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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written Exposure and Cognitive Behavioral Therapy | Behavioral | Intervention involves writing details about a recent sexual assault and coping skills for substance use. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Women are eligible
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| : 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. |
| 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. |