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
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorder, Post-Traumatic Substance-Related Disorders||Behavioral: Integrated Cognitive Behavioral Therapy Behavioral: Treatment-as-usual||Phase 3|
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The proposed research will evaluate the safety and practicality, feasibility, and efficacy of a relatively simple, manual guided integrated cognitive behavioral therapy (ICBT). ICBT (a revised edition of what was formerly called cognitive behavioral therapy for posttraumatic stress disorder [CBT for PTSD]) has been designed and developed for delivery by counselors employed in community addiction treatment programs and offered in conjunction with standard community addiction treatment. The investigators have completed a Stage I Safety & Practicality Study, Feasibility Study and Pilot Randomized Controlled Study (comparing ICBT versus a control condition) in community addiction treatment and for all studies found that ICBT was safe and effective in reducing PTSD symptoms, improving retention, and in reducing substance use. The present study proposes to conduct a Stage I study of ICBT among Operation Enduring Freedom (OEF) Operation Iraqi Freedom (OIF) and Operation New Dawn (OND) Veterans within the Veterans Affairs treatment setting. The investigators will modify the existing ICBT for testing in a VA setting, and use a combined individual and group modality.
There are 3 specific aims for this study, and hypotheses for each aim:
Aim 1: To test the feasibility of ICBT with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at 3- and 6-month follow-up (Stage I Phase I: Safety and practicality testing; Feasibility Study).
- This aim is to test the effect of ICBT on symptoms of PTSD and substance use disorders among returning OEF/OIF/OND Veterans seen in a VA clinic. ICBT will be tested with 16 Veterans who meet criteria for both PTSD and substance use disorder at the PTSD or SATP clinics. The investigators propose that ICBT will result in significant reductions in PTSD and substance use severity from baseline to follow-up assessment.
- Hypothesis 1: Participants receiving ICBT will have significant reductions in PTSD symptom severity as assessed by their Clinician Administered PTSD Scale (CAPS) score from baseline to a 6-month follow-up assessment.
- Hypothesis 2: Participants receiving ICBT will have significant reductions in substance use as assessed by their Addiction Severity Index (ASI) drug and alcohol severity composite scores from baseline to a 6-month follow-up assessment.
Aim 2: To revise the ICBT materials and protocol based on Stage I Phase I findings (Stage I Phase II).
-Based on experience and lessons learned in Stage I Phase I, the investigators will refine and improve the ICBT approach and study methods for teh Stage I Phase III randomized pilot trial.
Aim 3: To conduct a randomized controlled pilot trial comparing ICBT plus standard Substance Abuse Treatment Program (SATP) or PTSD care versus standard SATP or PTSD care alone, with OEF/OIF/OND Veterans diagnosed with PTSD and substance use disorders, and assess substance use and PTSD outcomes at post treatment and 3-month post treatment follow-up (Stage I Phase III: Randomized Pilot Trial).
- The efficacy of ICBT will be tested among 64 Veterans who screen positive for both disorders and are randomly assigned to either ICBT or standard treatment.
- Hypothesis 1: Participants receiving ICBT plus standard care will have greater reductions in PTSD symptoms, as assessed by their CAPS score from baseline to follow-up, than participants receiving standard care alone.
- Hypothesis 2: Participants receiving ICBT plus standard care will have greater reductions in substance use, as assessed by their ASI drug and alcohol severity composite scores from baseline to follow-up, as compared to participants receiving standard care alone.
Potential subjects will be receiving PTSD or substance use treatment services at the Providence Veterans Affairs Medical Center (PVAMC), and will be referred by clinicians in these respective clinics for participation in the study. Patients will be approached by the 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 is engaged in the process of informed consent.
If consent is granted, the subjects 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 Axis I DSM-IV substance use disorders: Clinician Administered PTSD Scale (CAPS) and the Structured Clinical Interview for DSM-IV-TR, Patient Edition (SCID-I/P) Section E.
- 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:
- 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).
- Depression: Patient Health Questionnaire-9 (PHQ-9).
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 eligible to participate. For Stage I Phase I, the patient would receive the ICBT therapy. For Stage I Phase III, the patient would be randomized to receive either the ICBT therapy plus standard treatment, or standard treatment only.
Research assessments are then also conducted at three months and six months post baseline assessment. This follow-up assessment will consist of the same measures administered at baseline, with the exception of the SCID interview.
The investigators plan to enroll approximately 16 subjects in the Stage I Phase I and to randomize approximately 64 subjects in the Stage I Phase III of the study. The subject outcome and program experiences with the protocol will be used in planning the subsequent federal grant application for a randomized controlled trial.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrated Cognitive Behavioral Therapy for Co-Occurring PTSD and Substance Use Disorders|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
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
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.
Individual or group therapy as usual within the SATP or PTSD clinics at the PVAMC
Other Name: TAU
- 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 ]
- 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 ]
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
|United States, Rhode Island|
|Providence Veterans Affairs Medical Center (PVAMC)|
|Providence, Rhode Island, United States, 02908|
|Principal Investigator:||Mark P. McGovern, Ph.D.||Dartmouth-Hitchcock Medical Center|