Study Overview
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Brief Summary
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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.

Detailed Description
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Following sexual assault a substantial number of victims will go on to develop posttraumatic stress disorder (PTSD) or alcohol use disorders (AUD), and development of these disorders is costly to both the victim and society as a whole. Intervening early, in the initial weeks following sexual assault, can provide victims with coping strategies that can decrease the likelihood of developing chronic symptoms. Cognitive approaches for treating symptoms of PTSD have strong empirical support with chronic presentation of symptoms. Less is known about effective strategies for intervening acutely following sexual assault. This project is designed to adapt existing empirically supported cognitive treatment principles for both PTSD and AUD symptoms to be delivered acutely (within 10 weeks of assault) in a brief one session format followed by 4 weekly coaching calls. The first 6 participants enrolled will receive the intervention and provide us with feedback on strengths and weaknesses of the protocol to help us improve it (Open Trial). In the next phase, the pilot testing phase, the study will enroll 38 women to complete the one session intervention followed by 4 once per week coaching calls. Participants will then be assessed again for symptoms of PTSD and alcohol use behavior at 3 month follow-up. This brief intervention group will be compared at the 3 month follow-up to a group of 38 women who receive weekly symptom monitoring only. Thus, this research aims to provide information on the efficacy of the intervention compared to the natural recovery process. This research is significant in its potential to use a very brief and easy to access treatment to decrease the development of chronic psychopathology in a high risk group of women.

Official Title
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Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse

Conditions
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Posttraumatic Stress Disorder, Alcohol Use Disorders

Intervention / Treatment
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* Behavioral: Brief Cognitive Therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brief Cognitive Intervention<br>One in person session (90 minutes) of trauma focused cognitive therapy followed by 4 weekly coaching calls (20 minutes each) with the same study therapist | Behavioral: Brief Cognitive Therapy<br>* Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use<br>|
| No Intervention: Assessment Only<br>Assessment session followed by weekly completion of assessment measures | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drinking Inventory of Consequences (DrInC) | The DrInC will be included to assess alcohol use consequences. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual assault, Posttraumatic Stress Disorder, Alcohol use, Cognitive therapy