Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain

Study Overview
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Brief Summary
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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.

Official Title
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Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Mindfulness-based dance/movement therapy (M-DMT)
* Behavioral: Chronic pain social support group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness-based dance/movement therapy<br>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. | Behavioral: Mindfulness-based dance/movement therapy (M-DMT)<br>* 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.<br>* Other names: Dance/Movement Therapy;|
| Active Comparator: Chronic pain social support group<br>Participants assigned to the control condition will participate in a 12-session (90-minute session/week) online social support group. | Behavioral: Chronic pain social support group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Recruitment: Number of participants eligible | Number of participants eligible for randomization to the study intervention | Baseline | 
| Recruitment Rate | Proportion of participants randomized relative to total trial referrals | Baseline | 
| Recruitment time | Number of participate enrolled per month | Baseline | 
| Feasibility of recruiting male participants: Proportion of male participant enrolled | Proportion of male participant enrolled to the study | Baseline | 
| Treatment Completion Rate | We expect 80% of participants to complete at least 9/12 M-DMT sessions | 12 weeks following receipt of treatment | 
| Retention Rate | Proportion of participants who complete follow-up questionnaires | 24 weeks | 
| Reason for withdrawal | 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 | 
| M-DMT intervention credibility and expectancy | Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility) | 1 week | 
| Treatment Fidelity | 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 | 
| Treatment satisfaction and acceptability: Likert-scale survey | 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 | 
| M-DMT intervention acceptability | Exit interview based on an interview protocol developed by the researcher | 12 weeks | 
| Adverse Event | Number of adverse events | 1 -12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a | 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 | 
| Pain interference: PROMIS® Pain Interference -8a | 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 | 
| Chronic pain acceptance: Chronic Pain Acceptance Questionnaire | 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 | 
| Mindfulness | 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 | 
| Physical activity (Accelerometry data) | 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 | 
| Physical activity (Self-report data) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dance/movement therapy, Mindfulness-based dance/movement therapy, Chronic pain management, Creative Arts Therapies, Non-pharmacological intervention, Online intervention