Clinical trial NCT05090683: Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.
Official title: Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Migraine
Chronic Pain Syndrome
Keywords: chronic pain
mind-body
mobile application
Lead sponsor: University of the Fraser Valley
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 198
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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)

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.

Primary outcomes:
measure: Brief Pain Inventory-short Form (BPI-SF)
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Patient Reported Outcome Measurement Information System (PROMIS) Short Form for Pain Intensity on Average
timeFrame: baseline, 6 weeks
measure: Patient Reported Outcome Measurement Information System (PROMIS) Short Form 8a Pain Interference
timeFrame: baseline, 6 weeks
measure: Pain Catastrophizing Questionnaire (PCS)
timeFrame: baseline, 6 weeks
measure: DASS-21 (Depression, Anxiety, and Stress Scale)
timeFrame: baseline, 6 weeks
measure: 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)
timeFrame: baseline, 6 weeks
measure: Brief Pain Inventory-short Form (BPI-SF)
timeFrame: 12 weeks
measure: PROMIS Pain Intensity Short Form
timeFrame: 12 weeks
measure: Medication Use
timeFrame: 6 weeks
measure: PROMIS Pain Interference Short Form 8a
timeFrame: 12 weeks
measure: Pain Catastrophizing Questionnaire (PCS)
timeFrame: 12 weeks
measure: 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)
timeFrame: 12 weeks
measure: DASS-21 (Depression, Anxiety, Stress Scale - 21 Items)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Chilliwack
country: Canada
facility: University of the Fraser Valley
state: British Columbia
Study officials:
affiliation: University of the Fraser Valley
name: Cynthia J Thomson, PhD
role: PRINCIPAL_INVESTIGATOR
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