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

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

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.

Study Overview

• Status: Completed
• Conditions: Substance Use Disorder; Posttraumatic Stress Disorder; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Seeking Safety (SS); Behavioral: Creating Change (CC)

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02459
      • VA Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: VA Boston Healthcare System
• Investigators: Principal Investigator: Karen E. Krinsley, Ph.D., VA Boston Healthcare System; Principal Investigator: Lisa M Najavits, PhD, VA Boston Healthcare System

Publications and helpful links

General Publications

• Najavits LM, Krinsley K, Waring ME, Gallagher MW, Skidmore C. A Randomized Controlled Trial for Veterans with PTSD and Substance Use Disorder: Creating Change versus Seeking Safety. Subst Use Misuse. 2018 Sep 19;53(11):1788-1800. doi: 10.1080/10826084.2018.1432653. Epub 2018 Feb 20.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: January 10, 2011
• First Submitted That Met QC Criteria: January 10, 2011
• First Posted (Estimate): January 11, 2011

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Addiction; Randomized trial; Trauma; Treatment efficacy; Substance use disorder; Substance abuse; Posttraumatic stress disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Alcohol-Related Disorders; Trauma and Stressor Related Disorders; Substance-Related Disorders; Alcoholism; Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: SPLA-CX000308-01 (VA CSRD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO