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Contingency Outcomes in Prolonged Exposure (COPE)

Primary Purpose

Posttraumatic Stress Disorder, Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prolonged Exposure Therapy
Voucher-Based Reinforcement
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Prolonged Exposure, Comorbidity, Treatment, Methadone Maintenance, Substance Use Disorder

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addiction Treatment Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Reinforced Prolonged Exposure (RPE)

Standard Prolonged Exposure (SPE)

Arm Description

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.

All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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)
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.

Full Information

First Posted
September 21, 2012
Last Updated
August 30, 2016
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT01693978
Brief Title
Contingency Outcomes in Prolonged Exposure
Acronym
COPE
Official Title
Incentivizing Adherence to Prolonged Exposure With Substance Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Substance Use Disorder
Keywords
PTSD, Prolonged Exposure, Comorbidity, Treatment, Methadone Maintenance, Substance Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reinforced Prolonged Exposure (RPE)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Prolonged Exposure (SPE)
Arm Type
Active Comparator
Arm Description
All participants will be scheduled to attend a weekly Prolonged Exposure therapy session for 12 consecutive weeks, and followed for 12 additional weeks.
Intervention Type
Behavioral
Intervention Name(s)
Prolonged Exposure Therapy
Other Intervention Name(s)
PE Therapy
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Voucher-Based Reinforcement
Other Intervention Name(s)
Vouchers
Intervention Description
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).
Primary Outcome Measure Information:
Title
Prolonged Exposure session attendance
Description
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).
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
PTSD symptoms
Description
Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)
Time Frame
24 weeks
Title
Drug use
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jessica Peirce, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Treatment Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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Contingency Outcomes in Prolonged Exposure

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