Integrated Intervention Post-Sexual Assault

NCT ID: NCT04724746

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2022-08-08

Brief Summary

The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing SUD and PTSD symptoms among women who experienced a sexual assault within the past six weeks. The intervention will be tested in an open label trial to make final modifications to evaluate feasibility, acceptability, and preliminary efficacy of the five to six week integrated intervention with standardized repeated measures during a one-month follow-up.

Conditions

Substance Use Disorders; Posttraumatic Stress Disorder; Sexual Assault

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Written Exposure and Cognitive Behavioral Therapy

Participants receive 5 to 6, 60 minute, sessions of written exposure therapy for posttraumatic stress disorder combined with cognitive behavioral therapy for substance use disorder.

Group Type: EXPERIMENTAL

Written Exposure and Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Intervention involves writing details about a recent sexual assault and coping skills for substance use.

Interventions

Written Exposure and Cognitive Behavioral Therapy

Intervention involves writing details about a recent sexual assault and coping skills for substance use.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Female; any race or ethnicity; age 18 to 65 years old.

2. Sexual assault that occurred within the past ten weeks.

3. Subjects must be able to comprehend English.

4. Report a minimum of two substance use disorder symptoms

5. A minimum of one symptom of each cluster of Posttraumatic Stress Disorder

6. Subjects may also meet criteria for a mood disorder or other anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with substance use disorder and posttraumatic stress disorder

7. Must consent to complete all treatment and follow-up visits.

Exclusion Criteria

1. Lack of any memory of the sexual assault

2. Women who are menopausal

3. Subjects with a history of or current psychotic, manic, dissociative identify disorder, or a current eating disorder, as the study protocol may be therapeutically insufficient.

4. Subjects experiencing significant withdrawal symptoms, as evidence by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA)99 or a positive score of on the Clinical Opiate Withdrawal Scale.100 These subjects will be referred for clinical detoxification and may be re-assessed for study eligibility after medically supervised detoxification has been completed.

5. Individuals considered an immediate suicide risk, with current suicidal ideation and intent. These individuals will be referred directly for treatment.

6. Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.

7. Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Christine Hahn

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

Pro0009631

Identifier Type: -

Identifier Source: org_study_id