Study of Treatment for Posttraumatic Stress Disorder and Substance Use

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by VA Boston Healthcare System
Sponsor:
Information provided by (Responsible Party):
Karen Krinsley, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT01274741
First received: January 10, 2011
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to determine if an integrated, cognitive-behavioral model of psychotherapy is effective in the treatment of individuals with posttraumatic stress disorder (PTSD) and substance use disorder (SUD) compared to a known evidence-based model for PTSD/SUD.


Condition Intervention Phase
Posttraumatic Stress Disorder
Substance Use Disorder
Alcohol Use Disorder
Behavioral: Creating Change (therapy model)
Behavioral: Seeking Safety
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder

Resource links provided by NLM:


Further study details as provided by VA Boston Healthcare System:

Primary Outcome Measures:
  • Change in substance use from baseline to 3-months post-treatment [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
    Substance use measured via urine drug screens and the Addiction Severity Index Drug Use Composite score. These outcome variables will be measured multiple times between baseline and follow-up (weekly urinalysis, monthly administration of the ASI).

  • Change in PTSD symptoms from baseline to 3 months post-treatment [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
    PTSD symptoms assessed using the PTSD Checklist,a self-report measure, and the Clinician-Administered PTSD Scale. These measures are administered at baseline, end of treatment, and 3-month follow-up.


Secondary Outcome Measures:
  • Change in other forms of psychopathology from baseline to 3 months post-treatment [ Time Frame: 3 months post-treatment ] [ Designated as safety issue: No ]
    Measures include the Brief Symptom Inventory, the Global Assessment of Functioning Scale, and the Social Adjustment Scale--Self-Report. These measures are administered at baseline, end of treatment, and 3-month follow-up.


Estimated Enrollment: 52
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Psychotherapy for PTSD/SUD
Participants randomly assigned to this condition will attend 17 sessions of present focused psychotherapy Seeking Safety (described further under Assigned Interventions).
Behavioral: Seeking Safety
Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy specifically designed for integrated treatment of patients with current PTSD and SUD. It consists of 25 topics evenly divided among cognitive, behavioral, and interpersonal topics. Each topic provides a new theme relevant to both disorders; for this study we will offer 17 of the 25 topics and conduct one topic per session.
Experimental: Integrated psychotherapy for PTSD/SUD
Participants randomly assigned to this arm will receive 17 sessions of Creating Change (described further under Assigned Interventions).
Behavioral: Creating Change (therapy model)
Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study are conducted once per week in hour-long sessions. The treatment focuses on exploring 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.

Detailed Description:

This project is designed to evaluate a new model of psychotherapy that was developed for individuals with PTSD and SUD. The new model helps them to 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 has demonstrated positive results in two pilot studies. If the results of the current study are positive, a larger study could be done for the next stage of scientific testing.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01274741

Contacts
Contact: Lisa Najavits, PhD 617-299-1620 lnajavits@hms.harvard.edu
Contact: Karen Krinsley, PhD 857-364-4132 karen.krinsley@va.gov

Locations
United States, Massachusetts
VA Boston Healthcare System - Jamaica Plain Campus Recruiting
Boston, Massachusetts, United States, 02130
Contact: Lisa Najavits, PhD    617-299-1620    lisa.najavits@va.gov   
Contact: Helen Tretiak-Carmichael, MA    857-364-5311    helen.tretiak-carmichael@va.gov   
Principal Investigator: Karen E. Krinsley, Ph.D.         
Principal Investigator: Lisa M. Najavits, Ph.D.         
Sponsors and Collaborators
VA Boston Healthcare System
Investigators
Principal Investigator: Karen E. Krinsley, Ph.D. VA Boston Healthcare System
  More Information

No publications provided

Responsible Party: Karen Krinsley, PTSD Section Chief, VA Boston Healthcare System
ClinicalTrials.gov Identifier: NCT01274741     History of Changes
Other Study ID Numbers: SPLA-CX000308-01 (VA CSRD)
Study First Received: January 10, 2011
Last Updated: December 24, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by VA Boston Healthcare System:
Posttraumatic stress disorder
Substance use disorder
Treatment efficacy
Randomized trial

Additional relevant MeSH terms:
Alcohol Drinking
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Drinking Behavior
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014