- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03882125
Mindfulness-Based Relapse Prevention for Methadone Maintenance
2019년 3월 18일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
14
단계
- 해당 없음
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Mindfulness
Assigned to a 6-week mindfulness-based relapse prevention course
|
Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Acceptability - Satisfaction with the Course
기간: 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
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Depression
기간: 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
기간: 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
기간: 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.
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1 month
|
|
Trauma symptoms
기간: 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
기간: 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.
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1 month
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2015년 2월 15일
기본 완료 (실제)
2015년 6월 27일
연구 완료 (실제)
2015년 6월 27일
연구 등록 날짜
최초 제출
2017년 4월 3일
QC 기준을 충족하는 최초 제출
2019년 3월 18일
처음 게시됨 (실제)
2019년 3월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2019년 3월 20일
QC 기준을 충족하는 마지막 업데이트 제출
2019년 3월 18일
마지막으로 확인됨
2019년 3월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .