Contingency Outcomes in Prolonged Exposure

Posttraumatic Stress Disorder Clinical Trial

— COPE  

Official title:

Incentivizing Adherence to Prolonged Exposure With Substance Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693978
• Other study ID #: 1R34DA032689-01A1
• Status: Completed
• Phase: N/A
• First received: September 21, 2012
• Last updated: August 30, 2016
• Start date: September 2012
• Est. completion date: September 2015

Study information

• Verified date: August 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria for Phase I (evaluation):

• positive screen for PTSD, as determined by score on the MPSS-R

• methadone maintenance for at least 4 weeks (to help ensure initial stabilization on methadone)

• at least 18 years of age

Inclusion criteria for Phase 2 (treatment):

• confirmation of current PTSD based on the Clinician-Administered PTSD Scale

• no psychiatric contraindications to PE (e.g., current suicidal/homicidal intent)

• clear memory for the traumatic event (e.g., flashbacks or re-experiencing the event)

• interest in receiving PE

• agree to sign release of information for any current psychiatric treatment providers outside of ATS

• agree to delay taking daily methadone dose on exposure therapy days until after session

• no history of prior exposure-based therapy for PTSD

• agree to audiotaping of therapy sessions

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Use Disorder
• Substance-Related Disorders

Intervention

Behavioral:
• Prolonged Exposure Therapy
Prolonged Exposure Therapy is considered the "gold standard" treatment for PTSD in psychiatry. It uses a cognitive-behavioral approach that repeatedly and systematically exposes patients to memories of their traumatic events to reduce fear and arousal. The PE therapy offered in this study will be based on procedures used by Foa and colleagues, described in their book-length treatment manual (Foa, Hembree, & Rothbaum, 2007).
• Voucher-Based Reinforcement
Those in the PE+CM condition will also be able to earn voucher-based incentives for each therapy session that they attend as scheduled, with a maximum of $480 for full adherence to all sessions. Specifically, participants will earn $30 for attending Session 1, $40 for attending Session 2, $50 for attending Session 3, and $60 for attending Sessions 4 through 9. There will be no payment for Sessions 10 through 12. Because it is very important that participants attend sessions on schedule, voucher values will be reset starting from $30 if participants miss a scheduled session. Vouchers can be exchanged for goods and services in the community (e.g., gift cards to local retailers).

Locations

Country	Name	City	State
United States	Addiction Treatment Services	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged Exposure session attendance	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).	12 weeks	No
Secondary	PTSD symptoms	Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)	24 weeks	No
Secondary	Drug use	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.	12 weeks	No