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Cognitive Behavioral Therapy for Post Traumatic Stress Disorder in 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.
 
ClinicalTrials.gov Identifier: NCT01456338
Recruitment Status : Completed
First Posted : October 20, 2011
Last Update Posted : October 20, 2011
Sponsor:
Collaborator:
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 further assess the efficacy of cognitive behavioral therapy (CBT) for posttraumatic stress disorder (PTSD), as delivered by routine addiction counselors, and to compare CBT for PTSD with individual addiction counseling (IAC) on our primary outcomes.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Substance-Related Disorders Behavioral: Cognitive Behavioral Therapy for PTSD Behavioral: Individual Addiction Counseling Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for PTSD in Addiction Treatment: A Randomized Pilot Trial
Study Start Date : June 2007
Actual Primary Completion Date : April 2009
Actual Study Completion Date : August 2009

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 for PTSD
Individual CBT, approx. 12 sessions, one session per week
Other Names:
  • CBT for PTSD
  • 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




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, 3-month, & 6-month follow-up ]

Secondary Outcome Measures :
  1. Difference in treatment retention between ICBT and IAC at treatment completion, approx. 12 weeks [ Time Frame: From date of treatment commensement until treatment completion, assessed up to 12 weeks ]
  2. Reduction from baseline in substance use severity (Addiction Severity Index [ASI]) at 3-months and at 6-months [ Time Frame: Baseline, 3-month & 6-month follow-up ]


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

Inclusion Criteria:

  1. At least 18 years old;
  2. Actively enrolled in outpatient addiction services and meets criteria for any 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 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): NCT01456338


Locations
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United States, Connecticut
Hartford Dispensary
Hartford, Connecticut, United States, 06120
United States, New Hampshire
Addiction Treatment Program at DHMC
Lebanon, New Hampshire, United States, 03756
Farnum Center
Manchester, New Hampshire, United States, 03101
WestBridge
Manchester, New Hampshire, United States, 03101
United States, Vermont
Starting Now - Brattleboro Retreat
Brattleboro, Vermont, United States, 05301
Quitting Time - Clara Martin Center
Wilder, Vermont, United States, 05088
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Mark P. McGovern, Ph.D. Dartmouth-Hitchcock Medical Center
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Responsible Party: Mark McGovern, Associate Professor of Psychiatry and of Community and Family Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01456338    
Other Study ID Numbers: 5K23DA016574_PILOT
5K23DA016574 ( U.S. NIH Grant/Contract )
First Posted: October 20, 2011    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011
Keywords provided by Mark McGovern, Dartmouth-Hitchcock Medical Center:
cognitive behavior therapy
addiction
posttraumatic stress disorder (PTSD)
Additional relevant MeSH terms:
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Disease
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