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Mindfulness-Based Relapse Prevention for Methadone Maintenance

2019年3月18日 更新者:Sarah Bowen、Pacific University

Mindfulness-Based Relapse Prevention for Methadone Maintenance: A Feasibility Trial

The current study was designed to inform protocol adaptation, and to evaluate the feasibility, acceptability, and preliminary efficacy of a mindfulness-based intervention for methadone maintenance clients. Adults (N=15) were recruited from a methadone clinic to participate in a 6-week mindfulness course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within this client population.

調査の概要

詳細な説明

As rates of opiate misuse rise in the United States, there areso do significant associated health, and financial consequences to afflicted individuals, their families, and society at large. Methadone Maintenance Therapy (MMT) is one evidence-based approach to treating individuals with opiate addiction, yet supplemental psychosocial treatment to support this approach is lacking. Mindfulness-Based Relapse Prevention (MBRP) has shown to be efficacious in various substance use populations, but has yet to be assessed with MMT clients. The current study was designed to inform protocol adaptation for to MMT clients, and to evaluate the feasibility, acceptability, and preliminary efficacy of a MBRP for this population. The sample consisted of adults (N=15) recruited from a methadone clinic to participate in a 6-week MBRP course. Indices of feasibility, including recruitment, retention, data from focus groups and course satisfaction surveys, supported feasibility of the intervention. Outcome measures were self-report, and included self-compassion, depression, craving, PTSD symptoms, and experiential avoidance, and were assessed at baseline, postcourse, and 1-month follow-up. Data were analyzed using qualitative and quantitative approaches. Mean scores on all primary outcomes changed in the expected direction at both postcourse and 1-month follow-up assessment, although only depression and experiential avoidance reached significance. Results from this initial pilot support feasibility and acceptability, and provide preliminary data on outcomes for future trials of mindfulness-based approaches within the MMT community.

研究の種類

介入

入学 (実際)

14

段階

  • 適用できない

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~70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:

  • Clearance from clinic staff
  • Currently enrolled in a methadone maintenance program
  • Agree to complete assessment questionnaires and attend treatment sessions
  • Fluent in English

Exclusion Criteria:

  • Indication of active psychosis
  • Participation in past mindfulness-based relapse prevention group

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:なし
  • 介入モデル:単一グループの割り当て
  • 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
実験的:Mindfulness
Assigned to a 6-week mindfulness-based relapse prevention course
Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches

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
Acceptability - Satisfaction with the Course
時間枠:post course (6 weeks)
Satisfaction with the course will be assessed using the Overall Course Satisfaction Survey, items #1-4 (Bowen, Chawla, & Marlatt, 2010). This is a self-report questionnaire, the first 4 items of which are open-ended questions assessing satisfaction with the course, barriers to learning, and perceived helpfulness.
post course (6 weeks)
Acceptability - Enactment of Learned Skills
時間枠:post course (6 weeks)
Enactment will be assessed using the Overall Course Satisfaction Survey, items #5-7 (Bowen, Chawla, & Marlatt, 2010). This is a self-report questionnaire, the last 3 questions of which are 10-point Likert-type items, and assess importance of skills and likelihood of implementing them into daily life after the course ends. Higher scores indicate higher perceived importance and likelihood.
post course (6 weeks)

二次結果の測定

結果測定
メジャーの説明
時間枠
Depression
時間枠:1 month
Depression symptoms will be assessed using the Beck Depression Inventory-II, a 21-item self report measure. Items are summed for a total score ranging from 0-63. A score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
1 month
Anxiety
時間枠:1 month
Anxiety symptoms will be assessed using the Beck Anxiety Inventory, a 21-item self report measure. Items are summed for a total score that can range between 0 and 63 points. A total score of 0 - 7 is interpreted as a Minimal anxiety, 8 - 15 as Mild, 16 - 25 as Moderate, and 26 - 63 as Severe.
1 month
Craving
時間枠:1 month
Craving for substances will be assessed using the Penn Alcohol Craving Scale, a five-item Likert-scaled measure assessing frequency, intensity, duration, and overall levels of craving, adapted to include both alcohol and drugs. Each question is scaled from 0 to 6. Sum scores range from 0-30, with greater scores indicating higher craving.
1 month
Trauma symptoms
時間枠:1 month
PTSD symptoms will be assessed using the Post-Traumatic Stress Disorder Checklist-Civilian (PCL-C), which measures presence and severity of trauma symptoms using 16-item Likert-scaled questionnaire.
1 month
Experiential avoidance
時間枠:1 month
The Acceptance and Action Questionnaire (AAQ) is a widely used measure of experiential avoidance and psychological inflexibility consisting of nine Likert-scaled items, answer options ranging from 1 (never true) to 7 (always true). High scores reflect greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.
1 month

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

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 (実際)

2015年2月15日

一次修了 (実際)

2015年6月27日

研究の完了 (実際)

2015年6月27日

試験登録日

最初に提出

2017年4月3日

QC基準を満たした最初の提出物

2019年3月18日

最初の投稿 (実際)

2019年3月20日

学習記録の更新

投稿された最後の更新 (実際)

2019年3月20日

QC基準を満たした最後の更新が送信されました

2019年3月18日

最終確認日

2019年3月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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