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Integrated Intervention Post-Sexual Assault

Primary Purpose

Substance Use Disorders, Posttraumatic Stress Disorder, Sexual Assault

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Exposure and Cognitive Behavioral Therapy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Written Exposure and Cognitive Behavioral Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Alcohol Use Disorder symptoms on the Alcohol Use Disorders Identification Test
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Change in Depression Symptoms on The Beck Depression Inventory-II
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.
Change in Anxiety Symptoms on The Beck Anxiety Inventory
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".
Change in Depression Symptoms on The PHQ-9
The Patient Health Questionnaire (PHQ-9) is a widely used self-report measure for symptoms of depression. The PHQ-9 includes 9 self-report items, with total scores ranging from 0 to 27, and takes less than 5-minutes to complete. Scores of 5 (mild), 10 (moderate), 15 (moderately severe), and 20 (severe) are cut-off points.

Full Information

First Posted
January 21, 2021
Last Updated
February 1, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04724746
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 20, 2020 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, Posttraumatic Stress Disorder, Sexual Assault

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Written Exposure and Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure and Cognitive Behavioral Therapy
Intervention Description
Intervention involves writing details about a recent sexual assault and coping skills for substance use.
Primary Outcome Measure Information:
Title
Change in Alcohol Use Disorder symptoms on the Alcohol Use Disorders Identification Test
Description
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.
Time Frame
Baseline and after completion of study visits, approximately six weeks.
Title
Change in Percent Drinking Days on The Time Line Follow-Back
Description
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.
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.
Title
Change in Percent Substance Use Days on The Time Line Follow-Back
Description
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.
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.
Title
Change in number of standard drinks per drinking day on The Time Line Follow-Back
Description
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.
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.
Title
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
Description
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.
Time Frame
: Baseline and after completion of study visits, approximately six weeks.
Title
Change in Posttraumatic Stress Disorder Symptoms on The Clinician-Administered Posttraumatic Stress Disorder Scale for the Diagnostic and Statistical Manual of Mental Disorders
Description
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.
Time Frame
Baseline and after completion of study visits, approximately six weeks.
Secondary Outcome Measure Information:
Title
Change in Depression Symptoms on The Beck Depression Inventory-II
Description
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.
Time Frame
Baseline and after completion of study visits, approximately six weeks.
Title
Change in Anxiety Symptoms on The Beck Anxiety Inventory
Description
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".
Time Frame
Baseline and after completion of study visits, approximately six weeks.
Title
Change in Depression Symptoms on The PHQ-9
Description
The Patient Health Questionnaire (PHQ-9) is a widely used self-report measure for symptoms of depression. The PHQ-9 includes 9 self-report items, with total scores ranging from 0 to 27, and takes less than 5-minutes to complete. Scores of 5 (mild), 10 (moderate), 15 (moderately severe), and 20 (severe) are cut-off points.
Time Frame
Baseline and after completion of study visits, approximately six weeks.

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women are eligible
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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 Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Hahn, PhD
Phone
2622972979
Email
hahnc@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine K Hahn, PhD
Phone
262-297-2979
Email
hahnc@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Integrated Intervention Post-Sexual Assault

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