Present- Versus Past-focused Therapy for PTSD and Substance Use Disorder

Study Overview
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Brief Summary
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This study compares Creating Change, a new past-focused behavioral therapy for posttraumatic stress disorder (PTSD)/substance use disorder (SUD), to Seeking Safety, an evidence-based present-focused behavioral therapy for PTSD/SUD.

Detailed Description
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This study evaluates a new behavioral therapy model, Creating Change (CC) for PTSD/SUD. CC helps clients explore the past as a step in their recovery process. It has major public health relevance in that it is a low-cost, flexible model designed for all trauma and substance abuse types, both genders, and all clinical settings. It has particular relevance for VA in that many veterans suffer from PTSD and SUD. The new model demonstrated positive results in two pilot studies.

Official Title
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Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder

Conditions
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Posttraumatic Stress Disorder, Substance Use Disorder, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Creating Change (CC)
* Behavioral: Seeking Safety (SS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meet Diagnostic and Statistical Manual (DSM-IV) criteria for current PTSD and current substance use disorder Have used a substance in the 60 days prior to intake Outpatient Plan to stay in Boston for the next 6 months If on psychiatric medication, are on a stable regimen for at least 4 weeks prior to participation in the study Have a stable mailing address and live nearby enough to come to VA Boston for treatment Able to sign informed consent Willing to participate in all assessments and urine testing Willing to provide a release of information for study staff to contact treaters as needed for clinical concerns Exclusion Criteria: Any current acute medical condition that would either interfere with the patient's ability to attend treatment, or would be of such severity as to affect the patient's psychological functioning Current bipolar I disorder, schizophrenia or other psychotic disorders, mental retardation, or organic mental disorder Any obvious clinical sign that the patient is not sufficiently stable to participate in the treatment, or notification by the patient's primary providers that participation would be contraindicated Dangerousness that would present a threat to staff or patients (e.g., history of assault within the past 6 months) The patient is mandated to treatment

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

Sexes Eligible for Study
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All

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Seeking Safety (SS)<br>17 sessions of present-focused therapy Seeking Safety | Behavioral: Seeking Safety (SS)<br>* Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD. It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders. In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.<br>|
| Experimental: Creating Change (CC)<br>17 sessions of past-focused Creating Change | Behavioral: Creating Change (CC)<br>* Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format. The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup | PTSD symptoms assessed via self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup | PTSD diagnosis as assessed by a trained interviewer | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup | Alcohol use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup. | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup | Drug use and associated problems as measured by blinded-interviewer measure Composite. These outcome variables will be measured at baseline, end of treatment and 3-month followup. Urinanlysis/breathalyzer will be obtained to verify ASI self-report. | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in Brief Symptom Inventory-Global Severity Index - from baseline through end of treatment and 3-month followup | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup: Self-report measure | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 
| Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup | Self-report measure | Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic stress disorder, Substance use disorder, Treatment efficacy, Randomized trial, Trauma, Substance abuse, Addiction