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Cognitive Behavioral Therapy (CBT) for Posttraumatic Stress Disorder (PTSD) in Community Addiction Treatment

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. Identifier: NCT01457391
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : February 16, 2015
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark McGovern, Dartmouth-Hitchcock Medical Center

Brief Summary:
The purpose of this phase of the study is to assess the efficacy of CBT for PTSD, as delivered by routine addiction counselors in community treatment programs, and to compare CBT for PTSD with both Individual Addiction Counseling (IAC) and Treatment as Usual (TAU) on the primary outcomes.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Substance-Related Disorders Behavioral: Cognitive Behavioral Therapy Behavioral: Individual Addiction Counseling Behavioral: Treatment-as-usual Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment
Study Start Date : December 2010
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is a non-exposure based manual-guided individual therapy. CBT for PTSD 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) Breathing retraining: A behavioral anxiety reduction skill; and 3) Cognitive restructuring: A cognitive approach and functional analysis of the link among emotions, cognitions and situations.
Behavioral: Cognitive Behavioral Therapy
Individual CBT, approx. 12 sessions, one session per week
Other Names:
  • CBT for PTSD
  • Integrated Cognitive Behavioral Therapy
  • ICBT
  • CBT

Active Comparator: Individual Addiction Counseling
Individual Addiction Counseling (IAC) was adapted from the Individual Drug Counseling (IDC) manual used in the NIDA Cocaine Collaborative Study. IAC is a manual-guided treatment that focuses on substance use and history of use, consequences of use and denial, developing strategies for relapse prevention, and facilitation of connection with peer recovery support groups, specifically twelve step groups. The current adaptation of IAC modified the IDC manual by broadening the focus to include drugs other than cocaine, as well as alcohol.
Behavioral: Individual Addiction Counseling
Individual therapy, approx. 12 sessions, one session per week
Other Name: IAC

Active Comparator: Treatment-as-usual
Treatment-as-usual (TAU) is the typical intensive outpatient (IOP) treatment that the patient would receive ordinarily at the identified addiction treatment program. Each TAU service operates using the American Society of Addiction Medicine criteria for Level II Intensive Outpatient services: 9-12 hours per week; group and individual sessions focused on motivation to address substance use, education about the consequences of substance use on major life areas, education about the disease concept and brain changes associated with addiction, exposure to information about social and family relationships and recovery, and relapse prevention skills.
Behavioral: Treatment-as-usual
Individual or group therapy, approx. 9-12 hours per week, multiple times a week for 2 months
Other Name: TAU

Primary Outcome Measures :
  1. Decrease from baseline in PTSD symptom severity (Clinician Administered PTSD Scale (CAPS) score (30 day)) at 3-months and at 6-months [ Time Frame: Baseline, 3-month, & 6-month follow-ups ]
  2. Decrease from baseline in positive toxicology screens (urine drug screen and breathalyzer) at 3-months and at 6-months [ Time Frame: Baseline, 3-month, & 6-month follow-ups ]
  3. Decrease from baseline in drug and alcohol symptom severity (Addiction Severity Index (ASI)-Self Administered (30 day)) at 3-months and at 6-months [ Time Frame: Baseline, 3-month, & 6-month follow-ups ]
  4. Decrease from baseline in frequency of substance use (Timeline Follow-Back (TLFB) Interview (90 day)) at 3-months and at 6-months [ Time Frame: Baseline, 3-month, & 6-month follow-ups ]

Secondary Outcome Measures :
  1. Difference in treatment retention (continuation and completion of ICBT or IAC) [ Time Frame: From date of treatment commencement until treatment completion, assessed up to approx. 12 weeks ]
  2. Therapist adherence and competence (ICBT or IAC) [ Time Frame: Duration of study intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. At least 18 years old;
  2. Actively enrolled in outpatient addiction services and meets criteria for substance use disorder;
  3. Screened positive for PTSD (results of PCL show a likely Criterion A Traumatic Event and a score equal to or greater than 44);
  4. Willing and able to provide informed consent to participate in the study;
  5. Diagnosis of PTSD verified by the CAPS and total symptom score equal to or greater than 44;

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 to substance intoxication or detoxification and the person is currently stable, they are eligible);
  3. Medical and/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 identifier (NCT number): NCT01457391

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United States, Vermont
Central Vermont Substance Abuse Services
Berlin, Vermont, United States, 05601
Brattleboro Retreat
Brattleboro, Vermont, United States, 05762
Howard Center
Burlington, Vermont, United States, 05401
Evergreen - Rutland Mental Health
Rutland, Vermont, United States, 05701
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute on Drug Abuse (NIDA)
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Principal Investigator: Mark P. McGovern, Ph.D. Geisel School of Medicine at Dartmouth College

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mark McGovern, Professor of Psychiatry and of Community and Family Medicine, Dartmouth-Hitchcock Medical Center Identifier: NCT01457391     History of Changes
Other Study ID Numbers: 5R01DA027650 ( U.S. NIH Grant/Contract )
5R01DA027650 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2011    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Mark McGovern, Dartmouth-Hitchcock Medical Center:
cognitive behavioral therapy
posttraumatic stress disorder (PTSD)
Additional relevant MeSH terms:
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Substance-Related Disorders
Stress Disorders, Traumatic
Behavior, Addictive
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Compulsive Behavior
Impulsive Behavior
Chemically-Induced Disorders