Contingency Outcomes in Prolonged Exposure

NCT01693978 | Completed

• 1 other identifier: 1R34DA032689-01A1
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Substance Use Disorder

Keywords

PTSD; Prolonged Exposure; Comorbidity; Treatment; Methadone Maintenance; Substance Use Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• PTSD symptoms

  24 weeks

• Drug use

  12 weeks

Study Arms (2)

Reinforced Prolonged Exposure (RPE)

EXPERIMENTAL

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; Behavioral: Voucher-Based Reinforcement

Standard Prolonged Exposure (SPE)

ACTIVE COMPARATOR

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

Interventions

Prolonged Exposure Therapy BEHAVIORAL

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).

Also known as: PE Therapy

Reinforced Prolonged Exposure (RPE); Standard Prolonged Exposure (SPE)

Voucher-Based Reinforcement BEHAVIORAL

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).

Also known as: Vouchers

Reinforced Prolonged Exposure (RPE)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Addiction Treatment Services

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Jessica Peirce, Ph.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 26, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2015
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

US (1)