Evaluation of a Mind-Body Based Approach for Chronic Pain Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-75
SponsorUniversity of the Fraser Valley
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial design
Design model
Single group
Treatments tested in this trial
Mind-body mobile application and guided movement
BehavioralSelf-directed: The study team recommends daily use of the mobile app for 6 weeks, with a minimum of 4 times per week, and engagement with the somatic education program at least 3 times per week for 6 weeks. Frequency of app usage and somatic education engagement will be monitored via weekly surveys.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Mind-body mobile application and guided movementExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Brief Pain Inventory-short form (BPI-SF) Pain Severity
Measures self reported pain severity (over past 24 hours). BPI Pain Severity: single item scale within larger Brief Pain Inventory tool that asses pain "average" pain severity. Item scale ranges from 0 to 10. 0 = "no pain", 10 = "pain as bad as you can imagine". Higher scores indicate worse outcome (pain severity), lower scores indicate better outcome. Item range = (0,10).
Time frame
Baseline, 6 weeks.2
Change in Brief Pain Inventory-short form (BPI-SF) Pain Interference
Item 9 on the BPI measures interference with daily living. There are 7 items (reflecting seven daily activities) and each is scored on 11-point scales from 0 = "does not interfere" to 10 = "completely interferes" for interference with activities of daily living. Pain interference score is calculated as an average of the 7 items, with a range from 0 to 10. Higher scores represent worse outcomes (higher interference).
Time frame
Baseline, 6 weeks.Secondary outcomes
1
Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Intensity short form 3a
Measures self reported pain intensity over the past 7 days "on average" and "at its worst" along with an item to assess pain intensity "now". The three items are added together to produce a raw score which can be converted to a t-score. Each item uses 5-pt Likert scale from 1 = "had no pain" to 5 = "very severe". Raw scores range from 3 to 15. Higher scores indicate worse outcomes.
Time frame
Baseline, 6 weeks, 12 weeks2
Change in Patient Reported Outcome Measurement Information System (PROMIS) Pain Interference short form 8a
Measures self reported pain interference in daily activities (over 7 days). 8 items are added together for a raw score, which can then be converted to a t-score. Each item uses 5-pt Likert scale from 1 = "not at all" to 5 = "very much" (regarding pain interference). Raw scores range from 8 to 40. Higher scores indicate worse outcomes.
Time frame
Baseline, 6 weeks, 12 weeks3
Change in Pain Catastrophizing Questionnaire (PCS)
Measures thoughts and perceptions of pain, 13 items, scored using 5-pt Likert scale 0 = "not at all" to 4 = "all the time". Scores are the sum of all items. min score = 0; max score = 52. Higher scores indicate worse outcomes.
Time frame
Baseline, 6 and 12 weeks4
Change in Depression, Anxiety, and Stress Scale (DASS-21)
Measures self reported emotional states, three subscales: depression, anxiety, stress (each 7 items) Items scored on 4-point Likert scale: 0 = "did not apply to me at all" to 3 = "applied to me very much or most of the time". Scores for each subscale are summed. Scores are then multiplied by 2 to calculate final score for each subscale. Scale ranges for each subscale is from 0 to 42 (after doubling of scores). Higher scores indicate worse outcomes.
Time frame
Baseline, 6 and 12 weeksSponsors and contacts
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Source ClinicalTrials.gov
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