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Study of Treatment for Posttraumatic Stress Disorder and Substance Use

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01274741
First Posted: January 11, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Karen Krinsley, VA Boston Healthcare System
  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
Posttraumatic Stress Disorder Substance Use Disorder Alcohol Use Disorder Behavioral: Creating Change (therapy model) Behavioral: Seeking Safety

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Karen Krinsley, VA Boston Healthcare System:

Primary Outcome Measures:
  • Change in PTSD Checklist total score - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, 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 [ Time Frame: Baseline, end of treatment, 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 [ Time Frame: Baseline, 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.

  • Change in Addiction Severity Index drug composite score - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, 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.


Secondary Outcome Measures:
  • Change in Quality of Life Satisfaction & Enjoyment Scale - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, 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 [ Time Frame: Baseline, end of treatment, and 3-month followup ]
    Self-report measure

  • Change in Beliefs About Substance Use - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, and 3-month followup ]
    Self-report measure

  • Change in General Self-Efficacy - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, and 3-month followup ]
    Self-report measure

  • Change in Coping Self-Efficacy Scale - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, and 3-month followup ]
    Self-report measure

  • Change in World Assumptions Scale - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, and 3-month followup ]
    Self-report measure

  • Change in Trauma Related Guilt Inventory - from baseline through end of treatment and 3-month followup [ Time Frame: Baseline, end of treatment, and 3-month followup ]
    Self-report measure


Enrollment: 52
Study Start Date: January 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01274741


Locations
United States, Massachusetts
VA Boston Healthcare System - Jamaica Plain Campus
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Boston Healthcare System
Investigators
Principal Investigator: Karen E. Krinsley, Ph.D. VA Boston Healthcare System
  More Information

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)
First Submitted: January 10, 2011
First Posted: January 11, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Substance-Related Disorders
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Chemically-Induced Disorders