Clinical trial NCT02808468: Brief Restructuring Intervention Following Trauma Exposure
Official title: Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Alcohol Use Disorders
Keywords: Sexual assault
Posttraumatic Stress Disorder
Alcohol use
Cognitive therapy
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2016-06-21
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

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)

Primary outcomes:
measure: Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
timeFrame: 12 weeks
measure: Timeline Followback Heavy Episodic Drinking Episodes
timeFrame: 12 weeks
Secondary outcomes:
measure: Drinking Inventory of Consequences (DrInC)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Michele Bedard-Gilligan, PhD
role: PRINCIPAL_INVESTIGATOR
References: