Trial of a Novel Cognitive-Behavioral Treatment for Posttraumatic Stress and Substance Dependence
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, Psychiatric, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/11/2017 |
| Start Date: | August 2014 |
| End Date: | November 2016 |
Randomized Controlled 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.
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.
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.
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.
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
We found this trial at
1
site
Houston, Texas 77054
Phone: 713-486-2823
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