Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence

NCT ID: NCT02461732

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2016-11-30

Brief Summary

The purpose of the study is to determine whether a novel integrated cognitive-behavioral treatment for posttraumatic stress disorder (PTSD) and substance dependence (i.e., Treatment for Integrated Posttraumatic Stress and Substance use; TIPSS) is more effective than cognitive-behavioral treatment for substance dependence alone with regard to PTSD symptoms and substance use quantity and frequency.

Detailed Description

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.

Conditions

Posttraumatic Stress Disorder; Substance Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT for Substance Dependence

Standard CBT for substance use disorders

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy for Substance Dependence

Intervention Type: BEHAVIORAL

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

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

Group Type: EXPERIMENTAL

Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS)

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-65
• English language proficiency
• Current (past month) substance dependence, noting exclusions as delineated below
• History of trauma exposure, as per DSM-5 Criterion A1 definition
• Current (past month) PTSD symptoms: score of at least 25 on PCL-5 and/or at least 4 symptoms of moderate severity (scored 2 or higher) endorsed on CAPS-5
• Seeking treatment for trauma-related symptoms and substance dependence

Exclusion Criteria

• Exclusive [only] nicotine dependence
• Alcohol dependence requiring detoxification
• Opiate dependence requiring detoxification
• Current or past bipolar I disorder
• Current or past major psychotic disorder
• Active (past 6 months) psychotic spectrum symptoms
• Major unstable medical conditions
• Current (past month) suicidal ideation with intent and/or plan
• Current (past month) homicidal ideation with intent and/or plan
• Inability to provide verbal/written consent

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Anka A Vujanovic

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Texas Health Science Center at Houston - Center for Neurobehavioral Research on Addiction

Houston, Texas, United States

Countries

United States

Other Identifiers

HSC-MS-14-0486

Identifier Type: -

Identifier Source: org_study_id