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

NCT ID: NCT03986489

Last Updated: 2021-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2022-07-31

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.

Detailed Description

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Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mindfulness-based dance/movement therapy (M-DMT)

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Chronic pain social support group

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Dance/Movement Therapy

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Stony Brook University

OTHER

Sponsor Role collaborator

Drexel University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minjung Shim, PhD

Role: PRINCIPAL_INVESTIGATOR

Drexel University

Adam Gonzalez, PhD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

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Drexel Universitsy

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Minjung Shim, PhD

Role: CONTACT

267-359-5592

Adam Gonzalez, PhD

Role: CONTACT

631-632-8675

Facility Contacts

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Minjung Shim, PhD

Role: primary

267-359-5592

Bradt, PhD

Role: backup

Other Identifiers

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7R34AT009555-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1810006694

Identifier Type: -

Identifier Source: org_study_id

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