Mindfulness-gebaseerde dans-/bewegingstherapie voor chronische lage rugpijn
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19102
- Drexel Universitsy
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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. |
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.
Andere namen:
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Actieve vergelijker: 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. |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility of Recruitment: Number of participants eligible
Tijdsspanne: Baseline
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Number of participants eligible for randomization to the study intervention |
Baseline
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Recruitment Rate
Tijdsspanne: Baseline
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Proportion of participants randomized relative to total trial referrals |
Baseline
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Recruitment time
Tijdsspanne: Baseline
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Number of participate enrolled per month |
Baseline
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Feasibility of recruiting male participants: Proportion of male participant enrolled
Tijdsspanne: Baseline
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Proportion of male participant enrolled to the study |
Baseline
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Treatment Completion Rate
Tijdsspanne: 12 weeks following receipt of treatment
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We expect 80% of participants to complete at least 9/12 M-DMT sessions |
12 weeks following receipt of treatment
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Retention Rate
Tijdsspanne: 24 weeks
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Proportion of participants who complete follow-up questionnaires |
24 weeks
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Reason for withdrawal
Tijdsspanne: 12 weeks following receipt of treatment
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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
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M-DMT intervention credibility and expectancy
Tijdsspanne: 1 week
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Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility) |
1 week
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Treatment Fidelity
Tijdsspanne: 1-12 weeks
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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
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Treatment satisfaction and acceptability: Likert-scale survey
Tijdsspanne: 12 weeks post-randomization
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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
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M-DMT intervention acceptability
Tijdsspanne: 12 weeks
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Exit interview based on an interview protocol developed by the researcher |
12 weeks
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Adverse Event
Tijdsspanne: 1 -12 weeks
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Number of adverse events |
1 -12 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a
Tijdsspanne: Change from Baseline pain intensity at 6, 12, and 24-week time points
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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
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Pain interference: PROMIS® Pain Interference -8a
Tijdsspanne: Change from Baseline pain interference at 6, 12, and 24-week time points
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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
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Chronic pain acceptance: Chronic Pain Acceptance Questionnaire
Tijdsspanne: Change from Baseline chronic pain acceptance at 6, 12, and 24-week time points
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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
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Mindfulness
Tijdsspanne: Change from Baseline mindfulness at 6, 12, and 24-week time points
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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
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Physical activity (Accelerometry data)
Tijdsspanne: Change from Baseline physical activity at 12, and 24-week time points
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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
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Physical activity (Self-report data)
Tijdsspanne: Change from Baseline physical activity at 6, 12, and 24-week time points
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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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Physical Function
Tijdsspanne: Change from Baseline physical function at 6, 12, and 24-week time points
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PROMIS® Physical function-20a (A 5-point (5= without any difficulty to 1= Unable to do) rating scale is used in each of the 20 items; higher values reflect higher abilities to physically function |
Change from Baseline physical function at 6, 12, and 24-week time points
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Depression
Tijdsspanne: Change from Baseline depression at 6, 12, and 24-week time points
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PROMIS® Emotional Distress-Depression-SF 4a (A 5-point (1= Never to 5= Always) rating scale is used in each of the 4 items; higher values reflect higher levels of depression |
Change from Baseline depression at 6, 12, and 24-week time points
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Sleep Disturbance
Tijdsspanne: Change from Baseline sleep disturbance at 6, 12, and 24-week time points
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PROMIS® Sleep Disturbance-4a (A 5-point (5= Very poor to 1= Very good) rating scale is used in each of the 4 items; higher values reflect higher levels of sleep disturbances |
Change from Baseline sleep disturbance at 6, 12, and 24-week time points
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Pain Catastrophizing: Pain Catastrophizing Scale
Tijdsspanne: Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
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Pain Catastrophizing Scale - short form(SF)-4a (A 4-point (0= Not at all to 4= All the time) rating scale is used in each of the 4 items; higher scores reflect greater pain catastrophizing |
Change from Baseline pain catastrophizing at 6, 12, and 24-week time points
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Kinesiophobia
Tijdsspanne: Change from Baseline kinesiophobia at 6, 12, and 24-week time points
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Tampa Scale of Kinesiophobia (A 4-point (1= Strongly disagree to 4= Strongly agree) rating scale is used in each of the 11 items; higher values reflect higher levels of kinesiophobia |
Change from Baseline kinesiophobia at 6, 12, and 24-week time points
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Patient Perception of Change
Tijdsspanne: 12 weeks
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Score on single item Patient Global Impression of Change Rating (range: 1 (No change) to 7 (a great deal better)) |
12 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Minjung Shim, PhD, Drexel University
- Hoofdonderzoeker: Adam Gonzalez, PhD, Stony Brook University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 1810006694
- 7R34AT009555-02 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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