Contingency Outcomes in Prolonged Exposure (COPE)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Jessica Peirce, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01693978
First received: September 21, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Posttraumatic Stress Disorder
Substance Use Disorder
Behavioral: Prolonged Exposure Therapy
Behavioral: Voucher-Based Reinforcement

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Incentivizing Adherence to Prolonged Exposure With Substance Users

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Prolonged Exposure session attendance [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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:
  • PTSD symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)

  • Drug use [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 125
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reinforced Prolonged Exposure (RPE)
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.
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).
Other Name: PE Therapy
Behavioral: 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).
Other Name: Vouchers
Active Comparator: Standard Prolonged Exposure (SPE)
All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.
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).
Other Name: PE Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693978

Locations
United States, Maryland
Addiction Treatment Services
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Jessica Peirce, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Jessica Peirce, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01693978     History of Changes
Other Study ID Numbers: 1R34DA032689-01A1
Study First Received: September 21, 2012
Last Updated: September 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
PTSD
Prolonged Exposure
Comorbidity
Treatment
Methadone Maintenance
Substance Use Disorder

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Substance-Related Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014