Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
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|ClinicalTrials.gov Identifier: NCT02461732|
Recruitment Status : Completed
First Posted : June 3, 2015
Last Update Posted : May 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder Substance Dependence||Behavioral: Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS) Behavioral: Cognitive-Behavioral Therapy for Substance Dependence||Not Applicable|
The proposed study is a randomized controlled clinical trial, comparing the efficacy of two cognitive-behavioral therapy (CBT) interventions: standard CBT for substance dependence and a novel integrated CBT program for PTSD and substance dependence. The study will run for approximately 3 years. A total of 100 participants will be enrolled at a rate of 4 participants per month over 25 months to ensure that 80 participants complete the protocol (presuming 20% attrition). Each participant will attend 12 treatment sessions, meeting twice per week for 6 weeks. Treatment sessions will last 1-hour each.
Primary study outcomes will include frequency and quantity of substance use and PTSD symptom severity. Substance use-related outcomes will include: rates of substance abstinence, as measured by (1) urine toxicology testing, (2) alcohol breath level analyses, and (3) participants' self-report of substance use. PTSD symptom outcomes will include symptom severity ratings as measured by clinical interview (i.e., Clinician-Administered PTSD Scale-5; CAPS-5) and self-report (Posttraumatic Checklist; PCL-5).
Secondary study outcomes will include examination of mediational effects. Specifically, changes in distress tolerance, as indexed via self-report (Distress Tolerance Scale) and computer/behavioral tasks (i.e., Mirror-Tracing Task, Paced Auditory Serial Addition Task-Computerized Version, Breath-Holding Task), are expected during the course of the treatment. Changes in cue reactivity are also expected over the course of treatment, as indexed by decreased psychophysiological reactivity (heart rate, respiration rate) during script-driven imagery tasks (listening to trauma/drug related scripts vs. netural). A total of four sessions (baseline/screening and sessions 4, 8, 12) will be preceded by the laboratory sessions.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Active Comparator: CBT for Substance Dependence
Standard CBT for substance use disorders
Behavioral: Cognitive-Behavioral Therapy for Substance Dependence
Topics covered include:
drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities
Experimental: Integrated CBT for PTSD and Substance Dependence
Integrated CBT for PTSD and substance use disorders, combining elements of cognitive processing therapy for PTSD with coping skills and relapse prevention for substance use disorders
Behavioral: Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS)
Topics covered include:
drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities; education on PTSD and trauma/PTSD/substance use associations; discussion and written statement of impact of trauma on beliefs about self, others, world; written account of trauma memory and in-session review and discussion; cognitive exercises and cognitive restructuring regarding trauma-related thoughts; review of any between-session trauma-relevant substance use and cravings
- PTSD Symptoms [ Time Frame: for the duration of the study / through the conclusion of treatment, up to 8 weeks ]PCL-5 self-report measure: severity of symptoms
- Substance Use [ Time Frame: for the duration of the study / through the conclusion of treatment, up to 8 weeks ](1) rates of substance abstinence, as measured via urine toxicology testing, alcohol breath level analyses, and participants' self-reports of substance use; (2) longest sustained abstinence, defined as the maximum number of self-reported days of abstinence for each participant.
- PTSD Diagnosis [ Time Frame: for the duration of the study / through the conclusion of treatment, up to 8 weeks ]CAPS interview measure: severity of symptoms
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): NCT02461732
|United States, Texas|
|University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction|
|Houston, Texas, United States, 77054|