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

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ClinicalTrials.gov Identifier: NCT01457404
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : October 26, 2015
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

Brief Summary:
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 or disease Intervention/treatment Phase
Stress Disorder, Post-Traumatic Substance-Related Disorders Behavioral: Integrated Cognitive Behavioral Therapy Behavioral: Treatment-as-usual Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Integrated Cognitive Behavioral Therapy for Co-Occurring PTSD and Substance Use Disorders
Study Start Date : February 2011
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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): NCT01457404


Locations
United States, Rhode Island
Providence Veterans Affairs Medical Center (PVAMC)
Providence, Rhode Island, United States, 02908
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

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: 5R01DA030102 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

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

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