Status:
COMPLETED
Integrated Intervention Post-Sexual Assault
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Substance Use Disorders
Posttraumatic Stress Disorder
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- Female; any race or ethnicity; age 18 to 65 years old.
- Sexual assault that occurred within the past ten weeks.
- Subjects must be able to comprehend English.
- Report a minimum of two substance use disorder symptoms
- A minimum of one symptom of each cluster of Posttraumatic Stress Disorder
- 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
- Must consent to complete all treatment and follow-up visits.
Exclusion
- Lack of any memory of the sexual assault
- Women who are menopausal
- 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.
- 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.
- Individuals considered an immediate suicide risk, with current suicidal ideation and intent. These individuals will be referred directly for treatment.
- Individuals on psychotropic medications must be stabilized on it for at least two weeks prior to beginning the study.
- Any other medical or psychiatric conditions that the investigators believe may compromise the individual's ability to safely participate in the study.
Key Trial Info
Start Date :
February 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04724746
Start Date
February 20 2020
End Date
August 8 2022
Last Update
February 2 2024
Active Locations (1)
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1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425