Evaluation of a Mind-Body Based Approach for Chronic Pain Treatment

Официальное название

Evaluation of a Mind-Body Application in Combination With a Graded Movement Program for the Treatment of Chronic Pain

Обзор

The investigators are evaluating the effects of a mind-body mobile application, in combination with a guided movement program, on the experience of chronic pain. Participants meeting the criteria for chronic/persistent pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will take part in an intervention that involves use of a 6-week free trial of a mind-body focused mobile application in combination with virtual asynchronous audio-guided somatic education sessions (gentle movement). External data from a usual care control arm and a mobile-app-only arm from a previous study by the same research team, National Clinical Trials (NCT) registry number NCT05090683, will be used for comparison with the current combined intervention. All participants will complete online surveys at the start of the study and after 6 weeks to measure pain intensity and interference (primary outcomes), mental health outcomes (depression, anxiety, stress), pain-related thoughts (pain catastrophizing), quality of life, and fear of movement (secondary outcomes). From weeks 2 to 6, participants will fill out weekly surveys to track how often they engage with each: the somatic education (gentle movement) program and the mobile app. Participants will also complete a follow-up survey at 12 weeks (6 weeks post-intervention conclusion).

Подробное описание

See protocol for more details. (submitted at time of registration)

Вмешательства

• Поведенческое Mind-body mobile application and guided movement
  Self-directed: The study team recommends daily use of the mobile app for 6 weeks, with a minimum of 4 times per week, and engagement with the somatic education program at least 3 times per week for 6 weeks. Frequency of app usage and somatic education engagement will be monitored via weekly surveys.

Первичные конечные точки

• Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity [Срок оценки: Baseline, 6 weeks.]
• Change in Brief Pain Inventory-short form (BPI-SF) Pain Interference [Срок оценки: Baseline, 6 weeks.]

Вторичные конечные точки (10)

• Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a [Срок оценки: Baseline, 6 weeks, 12 weeks]
• Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a [Срок оценки: Baseline, 6 weeks, 12 weeks]
• Change in Pain Catastrophizing Questionnaire (PCS) [Срок оценки: Baseline, 6 and 12 weeks]
• Change in Depression, Anxiety, and Stress Scale (DASS-21) [Срок оценки: Baseline, 6 and 12 weeks]
• Change in Quality of Life Short Form 12 (SF-12) Physical Component Score [Срок оценки: Baseline, 6 and 12 weeks]
• Change in Quality of Life Short Form 12 (SF-12) Mental Component Score [Срок оценки: Baseline, 6 and 12 weeks]
• Change in Tampa Scale of Kinesiophobia Questionnaire (TSK) [Срок оценки: Baseline, 6 and 12 weeks]
• Change in Brief Pain Inventory Pain Severity Composite Score [Срок оценки: baseline, 6 weeks, 12 weeks]
• Change in Brief Pain Inventory Pain Severity (from baseline to 12 weeks) [Срок оценки: baseline, 12 weeks]
• Change in Brief Pain Inventory Interference (from baseline to 12 weeks) [Срок оценки: baseline, 12 weeks]

Критерии участия

Критерии включения

• Participants aged 19 to 75 years with chronic pain
• Chronic pain is defined as having non-malignant chronic or persistent pain for at least 6 months.
• Participants must experience pain at least half the days in the last 6 months.
• Pain can include bodily pain or head (migraine) pain
• Participants must have access to an electronic device
• Participants must be willing to engage in weekly somatic education activities

Критерии исключения

• Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application.
• Individuals reporting substance use disorder (within the last 6 months).
• Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis.
• Individuals with previous experience with the mind-body app under study (Note: use of "Calm" or another meditation-only app is not an exclusion).
• Individuals with current regular (at least once a week) engagement with a somatic movement program (e.g., Feldenkrais, Hanna Somatics, Somatic Yoga, Tai Chi, Pilates)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Канада · 1 центр

• University of the Fraser Valley — Chilliwack

Публикации

• Roelofs J, Goubert L, Peters ML, Vlaeyen JW, Crombez G. The Tampa Scale for Kinesiophobia: further examination of psychometric properties in patients with chronic low back pain and fibromyalgia. Eur J Pain. 2004 Oct;8(5):495-502. doi: 10.1016/j.ejpain.2003.11.016. PMID 15324781
• Kean J, Monahan PO, Kroenke K, Wu J, Yu Z, Stump TE, Krebs EE. Comparative Responsiveness of the PROMIS Pain Interference Short Forms, Brief Pain Inventory, PEG, and SF-36 Bodily Pain Subscale. Med Care. 2016 Apr;54(4):414-21. doi: 10.1097/MLR.0000000000000497. PMID 26807536
• Osman A, Barrios FX, Kopper BA, Hauptmann W, Jones J, O'Neill E. Factor structure, reliability, and validity of the Pain Catastrophizing Scale. J Behav Med. 1997 Dec;20(6):589-605. doi: 10.1023/a:1025570508954. PMID 9429990
• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38. PMID 8080219
• Gatchel RJ, Peng YB, Peters ML, Fuchs PN, Turk DC. The biopsychosocial approach to chronic pain: scientific advances and future directions. Psychol Bull. 2007 Jul;133(4):581-624. doi: 10.1037/0033-2909.133.4.581. PMID 17592957
• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. PMID 8628042
• Devan H, Farmery D, Peebles L, Grainger R. Evaluation of Self-Management Support Functions in Apps for People With Persistent Pain: Systematic Review. JMIR Mhealth Uhealth. 2019 Feb 12;7(2):e13080. doi: 10.2196/13080. PMID 30747715
• Schopflocher D, Taenzer P, Jovey R. The prevalence of chronic pain in Canada. Pain Res Manag. 2011 Nov-Dec;16(6):445-50. doi: 10.1155/2011/876306. PMID 22184555

Идентификаторы

NCT: NCT07143396 · 101806

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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