Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain

Официальное название

Effects of a Mobile App-Based Mindfulness Intervention in Persons with Spinal Cord Injury and Chronic Pain: a Randomized Controlled Trial

Обзор

The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.

Вмешательства

• Другое Mindfulness meditation (MM) Intervention
  Participants will be asked to download the Mindfulness Coach app that provides simple instructions and brief meditation exercises.This is a a gradual training program of 14 levels which will be completed in the first 2-3 weeks. Each level provides short readings about mindfulness and one or two guided meditations (a silent "seated practice" for increasing lengths of time plus typically an additional 8-13-minute meditation). As participants progress through the levels, they earn "badges" displaye
• Другое Health Education Active Control Intervention
  Participants will be asked to download and use the free TED Talk app, which will have 50 TED talk videos related to health that range from 3-20 minutes. Participants will be asked to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week and complete weekly logs of the TED Talk app use.

Первичные конечные точки

• Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS). [Срок оценки: baseline , post-intervention (6 weeks after baseline)]

Вторичные конечные точки (3)

• Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale [Срок оценки: baseline , post-intervention (6 weeks after baseline)]
• Change in depression as assessed by the Patient Health Questionnaire (PHQ-9) [Срок оценки: baseline , post-intervention (6 weeks after baseline)]
• Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7) [Срок оценки: baseline , post-intervention (6 weeks after baseline)]

Критерии участия

Критерии включения

• Traumatic SCI of at least 6 months duration
• Chronic pain \[defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale\]
• Understand spoken and written English sufficiently to provide informed consent, participate in the intervention and complete study surveys

Критерии исключения

• Lack of daily internet access
• inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study
• Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations
• Use of any meditation more than once a week in the last 3 months
• Inability to provide or obtain an email address for registration to the AC intervention and/or communication with study staff
• inability to provide a phone number for communication with study staff

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06891989 · HSC-MS-25-0005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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