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

January 10, 2011
December 24, 2013
January 2011
June 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01274741 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of Treatment for Posttraumatic Stress Disorder and Substance Use
Pilot Study of an Integrated Exposure-Based Model for Posttraumatic Stress Disorder and Substance Use Disorder

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Posttraumatic Stress Disorder
  • Substance Use Disorder
  • Alcohol Use Disorder
  • 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.
  • 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.
  • 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).
    Intervention: Behavioral: Seeking Safety
  • Experimental: Integrated psychotherapy for PTSD/SUD
    Participants randomly assigned to this arm will receive 17 sessions of Creating Change (described further under Assigned Interventions).
    Intervention: Behavioral: Creating Change (therapy model)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
52
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Lisa Najavits, PhD 617-299-1620 lnajavits@hms.harvard.edu
Contact: Karen Krinsley, PhD 857-364-4132 karen.krinsley@va.gov
United States
 
NCT01274741
SPLA-CX000308-01 (VA CSRD)
Yes
Karen Krinsley, VA Boston Healthcare System
VA Boston Healthcare System
Not Provided
Principal Investigator: Karen E. Krinsley, Ph.D. VA Boston Healthcare System
VA Boston Healthcare System
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP