慢性腰痛に対するマインドフルネスベースのダンス/ムーブメントセラピー
The purpose of this study is to evaluate the feasibility, acceptability and credibility of a mindfulness-based dance/movement therapy (M-DMT) protocol that is delivered online; to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of M-DMT; and to demonstrate proof of principle by gathering information about the process of change between M-DMT and a control condition.
This is the first study to address the potential of M-DMT as a creative, non-opioid intervention for chronic back pain. Therefore, the findings of this study will provide important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research, namely a fully powered RCT to evaluate efficacy and treatment mechanisms of action. Data obtained as part of this study will be instrumental for informing the systematic evaluation of M-DMT for chronic back pain care.
調査の概要
状態
条件
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19102
- Drexel Universitsy
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria
- age > 18 years
- current non-specific cLBP that has persisted at least 3 months, and has resulted in pain on at least half the day in the past 6 months
- proficient in English
- average pain severity and interference ratings >3/10 on a 0-10 numeric rating scale
- if taking pain medication(s), dosage must be stabilized for a minimum of 3 months
- patients agree not to seek additional therapies for the duration of this study beyond those already included in their current treatment regimen or new treatments prescribed by their physician
- naïve to DMT.
- those who have adequate computer literacy (e.g., know how to use a computer to perform basic tasks such as open/send emails, use internet, fill-out online surveys) and access to the virtual delivery format (i.e., internet service and a personal computer device such as laptop, desktop, tablet PC).
Exclusion Criteria:
- pregnancy
- severe and/or progressive medical, neurological, substance dependence within the last 6 months or severe mental illness (i.e., psychosis, mania) that would prevent active participation
- cognitive impairment that prohibits informed consent
- back surgery in the last 6 months
- low back pain attributable to a recognizable, known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome
- wheelchair-bound or unable to move without assistance
- involvement in impending litigation or judgment for disability or worker's compensation.
研究計画
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：独身
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 dance/movement therapy
Participants assigned to the M-DMT group condition will receive care as usual plus 12 weekly 90-minute group M-DMT sessions delivered online by a board-certified dance/movement therapist. The therapist is instructed to follow the M-DMT manualized protocol. |
M-DMT includes benefits of physical activity, group psychotherapy, mindfulness training, and an art-based intervention in a unified practice. Each online session focuses on different psycho-educational topics about chronic low back pain management and links these topics with specific M-DMT activities that incorporate mindfulness-based principles and techniques.
他の名前：
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アクティブコンパレータ：Chronic pain social support group
Participants assigned to the control condition will participate in a 12-session (90-minute session/week) online social support group. |
The therapist will facilitate online open group discussions about participants' experiences with or reactions to the topic of discussion and will promote empathy among group members. The therapist will use client-centered, reflective listening techniques but will not prescribe any specific recommendations for change. Each week, SSG participants will receive emails with brief information about the topic discussed during the group session. |
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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Feasibility of Recruitment: Number of participants eligible
時間枠：Baseline
|
Number of participants eligible for randomization to the study intervention |
Baseline
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Recruitment Rate
時間枠：Baseline
|
Proportion of participants randomized relative to total trial referrals |
Baseline
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Recruitment time
時間枠：Baseline
|
Number of participate enrolled per month |
Baseline
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Feasibility of recruiting male participants: Proportion of male participant enrolled
時間枠：Baseline
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Proportion of male participant enrolled to the study |
Baseline
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Treatment Completion Rate
時間枠：12 weeks following receipt of treatment
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We expect 80% of participants to complete at least 9/12 M-DMT sessions |
12 weeks following receipt of treatment
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Retention Rate
時間枠：24 weeks
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Proportion of participants who complete follow-up questionnaires |
24 weeks
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Reason for withdrawal
時間枠：12 weeks following receipt of treatment
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Assessed by an open-ended question, "What was the reason for discontinuing your participation?" administered by a study staff during a phone interview |
12 weeks following receipt of treatment
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M-DMT intervention credibility and expectancy
時間枠：1 week
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Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility) |
1 week
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Treatment Fidelity
時間枠：1-12 weeks
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Treatment fidelity assessment form developed by the researcher (range: varies between sessions depending on the number of items included in the particular session; A total score of 80% and higher reflects adequate treatment fidelity) |
1-12 weeks
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Treatment satisfaction and acceptability: Likert-scale survey
時間枠：12 weeks post-randomization
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via Likert-scale surveys; on scale of 1 to 5, 1 being not satisfied; 5 being very satisfied (i.e higher number, better outcome). |
12 weeks post-randomization
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M-DMT intervention acceptability
時間枠：12 weeks
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Exit interview based on an interview protocol developed by the researcher |
12 weeks
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Adverse Event
時間枠：1 -12 weeks
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Number of adverse events |
1 -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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Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a
時間枠：Change from Baseline pain intensity at 6, 12, and 24-week time points
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PROMIS® Pain Intensity-Short Form (SF)3a (A 5-point (from 1= Had no pain to 5= Very Severe) rating scale is used in each of the 3 items; higher results mean higher intensity of pain. |
Change from Baseline pain intensity at 6, 12, and 24-week time points
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Pain interference: PROMIS® Pain Interference -8a
時間枠：Change from Baseline pain interference at 6, 12, and 24-week time points
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PROMIS® Pain Interference -8a (A 5-point (from 1= Not at all to 5= Very much) rating scale is used on each of the 8 items; higher scores reflect greater pain interference |
Change from Baseline pain interference at 6, 12, and 24-week time points
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Chronic pain acceptance: Chronic Pain Acceptance Questionnaire
時間枠：Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
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Chronic Pain Acceptance Questionnaire (A seven-point (from 0= Never to 6 = Always) rating scale is used in each of the 20 items; higher results mean high pain acceptance) |
Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
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Mindfulness
時間枠：Change from Baseline mindfulness at 6, 12, and 24-week time points
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Cognitive and Affective Mindfulness Scale (A 4-point (Rarely/not at all to almost always) rating scale is used in each of the 12 items; higher values reflect higher mindful qualities |
Change from Baseline mindfulness at 6, 12, and 24-week time points
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Physical activity (Accelerometry data)
時間枠：Change from Baseline physical activity at 12, and 24-week time points
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An accelerometer, ActiGraph GT9X will be used to measure the change in participants physical activity between baseline and 2 endpoints (12 and 24 weeks) |
Change from Baseline physical activity at 12, and 24-week time points
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Physical activity (Self-report data)
時間枠：Change from Baseline physical activity at 6, 12, and 24-week time points
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Self-report assessment of physical activity will be done through UCLA Activity Scale (One item out of 10 will be checked to best describe current activity level) |
Change from Baseline physical activity at 6, 12, and 24-week time points
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Physical Function
時間枠：Change from Baseline physical function at 6, 12, and 24-week time points
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PROMIS® Physical function-20a (A 5-point (5= without any difficulty to 1= Unable to do) rating scale is used in each of the 20 items; higher values reflect higher abilities to physically function |
Change from Baseline physical function at 6, 12, and 24-week time points
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Depression
時間枠：Change from Baseline depression at 6, 12, and 24-week time points
|
PROMIS® Emotional Distress-Depression-SF 4a (A 5-point (1= Never to 5= Always) rating scale is used in each of the 4 items; higher values reflect higher levels of depression |
Change from Baseline depression at 6, 12, and 24-week time points
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Sleep Disturbance
時間枠：Change from Baseline sleep disturbance at 6, 12, and 24-week time points
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PROMIS® Sleep Disturbance-4a (A 5-point (5= Very poor to 1= Very good) rating scale is used in each of the 4 items; higher values reflect higher levels of sleep disturbances |
Change from Baseline sleep disturbance at 6, 12, and 24-week time points
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Pain Catastrophizing: Pain Catastrophizing Scale
時間枠：Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
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Pain Catastrophizing Scale - short form(SF)-4a (A 4-point (0= Not at all to 4= All the time) rating scale is used in each of the 4 items; higher scores reflect greater pain catastrophizing |
Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
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Kinesiophobia
時間枠：Change from Baseline kinesiophobia at 6, 12, and 24-week time points
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Tampa Scale of Kinesiophobia (A 4-point (1= Strongly disagree to 4= Strongly agree) rating scale is used in each of the 11 items; higher values reflect higher levels of kinesiophobia |
Change from Baseline kinesiophobia at 6, 12, and 24-week time points
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Patient Perception of Change
時間枠：12 weeks
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Score on single item Patient Global Impression of Change Rating (range: 1 (No change) to 7 (a great deal better)) |
12 weeks
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Minjung Shim, PhD、Drexel University
- 主任研究者：Adam Gonzalez, PhD、Stony Brook University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 1810006694
- 7R34AT009555-02 (米国 NIH グラント/契約)
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?
医薬品およびデバイス情報、研究文書
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