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

NCT03986489 | Unknown DMC

• 2 other identifiers: 18100066947R34AT009555-02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Dance/movement therapy; Mindfulness-based dance/movement therapy; Chronic pain management; Creative Arts Therapies; Non-pharmacological intervention; Online intervention

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (6)

• 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

Other Outcomes (6)

• Physical Function

  Change from Baseline physical function at 6, 12, and 24-week time points

• Depression

  Change from Baseline depression at 6, 12, and 24-week time points

• Sleep Disturbance

  Change from Baseline sleep disturbance at 6, 12, and 24-week time points

Study Arms (2)

Mindfulness-based dance/movement therapy

EXPERIMENTAL

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)

Chronic pain social support group

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Dance/Movement Therapy

Mindfulness-based dance/movement therapy

Chronic pain social support group 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.

Chronic pain social support group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Stony Brook University: collaborator

Study Sites (1)

Drexel Universitsy

Philadelphia, Pennsylvania, 19102, United States

RECRUITING

Study Officials

• Minjung Shim, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

• Adam Gonzalez, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minjung Shim, PhD

CONTACT

267-359-5592; ms344@drexel.edu

Adam Gonzalez, PhD

CONTACT

631-632-8675; adam.gonzalez@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 14, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: July 1, 2022
• Last Updated: April 15, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)