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Integrated Cognitive Behavioral Therapy (ICBT) for Posttraumatic Stress Disorder (PTSD) and Substance Use Disorders

This study is currently recruiting participants.
Verified February 2013 by Dartmouth-Hitchcock Medical Center
Sponsor:
Collaborators:
Brown University
Providence VA Medical Center
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark McGovern, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01457404
First received: October 4, 2011
Last updated: February 28, 2013
Last verified: February 2013
History of Changes
  Purpose

The purpose of this study is to assess the safety and practicality, feasibility and efficacy of ICBT for co-occurring PTSD and substance use disorders within the OEF/OIF/OND Veterans population, as delivered by routine clinicians at the Veterans Affairs.


Condition Intervention Phase
Stress Disorder, Post-Traumatic
Substance-Related Disorders
 Behavioral: Integrated Cognitive Behavioral Therapy
Behavioral: Treatment-as-usual
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Integrated Cognitive Behavioral Therapy for Co-Occurring PTSD and Substance Use Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • Decrease from baseline in Clinician Administered PTSD Scale (CAPS) score (PTSD symptom severity) at 3-months and at 6-months [ Time Frame: Baseline, post-treatment, 3 months post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months [ Time Frame: Baseline, post treatment, 3 months post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: February 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated Cognitive Behavioral Therapy
Integrated Cognitive Behavioral Therapy (ICBT) is a non-exposure based, manual-guided individual or group therapy. ICBT consists of 3 learning and skill components designed to improve PTSD symptoms and substance use: 1) Patient education about PTSD and its relation to substance use and treatment; 2) Mindful relaxation: A behavioral anxiety reduction skill including centering and breathing techniques; and 3) Cognitive restructuring/flexible thinking: A cognitive approach and functional analysis of the link among emotions, cognitives and situations.
 Behavioral: Integrated Cognitive Behavioral Therapy
Individual or group ICBT, approx. 12 sessions, one session per week
Other Names:
  • ICBT
  • CBT for PTSD
  • CBT
Active Comparator: Treatment-as-usual
Treatment-as-usual (TAU) is the typical outpatient treatment that patients would receive ordinarily at the PVAMC Substance Abuse Treatment Program (SATP) or PTSD Clinic.
 Behavioral: Treatment-as-usual
Individual or group therapy as usual within the SATP or PTSD clinics at the PVAMC
Other Name: TAU

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. OEF/OIF/OND Veteran status;
  2. Diagnosis of PTSD confirmed by the Clinician Administered PTSD Scale (CAPS) with a total symptom score of 44 or more;
  3. Diagnosis of a substance use disorder (abuse or dependence) and confirmed by the Structured Clinical Interview of DSM-IV Section E (SCID-E);
  4. Willing and able to provide informed consent;

Exclusion Criteria:

  1. Acute psychotic symptoms (however, persons with a psychotic disorder are eligible if their symptoms are stable and they are well connected with appropriate mental health services);
  2. Psychiatric hospitalization or suicide attempt in the past month (however, if the hospitalization or attempt was directly related substance intoxication or detoxification and ther person is currently stable, they are eligible);
  3. Medical or legal situations are unstable such that ability to participate in the full duration of the study seems unlikely.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01457404

Contacts
Contact: Bethany M. Lasko 603-448-0263 Bethany.M.Lasko@Dartmouth.edu
Contact: Andrea L. Meier, M.S. 603-448-0263 andrea.l.meier@dartmouth.edu

Locations
United States, Rhode Island
Providence Veterans Affairs Medical Center (PVAMC) Recruiting
Providence, Rhode Island, United States, 02908
Contact: Erica Eaton, M.A.     401-273-7100 ext 6280     Erica_Eaton@Brown.edu    
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Brown University
Providence VA Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mark P. McGovern, Ph.D. Dartmouth-Hitchcock Medical Center
  More Information

No publications provided

Responsible Party: Mark McGovern, Associate Professor of Psychiatry and of Community and Family Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01457404     History of Changes
Other Study ID Numbers: 5RO1DA030102, 5R01DA030102
Study First Received: October 4, 2011
Last Updated: February 28, 2013
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
integrated cognitive behavioral therapy
cognitive behavioral therapy
addiction
posttraumatic stress disorder (PTSD)

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

ClinicalTrials.gov processed this record on June 18, 2013