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

University of the Fraser Valley

Status: Completed

Conditions: Chronic Pain Syndrome; Chronic Pain; Migraine

Treatments: Behavioral: Mind-body mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT05090683

100820

Details and patient eligibility

About

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.

Full description

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

Enrollment: 198 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.

Exclusion criteria

• Individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application.
• Individuals reporting any of the following psychiatric illness: schizophrenia, dissociative or personality disorders, bipolar disorder.
• Individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis.
• Individuals reporting substance use disorder (within the last 6 months).
• Individuals that have previously used mind-body apps for the treatment of chronic pain.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Mind-body mobile application

Experimental group

Description:

Participants are asked to engage with a user-guided mobile application (app) that employs mind-based techniques that include: expressive writing, meditation, cognitive behavioural therapy, and pain education. The app also includes access to podcasts that focus on pain counselling and pain education.

Treatment:

Behavioral: Mind-body mobile application

Control

No Intervention group

Description:

Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.