- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01693978
Contingency Outcomes in Prolonged Exposure (COPE)
30. august 2016 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
126
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21224
- Addiction Treatment Services
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 100 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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 navne:
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 navne:
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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.
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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 navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Prolonged Exposure session attendance
Tidsramme: 12 weeks
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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).
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12 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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PTSD symptoms
Tidsramme: 24 weeks
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Groups will be compared on PTSD symptoms (as measured by CAPS scores) collected at each assessment timepoint (baseline, week 6, week 12, week 24)
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24 weeks
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Drug use
Tidsramme: 12 weeks
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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.
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12 weeks
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jessica Peirce, Ph.D., Johns Hopkins University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. september 2012
Primær færdiggørelse (Faktiske)
1. juni 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
21. september 2012
Først indsendt, der opfyldte QC-kriterier
24. september 2012
Først opslået (Skøn)
26. september 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. august 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. august 2016
Sidst verificeret
1. august 2016
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1R34DA032689-01A1 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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