CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Prolonged Exposure Therapy +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01186315
NCT01186315N/ACompleted

Developing a Computer-Based Intervention to Enhance Behavioral Treatments for PTSD and Addiction

Duke University·interventional·Posted Aug 23, 2010·Updated Aug 21, 2014

In Brief

A clinical study evaluating Prolonged Exposure Therapy and Prolonged Exposure therapy + VR/ER for Substance Use Disorders and Posttraumatic Stress Disorder. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Eligible veterans, National Guardsmen \& Reservists with post-traumatic stress disorder (PTSD) and problems with addiction will be randomly assigned to one of two treatment conditions. All participants will undergo exposure therapy, a gold standard behavioral treatment for PTSD for 10 weeks. In addition to exposure therapy, some participants will be randomly assigned to receive (1) virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use, and (2) cellular phone-based reminders of learning (extinction reminders, or, ERs) to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use. The main hypothesis is that those participants who receive exposure therapy + VR/ERs will demonstrate less substance use and lower PTSD symptoms during treatment, at post-treatment, and at follow-up than those participants who only receive exposure therapy. At study completion, a total of 123 subjects signed consent.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2010
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2013
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 15.9 years ago

Interventions

Prolonged Exposure Therapybehavioral

These treatments include repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories.

Prolonged Exposure therapy + VR/ERbehavioral

The therapy includes repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories and adding in virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use \& CER used outside treatment sessions in response to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use