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

Not Applicable

Completed

• Conditions: Alcohol Use Disorder; Posttraumatic Stress Disorder; Substance Use Disorder

• Registration Number: NCT01274741
• Lead Sponsor: VA Boston Healthcare System

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-10
• Study First Submitted QC: 2011-01-10
• Study First Posted: 2011-01-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup	PTSD symptoms assessed via self-report measure
Change in Addiction Severity Index alcohol composite score - from baseline through end of treatment and 3-month followup	Baseline, end of treatment (approximately 4 months from baseline), 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.
Change in diagnosis of PTSD on the MINI Neuropsychiatric Interview - from baseline through end of treatment and 3-month followup	Baseline, end of treatment (approximately 4 months from baseline), and 3-month followup	PTSD diagnosis as assessed by a trained interviewer
Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup	Baseline, end of treatment (approximately 4 months from baseline), 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States