Clinical trial NCT04724746: Integrated Intervention Post-Sexual Assault
Official title: Open Pilot Trial of an Integrated Intervention for Substance Use and Posttraumatic Stress Following Sexual Assault
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Posttraumatic Stress Disorder
Sexual Assault
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-01-26
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Percent Drinking Days on The Time Line Follow-Back
timeFrame: Participants will report on drinking during the 30 days prior to initiation of the study, and every day until completion of study visits, approximately six weeks.
measure: Change in Percent Substance Use Days on The Time Line Follow-Back
timeFrame: Participants will report on substance use during the 30 days prior to initiation of the study, and every day until study completion of study visits, approximately six weeks.
measure: Change in number of standard drinks per drinking day on The Time Line Follow-Back
timeFrame: Participants will report on drinking during the 30 days prior to initiation of the study, and ever day until completion of study visits, approximately six weeks.
measure: Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist
timeFrame: : Baseline and after completion of study visits, approximately six weeks.
measure: Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders
timeFrame: Baseline and after completion of study visits, approximately six weeks.
Secondary outcomes:
measure: Change in Depression Symptoms on The Beck Depression Inventory-II
timeFrame: Baseline and after completion of study visits, approximately six weeks.
measure: Change in Anxiety Symptoms on The Beck Anxiety Inventory
timeFrame: Baseline and after completion of study visits, approximately six weeks.
measure: Change in Depression Symptoms on The PHQ-9
timeFrame: Baseline and after completion of study visits, approximately six weeks.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References: