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

University of the Fraser Valley

Status: Not yet enrolling

Conditions: Chronic Pain Syndrome; Chronic Pain; Migraine

Treatments: Behavioral: Mind-body mobile application and guided movement

Study type: Interventional

Funder types: Other

Identifiers

NCT07143396

101806

Details and patient eligibility

About

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).

Full description

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

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Mind-body mobile application and guided movement

Experimental group

Description:

Participants are asked to engage (minimum 4x per week) with a user-guided mobile application (app) that employs mind-body techniques including expressive writing, meditation, cognitive behavioural therapy, and pain education. The app also includes access to podcasts that focus on pain counselling and pain education. Participants are also asked to follow (3x per week) an audio-guided somatic education program (light-intensity graded movement).

Treatment:

Behavioral: Mind-body mobile application and guided movement