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.
Condition or disease | Intervention/treatment | Phase |
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Chronic Low-back Pain | Behavioral: Mindfulness-based dance/movement therapy (M-DMT) Behavioral: Chronic pain social support group | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain |
Actual Study Start Date : | April 1, 2019 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | July 2022 |
Arm | Intervention/treatment |
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Experimental: 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.
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Behavioral: Mindfulness-based dance/movement therapy (M-DMT)
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.
Other Name: Dance/Movement Therapy
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Active Comparator: 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.
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Behavioral: Chronic pain 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. |
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria:
Contact: Minjung Shim, PhD | 267-359-5592 | ms344@drexel.edu | |
Contact: Adam Gonzalez, PhD | 631-632-8675 | adam.gonzalez@stonybrookmedicine.edu |
United States, Pennsylvania | |
Drexel Universitsy | Recruiting |
Philadelphia, Pennsylvania, United States, 19102 | |
Contact: Minjung Shim, PhD 267-359-5592 ms344@drexel.edu | |
Contact: Bradt, PhD |
Principal Investigator: | Minjung Shim, PhD | Drexel University | |
Principal Investigator: | Adam Gonzalez, PhD | Stony Brook University |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 29, 2019 | ||||||||
First Posted Date ICMJE | June 14, 2019 | ||||||||
Last Update Posted Date | April 15, 2021 | ||||||||
Actual Study Start Date ICMJE | April 1, 2019 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain | ||||||||
Official Title ICMJE | Mindfulness-based Dance/Movement Therapy for Chronic Low Back Pain | ||||||||
Brief Summary |
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. |
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Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Low-back Pain | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
64 | ||||||||
Original Estimated Enrollment ICMJE |
72 | ||||||||
Estimated Study Completion Date ICMJE | July 2022 | ||||||||
Estimated Primary Completion Date | December 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03986489 | ||||||||
Other Study ID Numbers ICMJE | 1810006694 7R34AT009555-02 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Drexel University | ||||||||
Study Sponsor ICMJE | Drexel University | ||||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Drexel University | ||||||||
Verification Date | December 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |