Cognitive Behavioral Therapy for Post Traumatic Stress Disorder in Addiction Treatment
NCT ID: NCT01456338
Last Updated: 2011-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2007-06-30
2009-08-31
Brief Summary
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Detailed Description
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Our objective is to test the following specific hypotheses:
CBT for PTSD (plus addiction treatment-as-usual) vs. IAC (plus addiction treatment-as-usual): 1) Reduces PTSD symptoms; 2) Improves addiction treatment retention; and, 3) Reduces substance use and severity. A hierarchy of effects is hypothesized. The target of the CBT is PTSD symptoms, which if reduced, will favorably leverage both treatment retention and substance use, above and beyond the equivalence in type and amount of treatment in both conditions.
This study involves is a two-group repeated measures design. Within the NIDA stage model, it is a randomized, pilot trial with a matched-attention control condition. The investigators plan to examine outcomes associated with the intervention versus control condition among patients receiving outpatient addiction treatment services (intensive outpatient program or methadone maintenance program). The investigators will employ assessments at baseline, during therapy, post-therapy, and three-month follow-up. Eligible subjects will be randomly assigned to the study CBT therapy (plus addiction treatment-as-usual) or the matched attention control condition (individual addiction counseling \[IAC\] plus addiction treatment-as-usual), and all will be followed for the research assessments regardless of whether they drop out of treatment early (whenever possible).
Patients admitted to the participating addiction treatment programs are routinely screened for PTSD using a brief self-report survey, the PTSD Checklist (PCL). These forms are collected by clinical staff of the treatment program and scored for PTSD diagnostic criteria. Patients scoring 44 or greater on the PCL are approached by a clinic staff about potential interest in the study. If they wish to learn more about the study, the research coordinator (an on-site employee) is contacted, a suitable time arranged, and the patient engaged in the process of informed consent.
If consent is granted, the subject completes the baseline assessment. The baseline assessment consists of measures gathered via interview by a member of the research team, self-administered surveys completed directly by the subject, and review of the subject's medical record to extract demographic, substance use, and treatment history information, as well as chart diagnoses.
The interview portion of the assessment consists of:
* Standardized interviews designed to assess PTSD and borderline personality disorder, another commonly associated psychiatric disorder: Clinician Administered PTSD Scale (CAPS) and the SCID-Axis II borderline personality disorder.
* A urine screen and breathalyzer to test for alcohol and other drugs.
* Standardized follow-back method for gathering data on recent alcohol and drug use: Time-line Follow-back Calendar (TLFB).
The self-administered portion of the assessment consists of measures designed to assess:
* Depression (Beck Depression Inventory-II \[BDI-II\])
* Anxiety (Beck Anxiety Inventory \[BAI\])
* Alcohol and drug use, as well as associated problems in other life areas such as medical, employment, legal, social, and psychiatric (Addiction Severity Index \[ASI\])
* Level of risk for HIV (HIV-risk Screening Instrument \[HSI\])
* Treatment utilization (Recent Treatment Survey).
If the subject continues to meet criteria for PTSD (i.e., the CAPS interview confirms diagnosis of DSM-IV PTSD, with symptom severity at 44 or higher), he or she is randomized to receive the study CBT therapy or the control condition (IAC).
At monthly (every four weeks) intervals during the provision of CBT or IAC, the subject will complete the RTS and a trauma event checklist based on the PCL, and will be tested for alcohol use (breathalyzer) and drug use (urine screen). The subject will also complete the Working Alliance Inventory (WAI - client version) at the first monthly assessment only.
Upon completion of the CBT or IAC, a member of the research team will re-interview the subject. The post-therapy assessment (approx. 3-months post-baseline) will consist of the same measures administered at baseline, with the exception of the borderline personality disorder interview.
The final research assessment is conducted three months after the post-therapy assessment. This assessment will consist of the same measures used at the post-therapy assessment, along with the trauma event checklist (to assess for re-traumatization).
The investigators plan to enroll approximately 100 subjects in the study. Based on our previous data, the investigators expect that 60% of referred subjects will actually meet eligibility criteria, leaving 60 subjects to be randomized (30 to CBT and 30 to IAC). The subject outcome and program experiences with the protocol will be used in planning the subsequent federal grant application for a randomized controlled trial.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Cognitive Behavioral Therapy for PTSD
Individual CBT, approx. 12 sessions, one session per week
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.
Individual Addiction Counseling
Individual therapy, approx. 12 sessions, one session per week
Interventions
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Cognitive Behavioral Therapy for PTSD
Individual CBT, approx. 12 sessions, one session per week
Individual Addiction Counseling
Individual therapy, approx. 12 sessions, one session per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Mark McGovern
Associate Professor of Psychiatry and of Community and Family Medicine
Principal Investigators
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Mark P. McGovern, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Dartmouth-Hitchcock Medical Center
Locations
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Hartford Dispensary
Hartford, Connecticut, United States
Addiction Treatment Program at DHMC
Lebanon, New Hampshire, United States
Farnum Center
Manchester, New Hampshire, United States
WestBridge
Manchester, New Hampshire, United States
Starting Now - Brattleboro Retreat
Brattleboro, Vermont, United States
Quitting Time - Clara Martin Center
Wilder, Vermont, United States
Countries
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Other Identifiers
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5K23DA016574_PILOT
Identifier Type: -
Identifier Source: org_study_id