Integrated Intervention Post-Sexual Assault

Posttraumatic Stress Disorder Clinical Trial

Official title:

Open Pilot Trial of an Integrated Intervention for Substance Use and Posttraumatic Stress Following Sexual Assault

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04724746
• Other study ID #: Pro0009631
• Status: Completed
• Phase: N/A
• Start date: February 20, 2020
• Est. completion date: August 8, 2022

Study information

• Verified date: January 2024
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 8, 2022
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Posttraumatic Stress Disorder
• Sexual Assault
• Stress Disorders, Post-Traumatic
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Written Exposure and Cognitive Behavioral Therapy
Intervention involves writing details about a recent sexual assault and coping skills for substance use.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.	Baseline and after completion of study visits, approximately six weeks.
Secondary	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".	Baseline and after completion of study visits, approximately six weeks.
Secondary	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.	Baseline and after completion of study visits, approximately six weeks.