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

Sponsor

VA Boston Healthcare System (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT01274741

Collaborator

(none)

Enrollment

Location

Arms

49.9

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Substance Use Disorder Alcohol Use Disorder	Behavioral: Creating Change (CC) Behavioral: Seeking Safety (SS)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Seeking Safety (SS) 17 sessions of present-focused therapy Seeking Safety	Behavioral: Seeking Safety (SS) 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.
Experimental: Creating Change (CC) 17 sessions of past-focused Creating Change	Behavioral: Creating Change (CC) 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.

Arm

Intervention/Treatment

Active Comparator: Seeking Safety (SS)

17 sessions of present-focused therapy Seeking Safety

Behavioral: Seeking Safety (SS)

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.

Experimental: Creating Change (CC)

17 sessions of past-focused Creating Change

Behavioral: Creating Change (CC)

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.

Outcome Measures

Primary Outcome Measures

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 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 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 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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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