Online Mindfulness-based Stress Reduction Intervention for People With Chronic Pain Waiting for Health Services
2022年9月20日 更新者：Diana Zidarov、Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal
Online Mindfulness-based Stress Reduction Intervention for Chronic Pain in Individuals Waiting for Health Care Services: a Study Protocol for a Pilot Randomized Controlled Trial (RCT)
The goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services
調査の概要
研究の種類
介入
入学 (実際)
60
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
-
-
Quebec
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Montreal、Quebec、カナダ、H1V2C8
- Association québécoise de la douleur chronique
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Montreal、Quebec、カナダ、H4B 1T3
- Centre de réadaptation Layton-Lethbridge-Mackay
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Montreal、Quebec、カナダ、H4G 2A3
- Hôpital de Verdun
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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～85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:
- Men and women aged 18-85
- Self-reported diagnosis of chronic non-cancer pain
- Chronic non-cancer pain duration of 3 months or more
- Chronic non-cancer pain experienced during 4 days or more per week
- Average pain intensity of 4 or more out of 10 in the last seven days
- French or English fluency
- Access to Wi-Fi
- Be able to attend a weekly two-hour MBSR virtual session for eight consecutive weeks
Exclusion Criteria:
- Cancer-related chronic pain
- Currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers.
- Current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or MBSR program
- Having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder
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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
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：Mindfulness-based stress reduction intervention
Online 8-week group program, once per week
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An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR.
Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body.
Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended.
To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.
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介入なし：Waiting list
Controls will not receive any intervention during this time.
They are on chronic pain clinics waiting list
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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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Participants retention rate
時間枠：2 months
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The percentage of participants who have completed the 8 online MBSR sessions
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2 months
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Participants participation rate
時間枠：12 months
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The percentage of participants on waiting lists who agreed to participate in the intervention
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12 months
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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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Patient-Reported Outcomes Measurement Information System Global-10
時間枠：Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in domains of health and functioning as measured by the PROMIS Global-10, score range is 7-35 with increases in scores meaning better outcome
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Patient-Reported Outcomes Measurement Information System 29
時間枠：Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in 8 health-related quality of life domains as measured by the PROMIS 29.
PROMIS-29 is a generic patient reported outcome measure, which includes four items from each of the seven PROMIS domains (physical function, depression, anxiety, fatigue, sleep disturbance, and ability to participate in social roles and activities, pain interference) and a single item on pain intensity.
Each item has five response options (values 1 to 5), except for the pain intensity item which has eleven response options (values 0 to 10).
A total raw score is computed for each domain as the sum of the response to each question within the domain, leading to seven domain scores, each from 4 to 20.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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French-Canadian Chronic Pain Self-Efficacy Scale
時間枠：Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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The French-Canadian Chronic Pain Self-Efficacy Scale (Lacasse et al., 2015) is a 6-item scale that measures an individual's confidence in his/her ability to manage chronic pain in general and pain-related symptoms.
Items are rated on a 10-point Likert scale ranging from 1 = not at all confident to 10 = entirely confident.
Score range is 6-60 with higher scores reflecting greater chronic pain self-efficacy.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Chronic Pain Acceptance Questionnaire
時間枠：Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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The Chronic Pain Acceptance Questionnaire (CPAQ-8; Fish et al., 2010 ) is an 8-item scale comprised of two subscales: activity engagement and pain willingness.
Items are scored on a 7-point Likert scale ranging from 0 = never true to 6 = always true.
Score range is 0-48 with increases in scores meaning better outcome.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Global Rating of Change Scale
時間枠：3-month follow-up (week 21)
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The Global Change Rating Scale (11-point visual analogue scale raging from minus 5 to plus 5) will be used to assess the participants' perception of improvement (or decline) in relation to their self-efficacy in manging pain at the end of the MBSR intervention.
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3-month follow-up (week 21)
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Pain Catastrophizing Scale
時間枠：Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in pain catastrophizing as measured by the Pain Catastrophizing Scale (French Canadian version).
PCS is a 13-item measure using a 5-point Likert scale (0=not at all, 4=all the time) with score range between 0-52 with decreases in scores meaning better outcome.
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Pain Disability Index
時間枠：Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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Change in pain disability as measured by the The French-Canadian Pain Disability Index (score range is 0-70 with decreases in scores meaning better outcome)
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Change from week start of MBSR intervention (week 0) to end of intervention (week 8), 3-month follow-up (week 21)
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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。
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)
2021年6月16日
一次修了 (実際)
2021年12月20日
研究の完了 (実際)
2022年1月24日
試験登録日
最初に提出
2021年4月8日
QC基準を満たした最初の提出物
2021年4月8日
最初の投稿 (実際)
2021年4月13日
学習記録の更新
投稿された最後の更新 (実際)
2022年9月22日
QC基準を満たした最後の更新が送信されました
2022年9月20日
最終確認日
2022年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- CRIR-1499-1120/multi
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?
いいえ
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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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