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Study of Treatment for Posttraumatic Stress Disorder and Substance Use

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Krinsley, VA Boston Healthcare System
ClinicalTrials.gov Identifier:
NCT01274741
First received: January 10, 2011
Last updated: February 20, 2017
Last verified: February 2017
January 10, 2011
February 20, 2017
January 2011
March 2015   (Final data collection date for primary outcome measure)
  • 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.
  • Change in substance use from baseline to 3-months post-treatment [ Time Frame: 3 months post-treatment ]
    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 ]
    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.
Complete list of historical versions of study NCT01274741 on ClinicalTrials.gov Archive Site
  • 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
Change in other forms of psychopathology from baseline to 3 months post-treatment [ Time Frame: 3 months post-treatment ]
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.
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
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
 
Completed
52
March 2015
March 2015   (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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01274741
SPLA-CX000308-01 (VA CSRD)
Yes
Not Provided
Plan to Share IPD: No
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
February 2017

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