Skip to main content
Clinical Trials/NCT01693978
NCT01693978
Completed
Not Applicable

Incentivizing Adherence to Prolonged Exposure With Substance Users

Johns Hopkins University1 site in 1 country126 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
Johns Hopkins University
Enrollment
126
Locations
1
Primary Endpoint
Prolonged Exposure session attendance
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

The aim of this research is to assess whether Contingency Management is effective in improving treatment adherence in substance use disordered (SUD) patients with comorbid PTSD. Although Prolonged Exposure therapy (PE) is the gold standard treatment for PTSD, the few studies of this treatment in substance users have shown poor adherence. Contingency Management is a well-established approach that could be used to enhance adherence to PE. From a consented sample of 125 opioid-dependent and methadone-treated patients at Addiction Treatment Services, an intent-to-treat sample of 62 patients with co-occurring current PTSD will be offered PE. Half of the 62 participants will be randomly assigned to a Prolonged Exposure with Contingency Management (PE+CM) condition that provides monetary-based incentives for attending the PE therapy sessions. The comparison condition will be assigned to a Prolonged Exposure (PE) condition without the attendance incentives intervention. The PE sessions will be scheduled once per week for 12 weeks, with a 12-week follow-up. Groups will be compared primarily on adherence to the PE schedule, improvement in PTSD symptoms, and rates of drug use (urine specimens, self-reported use). The study's three primary aims are to 1) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to increase adherence in SUD patients in a methadone treatment program; 2) Evaluate the efficacy of adding voucher-based attendance incentives to PE for PTSD to reduce PTSD symptoms in SUD patients; and 3) Evaluate the effect of PE for PTSD on rates of drug use in SUD patients.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jessica Peirce

Assistant Professor

Johns Hopkins University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • pregnancy
  • acute medical problem that requires immediate and intense medical management (e.g., AIDS defining illness; active tuberculosis)
  • presence of a formal thought disorder, delusions, hallucinations, or imminent risk of harm to self or others

Outcomes

Primary Outcomes

Prolonged Exposure session attendance

Time Frame: 12 weeks

PE session attendance will be measured as the percent of participants completing a full course of PE and as a repeating dichotomous variable (weekly assessments of attended vs. unattended sessions).

Secondary Outcomes

  • Drug use(12 weeks)
  • PTSD symptoms(24 weeks)

Study Sites (1)

Loading locations...

Similar Trials