Танцевально-двигательная терапия на основе осознанности при хронической боли в пояснице
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.
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19102
- Drexel Universitsy
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
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Экспериментальный: 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.
Другие имена:
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Активный компаратор: 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. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Feasibility of Recruitment: Number of participants eligible
Временное ограничение: Baseline
|
Number of participants eligible for randomization to the study intervention |
Baseline
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Recruitment Rate
Временное ограничение: Baseline
|
Proportion of participants randomized relative to total trial referrals |
Baseline
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Recruitment time
Временное ограничение: Baseline
|
Number of participate enrolled per month |
Baseline
|
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Feasibility of recruiting male participants: Proportion of male participant enrolled
Временное ограничение: Baseline
|
Proportion of male participant enrolled to the study |
Baseline
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Treatment Completion Rate
Временное ограничение: 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
Временное ограничение: 24 weeks
|
Proportion of participants who complete follow-up questionnaires |
24 weeks
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Reason for withdrawal
Временное ограничение: 12 weeks following receipt of treatment
|
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
Временное ограничение: 1 week
|
Credibility/Expectancy Questionnaire (range 3-27; higher scores reflect greater treatment expectancy and rationale credibility) |
1 week
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Treatment Fidelity
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 1 -12 weeks
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Number of adverse events |
1 -12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Pain intensity: PROMIS® Pain Intensity-Short Form (SF)3a
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Physical Function
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Minjung Shim, PhD, Drexel University
- Главный следователь: Adam Gonzalez, PhD, Stony Brook University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 1810006694
- 7R34AT009555-02 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
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