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Early Intervention Following Sexual Assault

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ClinicalTrials.gov Identifier: NCT04582695
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : January 7, 2021
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Christine Hahn, Medical University of South Carolina

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.

Condition or disease Intervention/treatment Phase
Ptsd Alcohol Use Disorder Sexual Assault and Rape Behavioral: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder Behavioral: Written Exposure Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Early Intervention for Alcohol Use Disorder and Posttraumatic Stress Disorder Following Sexual Assault
Actual Study Start Date : December 15, 2020
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : February 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Written Exposure Therapy Behavioral: Written Exposure Therapy
Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.

Experimental: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder Behavioral: Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder
Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).




Primary Outcome Measures :
  1. Change in Alcohol Use Disorder symptoms on the Alcohol Use Disorders Identification Test [ Time Frame: Baseline and after completion of study visits, approximately six weeks. ]
    The 10-item Alcohol Use Disorders Identification Test is a screening tool that will be used to gather data about participants' alcohol consumption, drinking behaviors, and alcohol related-problems. This screening measure is rated on a 5-point scale and based in terms of standard alcoholic drinks. A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, is likely to indicate alcohol dependence.

  2. Change in Percent Drinking Days on The Time Line Follow-Back [ Time Frame: 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. ]
    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.

  3. Change in number of standard drinks per drinking day on The Time Line Follow-Back [ Time Frame: 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. ]
    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.

  4. Change in Posttraumatic Stress Disorder Symptoms on The Posttraumatic Stress Disorder Checklist for Diagnostic and Statistical Manual of Mental Disorders (PCL-5) [ Time Frame: Baseline and after completion of study visits, approximately six weeks. ]
    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.

  5. Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders [ Time Frame: Baseline and after completion of study visits, approximately six weeks. ]
    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.


Secondary Outcome Measures :
  1. Change in Depression Symptoms on The Beck Depression Inventory-II [ Time Frame: Baseline and after completion of study visits, approximately six weeks. ]
    The Beck Depression Inventory-II (BDI-II) is a widely used self-report measure for attitudes and symptoms of depression. The BDI-II includes 21 self-report items and takes approximately 5-minutes to complete. Each item is rated on a 4-point scale ranging from 0 to 3. The maximum total score is 63. A total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

  2. Change in Anxiety Symptoms on The Beck Anxiety Inventory [ Time Frame: Baseline and after completion of study visits, approximately six weeks. ]
    The Beck Anxiety Inventory (BAI) assesses symptoms of anxiety via 21-item self-report. The BAI reliability discriminates anxiety-disordered from non-anxiety disordered patients and demonstrates excellent convergence with related anxiety scales. The values for each item are summed yielding an overall or total score for all 21 symptoms that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe".

  3. Change in Percent Days Using Substances on The Time Line Follow-Back [ Time Frame: 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. ]
    The Time Line Follow-Back will be used to assess illicit substance use in the past 30-days. This calendar-assisted interview yielded estimates in terms of self-report of substance use by using a calendar and other memory prompts to stimulate recall.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women only
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female; any race or ethnicity; age 18 to 65 years old.
  • Sexual assault that occurred within the past six weeks.
  • 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 33 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. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582695


Contacts
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Contact: Christine K Hahn, PhD 262 297 2979 hahnc@musc.edu
Contact: Sudie Back, PhD 843-792-9383 backs@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Christine K Hahn, PhD    262-297-2979    hahnc@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Responsible Party: Christine Hahn, Research Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04582695    
Other Study ID Numbers: 00099114
1K23AA028055 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders