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

Drexel University64 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Chronic Low-back Pain

Interventions

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 groupBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Feasibility of Recruitment: Number of participants eligible

Number of participants eligible for randomization to the study intervention

Time frame: Baseline

Recruitment Rate

Proportion of participants randomized relative to total trial referrals

Time frame: Baseline

Recruitment time

Number of participate enrolled per month

Time frame: Baseline

Feasibility of recruiting male participants: Proportion of male participant enrolled

Proportion of male participant enrolled to the study

Time frame: Baseline

Treatment Completion Rate

We expect 80% of participants to complete at least 9/12 M-DMT sessions

Time frame: 12 weeks following receipt of treatment

Retention Rate

Proportion of participants who complete follow-up questionnaires

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: 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).

Time frame: 12 weeks post-randomization

M-DMT intervention acceptability

Exit interview based on an interview protocol developed by the researcher

Time frame: 12 weeks

Adverse Event

Number of adverse events

Time frame: 1 -12 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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)

Time frame: Change from Baseline physical activity at 6, 12, and 24-week time points

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts