Integrated Intervention Post-Sexual Assault

NCT04724746 | Completed DMC

• 1 other identifier: Pro0009631
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Change in Percent Drinking Days on The Time Line Follow-Back

  The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.

  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.

• Change in Percent Substance Use Days on The Time Line Follow-Back

  The Time Line Follow Back (TLFB) will be used to assess substance use in the past 30-days. This calendar-assisted interview yielded estimates in terms of the amount of substances consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.

  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.

• Change in number of standard drinks per drinking day on The Time Line Follow-Back

  The Time Line Follow Back (TLFB) will be used to assess heavy drinking in the past 30-days and use. This calendar-assisted interview yielded estimates in terms of the number of standard drinks consumed daily in the past 30 days used to obtain retrospective self-report of alcohol use by using a calendar and other memory prompts to stimulate recall.

  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.

• 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

  Participants will be asked to complete the 20-item Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) to measure traumatic stress symptoms corresponding with the Diagnostic and Statistical Manual of Mental Disorders -5 PTSD criteria. Items are rated on a five-point Likert scale ranging from 0 (Not at all) to 4 (Extremely) with higher scores indicating greater traumatic stress symptoms. Total scores will be used.

  : Baseline and after completion of study visits, approximately six weeks.

• Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders

  The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders (CAPS-5) is the gold standard in Posttraumatic Stress Disorder (PTSD) assessment. It is a structured 30-minute interview that can be used to diagnosis PTSD. Items focus on symptom presence, onset and duration of symptoms, subjective distress, impact on functioning, and symptom improvement.

  Baseline and after completion of study visits, approximately six weeks.

Secondary Outcomes (3)

• Change in Depression Symptoms on The Beck Depression Inventory-II

  Baseline and after completion of study visits, approximately six weeks.

• Change in Anxiety Symptoms on The Beck Anxiety Inventory

  Baseline and after completion of study visits, approximately six weeks.

• Change in Depression Symptoms on The PHQ-9

  Baseline and after completion of study visits, approximately six weeks.

Study Arms (1)

Written Exposure and Cognitive Behavioral Therapy

EXPERIMENTAL

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.

Behavioral: Written Exposure and Cognitive Behavioral Therapy

Interventions

Written Exposure and Cognitive Behavioral Therapy BEHAVIORAL

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

Written Exposure and Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Women are eligible
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: February 20, 2020
• Primary Completion: August 8, 2022
• Study Completion: August 8, 2022
• Last Updated: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)