Integrated Intervention Post-Sexual Assault

Study Overview
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Brief Summary
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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.

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

Conditions
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Substance Use Disorders, Posttraumatic Stress Disorder, Sexual Assault

Intervention / Treatment
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* Behavioral: Written Exposure and Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Written Exposure and Cognitive Behavioral Therapy<br>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<br>* Intervention involves writing details about a recent sexual assault and coping skills for substance use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and after completion of study visits, approximately six weeks. | 
| 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 study completion 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 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. |