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Completed

NCT Number: NCT02461732

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

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.

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Key information

Conditions

Posttraumatic Stress Disorder Chemically-Induced Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Substance Dependence Substance-Related Disorders Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS)

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

Cognitive-Behavioral Therapy for Substance Dependence

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 3, 2015
Registry last updated
May 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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