Contingency Outcomes in Prolonged Exposure

Not Applicable

Completed

• Conditions: Substance Use Disorder; Posttraumatic Stress Disorder
• Interventions: Behavioral: Prolonged Exposure Therapy; Behavioral: Voucher-Based Reinforcement

• Registration Number: NCT01693978
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-26
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reinforced Prolonged Exposure (RPE)	Prolonged Exposure Therapy	All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks. RPE participants will receive voucher-based reinforcement contingent on attendance to scheduled Prolonged Exposure therapy sessions.
Standard Prolonged Exposure (SPE)	Prolonged Exposure Therapy	All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.
Reinforced Prolonged Exposure (RPE)	Voucher-Based Reinforcement	All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks. RPE participants will receive voucher-based reinforcement contingent on attendance to scheduled Prolonged Exposure therapy sessions.

Primary Outcome Measures

Name	Time	Method
Prolonged Exposure session attendance	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 Outcome Measures

Name	Time	Method
Drug use	12 weeks	Groups will be compared on weekly drug test results (presence/absence of drug) and on self-reported number of days using each drug during the 12-week treatment phase.
PTSD symptoms	24 weeks	Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)

Trial Locations

Locations (1)

Addiction Treatment Services; 🇺🇸 Baltimore, Maryland, United States