Contingency Outcomes in Prolonged Exposure (COPE)
2016年8月30日 更新者: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.
調査の概要
研究の種類
介入
入学 (実際)
126
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
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Maryland
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Baltimore、Maryland、アメリカ、21224
- Addiction Treatment Services
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年~100年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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).
他の名前:
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).
他の名前:
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アクティブコンパレータ: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).
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Prolonged Exposure session attendance
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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PTSD symptoms
時間枠: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
時間枠: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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者:Jessica Peirce, Ph.D.、Johns Hopkins University
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2012年9月1日
一次修了 (実際)
2015年6月1日
研究の完了 (実際)
2015年9月1日
試験登録日
最初に提出
2012年9月21日
QC基準を満たした最初の提出物
2012年9月24日
最初の投稿 (見積もり)
2012年9月26日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年8月31日
QC基準を満たした最後の更新が送信されました
2016年8月30日
最終確認日
2016年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 1R34DA032689-01A1 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。