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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mark McGovern, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01457391
First received: October 4, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Stage II Efficacy Study of Cognitive Behavioral Therapy for PTSD in Community Addiction Treatment

Resource links provided by NLM:


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, 3-month, & 6-month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in treatment retention between ICBT, IAC and TAU at treatment completion, approx. 12 weeks [ Time Frame: From date of treatment commencement until treatment completion, assessed up to approx. 12 weeks ] [ Designated as safety issue: No ]
  • 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-ups ] [ Designated as safety issue: No ]

Enrollment: 443
Study Start Date: December 2010
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01457391

Locations
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
Investigators
Principal Investigator: Mark P. McGovern, Ph.D. Geisel School of Medicine at Dartmouth College
  More Information

No publications provided

Responsible Party: Mark McGovern, Professor of Psychiatry and of Community and Family Medicine, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01457391     History of Changes
Other Study ID Numbers: 5RO1DA027650, 5R01DA027650
Study First Received: October 4, 2011
Last Updated: April 8, 2014
Health Authority: United States: Federal Government

Keywords provided by Dartmouth-Hitchcock Medical Center:
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
Anxiety Disorders
Mental Disorders
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 30, 2014