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Contingency Outcomes in Prolonged Exposure (COPE)
30 augustus 2016 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
126
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Maryland
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Baltimore, Maryland, Verenigde Staten, 21224
- Addiction Treatment Services
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 100 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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).
Andere namen:
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).
Andere namen:
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Actieve vergelijker: 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).
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Prolonged Exposure session attendance
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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PTSD symptoms
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Jessica Peirce, Ph.D., Johns Hopkins University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 september 2012
Primaire voltooiing (Werkelijk)
1 juni 2015
Studie voltooiing (Werkelijk)
1 september 2015
Studieregistratiedata
Eerst ingediend
21 september 2012
Eerst ingediend dat voldeed aan de QC-criteria
24 september 2012
Eerst geplaatst (Schatting)
26 september 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
31 augustus 2016
Laatste update ingediend die voldeed aan QC-criteria
30 augustus 2016
Laatst geverifieerd
1 augustus 2016
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1R34DA032689-01A1 (Subsidie/contract van de Amerikaanse NIH)
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