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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain, Migraine, Chronic Pain Syndrome

Intervention / Treatment
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* Behavioral: Mind-body mobile application


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized into one of two groups: control (usual care, waitlisted) or intervention group (6-week mind-body mobile application use). Randomization will be stratified on pain intensity and gender using computer generated block randomization to create varying block sizes of 4 and 8.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mind-body mobile application<br>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. | Behavioral: Mind-body mobile application<br>* 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.<br>|
| No Intervention: Control<br>Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Brief Pain Inventory-short form (BPI-SF) | Measures self reported pain intensity (on average); Pain interference | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PROMIS Pain Intensity short form | Measures self reported pain intensity over 7 days | 6 weeks | 
| Change in PROMIS Pain Interference short form 8a | Measures self reported pain interference in daily activities (over 7 days) | 6 and 12 weeks | 
| Change in Pain Catastrophizing Questionnaire (PCS) | Measures thoughts and perceptions of pain | 6 and 12 weeks | 
| Change in DASS-21 (Depression, Anxiety, and Stress Scale) | Measures self reported emotional states | 6 and 12 weeks | 
| Change in Quality of Life Short Form 12 (SF-12) | Measures self-reported impact of health on daily life | 6 and 12 weeks | 
| Change in Brief Pain Inventory-short form (BPI-SF) | Measures self reported pain intensity; Pain interference (over past 24 hours) | 12 weeks | 
| Change in PROMIS Pain Intensity short form | Measures self reported pain intensity over 7 days | 12 weeks | 
| Medication use (daily) | Self-reported quantify of medication used (dosage, number of pills in 24 hours) | 6 weeks | 
| Medication use (occasional) | Self-reported quantify of medication used (dosage, number of pills in 7 days) | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic pain, mind-body, mobile application