Brief Restructuring Intervention Following Trauma Exposure

NCT02808468 | Completed Results

• 2 other identifiers: STUDY000032321R34AA022966-01A1
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Alcohol Use Disorders

Keywords

Sexual assault; Posttraumatic Stress Disorder; Alcohol use; Cognitive therapy

Outcome Measures

Primary Outcomes (2)

• Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I)

  The Posttraumatic Stress Disorder Symptom Scale- Interview Version (PSS-I) assesses severity of symptoms of posttraumatic stress disorder (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. The range for the scale is 0-80 with higher scores representing more severe PTSD symptoms.

  12 weeks

• Timeline Followback Heavy Episodic Drinking Episodes

  The Timeline Followback (TLFB) uses a calendar method with cued recall to assess frequency and quantity of alcoholic beverages consumed. Quantity of drinks are reported per day. Episodes of heavy episodic drinking (4+ drinks per occasion) are counted to calculate the number of HED episodes in the past month. The minimum score possible is 0 for number of HED episodes in the past month and the maximum is 30 (count of days in past 30 days in which HED occurred). Higher numbers indicate more heavy episodic drinking episodes.

  12 weeks

Secondary Outcomes (1)

• Drinking Inventory of Consequences (DrInC)

  12 weeks

Study Arms (2)

Brief Cognitive Intervention

ACTIVE COMPARATOR

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

Assessment Only

NO INTERVENTION

Assessment session followed by weekly completion of assessment measures

Interventions

Brief Cognitive Therapy BEHAVIORAL

Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use

Brief Cognitive Intervention

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Must identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identifies as female
• Age \> 18 years
• weeks post sexual assault
• PTSD symptoms related to recent sexual assault, specifically defined as a minimum of
• 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.

You may not qualify if:

• Acutely suicidal with intent/plan
• Exhibit current psychosis
• Previous non-response to an adequate trial (8 or more sessions) of Cognitive Processing Therapy (CPT)

Sponsors & Collaborators

• University of Washington: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Bedard-Gilligan MA, Stappenbeck CA, Ojalehto HJ, Dworkin ER, Cadigan JM, Simpson T, Kaysen DL. A pilot randomized controlled trial of cognitive restructuring for PTSD and alcohol misuse following recent sexual assault: Initial efficacy and feasibility. Behav Res Ther. 2025 Oct;193:104847. doi: 10.1016/j.brat.2025.104847. Epub 2025 Aug 28.

  PMID: 40925075 DERIVED

• O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.

  PMID: 37795783 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Alcoholism; Alcohol Drinking

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Drinking Behavior; Behavior

Limitations and Caveats

Recruitment was ended before reaching target enrollment due to slower than anticipated recruitment and the COVID-19 pandemic which necessitated pausing all in person research activities at our site. Funding expired during the pandemic and we were not able to resume recruitment.

Results Point of Contact

• Title: Dr. Michele Bedard-Gilligan
• Organization: University of Washington

mab29@uw.edu

206-616-4215

Study Officials

• Michele Bedard-Gilligan, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Medicine: Psychiatry

Study Record Dates

• First Submitted: June 17, 2016
• First Posted: June 21, 2016
• Study Start: March 1, 2015
• Primary Completion: February 1, 2020
• Study Completion: February 1, 2020
• Last Updated: February 26, 2025
• Results First Posted: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)