Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Feasibility of recruiting male participants: Proportion of male participant enrolled
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Mindfulness-based dance/movement therapy (M-DMT) (Behavioral)
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.
干预措施: Chronic pain social support group (Behavioral)
结局指标
主要结局
Feasibility of recruiting male participants: Proportion of male participant enrolled
时间窗: Baseline
Proportion of male participant enrolled to the study
Treatment Completion Rate
时间窗: 12 weeks following receipt of treatment
We expect 80% of participants to complete at least 9/12 M-DMT sessions
Retention Rate
时间窗: 24 weeks
Proportion of participants who complete follow-up questionnaires
Recruitment time
时间窗: Baseline
Number of participate enrolled per month
Feasibility of Recruitment: Number of participants eligible
时间窗: Baseline
Number of participants eligible for randomization to the study intervention
Recruitment Rate
时间窗: Baseline
Proportion of participants randomized relative to total trial referrals
Reason for withdrawal
时间窗: 12 weeks following receipt of treatment
Assessed by an open-ended question, "What was the reason for discontinuing your participation?" administered by a study staff during a phone interview
M-DMT intervention credibility and expectancy
时间窗: 1 week
Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility)
Treatment Fidelity
时间窗: 1-12 weeks
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)
Treatment satisfaction and acceptability: Likert-scale survey
时间窗: 12 weeks post-randomization
via Likert-scale surveys; on scale of 1 to 5, 1 being not satisfied; 5 being very satisfied (i.e higher number, better outcome).
M-DMT intervention acceptability
时间窗: 12 weeks
Exit interview based on an interview protocol developed by the researcher
Adverse Event
时间窗: 1 -12 weeks
Number of adverse events
次要结局
- Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a(Change from Baseline pain intensity at 6, 12, and 24-week time points)
- Pain interference: PROMIS® Pain Interference -8a(Change from Baseline pain interference at 6, 12, and 24-week time points)
- Chronic pain acceptance: Chronic Pain Acceptance Questionnaire(Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points)
- Mindfulness(Change from Baseline mindfulness at 6, 12, and 24-week time points)
- Physical activity (Accelerometry data)(Change from Baseline physical activity at 12, and 24-week time points)
- Physical activity (Self-report data)(Change from Baseline physical activity at 6, 12, and 24-week time points)