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Contingency Outcomes in Prolonged Exposure (COPE)

30. august 2016 oppdatert av: Jessica Peirce, Johns Hopkins University

Incentivizing Adherence to Prolonged Exposure With Substance Users

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

126

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • Baltimore, Maryland, Forente stater, 21224
        • Addiction Treatment Services

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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).
Andre navn:
  • PE Therapy
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).
Andre navn:
  • Vouchers
Aktiv komparator: 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.
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).
Andre navn:
  • PE Therapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prolonged Exposure session attendance
Tidsramme: 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).
12 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
PTSD symptoms
Tidsramme: 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)
24 weeks
Drug use
Tidsramme: 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.
12 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Jessica Peirce, Ph.D., Johns Hopkins University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2012

Primær fullføring (Faktiske)

1. juni 2015

Studiet fullført (Faktiske)

1. september 2015

Datoer for studieregistrering

Først innsendt

21. september 2012

Først innsendt som oppfylte QC-kriteriene

24. september 2012

Først lagt ut (Anslag)

26. september 2012

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

31. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

30. august 2016

Sist bekreftet

1. august 2016

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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