Brief Restructuring Intervention Following Trauma Exposure

NCT ID: NCT02808468

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2020-02-29

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.

Conditions

Posttraumatic Stress Disorder; Alcohol Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Brief Cognitive Intervention

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

Group Type: ACTIVE_COMPARATOR

Brief Cognitive Therapy

Intervention Type: BEHAVIORAL

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

Assessment Only

Assessment session followed by weekly completion of assessment measures

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Brief Cognitive Therapy

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Michele Bedard-Gilligan

Assistant Professor, Medicine: Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michele Bedard-Gilligan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40925075 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37795783 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R34AA022966-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00003232

Identifier Type: -

Identifier Source: org_study_id