Clinical trial NCT04582695: Early Intervention Following Sexual Assault
Official title: Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ptsd
Alcohol Use Disorder
Sexual Assault and Rape
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2020-10-09
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is for women who have experienced a sexual assault in the past six weeks and use alcohol. The research involves completing a five week behavioral treatment for stress and alcohol use. Participants will complete surveys during visits. Participants may also be asked to complete brief daily assessments on their smart phones.

Detailed description: The primary objective of the proposed Stage IA/IB study is to establish feasibility of an integrated cognitive-behavioral intervention for reducing alcohol use disorder (AUD) and posttraumatic stress disorder (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. Next, a pilot randomized controlled trial will be conducted among 54 recent sexual assault victims to evaluate feasibility and preliminary efficacy in reducing AUD severity and PTSD symptoms. Ecological momentary assessments (EMA) will be used to assess alcohol use, craving, and affect during the five-week treatment phase.

Eligibility criteria: Inclusion Criteria:

* Female; any race or ethnicity; age 18 to 65 years old.
* Sexual assault that occurred within the past 12 months.
* Subjects must be able to comprehend English.
* A score of 3 or greater on the Alcohol Use Disorders Identification Test (AUDIT-C) screen.
* A score of 31 or greater on the Posttraumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders (PCL-5). Subjects may also meet criteria for an alcohol use disorder, previous history of posttraumatic stress disorder, mood disorder (except bipolar affective disorder, see Exclusion Criteria) 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 AUD and PTSD (Norman et al., 2018; Zinzow et al., 2012). Subjects may meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for another substance use disorder if AUD is the primary substance of choice.
* Must consent to complete all treatment and follow-up visits.

Exclusion Criteria:

* Lack of any memory of the sexual assault
* Subjects meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a history of or current psychotic, bipolar, 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 of Alcohol (CIWA). 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.
* Individuals who attempted suicide in the past month. 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.

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 study completion 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 and Statistical Manual of Mental Disorders (PCL-5)
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 Patient Health Questionnaire-9.
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 Percent Days Using Substances 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 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: