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Brief Restructuring Intervention Following Trauma Exposure (BRITE)

Primary Purpose

Posttraumatic Stress Disorder, Alcohol Use Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Sexual assault, Posttraumatic Stress Disorder, Alcohol use, Cognitive therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Brief Cognitive Intervention

Assessment Only

Arm Description

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

Assessment session followed by weekly completion of assessment measures

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Drinking Inventory of Consequences (DrInC)
The DrInC will be included to assess alcohol use consequences.

Full Information

First Posted
June 17, 2016
Last Updated
June 25, 2020
Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02808468
Brief Title
Brief Restructuring Intervention Following Trauma Exposure
Acronym
BRITE
Official Title
Developing a Brief Early Cognitive Intervention for PTSD and Alcohol Misuse
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2015 (undefined)
Primary Completion Date
February 2020 (Actual)
Study Completion Date
February 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Alcohol Use Disorders
Keywords
Sexual assault, Posttraumatic Stress Disorder, Alcohol use, Cognitive therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Cognitive Intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Assessment Only
Arm Type
No Intervention
Arm Description
Assessment session followed by weekly completion of assessment measures
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Therapy
Intervention Description
Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
Primary Outcome Measure Information:
Title
Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)
Description
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
Time Frame
12 weeks
Title
Timeline Followback (TLFB)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Drinking Inventory of Consequences (DrInC)
Description
The DrInC will be included to assess alcohol use consequences.
Time Frame
12 weeks

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Must identify as female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Bedard-Gilligan, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Brief Restructuring Intervention Following Trauma Exposure

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