NCT05090683

Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: University of the Fraser Valley · Academic / Other
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

We are investigating the effects of a mind-body based mobile application on the experience of chronic pain. Participants meeting our criteria for chronic pain (confirmed via self-report) will complete an online baseline questionnaire. Eligible participants will be enrolled in the study and randomized into control (usual care, waitlisted) or intervention group (6-week mind-body based mobile application intervention). Randomization will be stratified by pain intensity and gender using computer-generated block randomization to create varying block sizes of 4 and 8. We will run the trial in multiple cohorts in series to obtain desired sample size. All participants will complete online questionnaires at baseline and post-intervention at 6 weeks that measure pain intensity, interference with daily living, pain perceptions, mental health outcomes, and medication use. Participants will also complete weekly questionnaires on weeks 2 to 6 to gauge frequency of application usage (intervention) or other pain treatments (control). Participants in the intervention group will be asked to repeat the follow-up questionnaire at 12-weeks.

Detailed description

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

Conditions

• Chronic Pain
• Migraine
• Chronic Pain Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Mind-body mobile application	Self-directed; Study team will recommend daily use of mobile app for 6 weeks with a minimum of 4 times/week usage of mobile app for 6 weeks. Frequency will be monitored via weekly surveys.

Timeline

• Start date: 2021-10-15
• Primary completion: 2022-06-15
• Completion: 2022-07-15
• First posted: 2021-10-25
• Last updated: 2025-01-29
• Results posted: 2025-01-29

Locations

1 site across 1 country: Canada