N/A
N=198
Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.
Chronic Pain · Migraine · Chronic Pain Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT05090683 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Brief Pain Inventory-short Form (BPI-SF) — 5.33; 5.35; 4.51; 5.16 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mind-body mobile application (Behavioral)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of the Fraser Valley
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brief Pain Inventory-short Form (BPI-SF) |
4.60; 4.85 | — |
| SECONDARY Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average |
2.99; 3.22; 2.81; 3.08 | — |
| SECONDARY Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference |
28.22; 29.01; 16.71; 19.63 | — |
| SECONDARY Pain Catastrophizing Questionnaire (PCS) |
16.46 | — |
| SECONDARY DASS-21 (Depression, Anxiety, and Stress Scale) |
14.57; 14.52; 11.97; 14.85; 9.89; 8.92 | — |
| SECONDARY Quality of Life Short Form 12 (SF-12) Physical (PCS-12) and Mental (MCS-12) Component Summary Scores (Z-scores; Normalized Based on US General Population) |
27.66; 50.20 | — |
| SECONDARY Brief Pain Inventory-short Form (BPI-SF) |
4.60; 4.85 | — |
| SECONDARY PROMIS Pain Intensity Short Form |
2.74 | — |
| SECONDARY Medication Use |
48; 59; 11; 29; 20; 27 | — |
| SECONDARY PROMIS Pain Interference Short Form 8a |
24.34 | — |
| SECONDARY Pain Catastrophizing Questionnaire (PCS) |
16.46 | — |
| SECONDARY Quality of Life Short Form 12 (SF-12) Physical (PCS-12) and Mental (MCS-12) Component Summary Scores (Z-scores; Normalized Based on US General Population) |
27.66; 50.20 | — |
| SECONDARY DASS-21 (Depression, Anxiety, Stress Scale - 21 Items) |
6.32; 4.20; 7.58 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05090683). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.