We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05090683
Recruitment Status : Active, not recruiting
First Posted : October 25, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
University of the Fraser Valley

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.


Condition or disease Intervention/treatment Phase
Chronic Pain Migraine Chronic Pain Syndrome Behavioral: Mind-body mobile application Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Masking Description: Participants in the control group will be aware that they have are serving as controls that have been wait-listed for access to the mobile application.
Primary Purpose: Treatment
Official Title: Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.
Actual Study Start Date : October 15, 2021
Actual Primary Completion Date : June 15, 2022
Estimated Study Completion Date : December 15, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Mind-body mobile application
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
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.

No Intervention: Control
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.



Primary Outcome Measures :
  1. Change in Brief Pain Inventory-short form (BPI-SF) [ Time Frame: 6 weeks ]
    Measures self reported pain intensity (on average); Pain interference


Secondary Outcome Measures :
  1. Change in PROMIS Pain Intensity short form [ Time Frame: 6 weeks ]
    Measures self reported pain intensity over 7 days

  2. Change in PROMIS Pain Interference short form 8a [ Time Frame: 6 and 12 weeks ]
    Measures self reported pain interference in daily activities (over 7 days)

  3. Change in Pain Catastrophizing Questionnaire (PCS) [ Time Frame: 6 and 12 weeks ]
    Measures thoughts and perceptions of pain

  4. Change in DASS-21 (Depression, Anxiety, and Stress Scale) [ Time Frame: 6 and 12 weeks ]
    Measures self reported emotional states

  5. Change in Quality of Life Short Form 12 (SF-12) [ Time Frame: 6 and 12 weeks ]
    Measures self-reported impact of health on daily life

  6. Change in Brief Pain Inventory-short form (BPI-SF) [ Time Frame: 12 weeks ]
    Measures self reported pain intensity; Pain interference (over past 24 hours)

  7. Change in PROMIS Pain Intensity short form [ Time Frame: 12 weeks ]
    Measures self reported pain intensity over 7 days

  8. Medication use (daily) [ Time Frame: 6 weeks ]
    Self-reported quantify of medication used (dosage, number of pills in 24 hours)

  9. Medication use (occasional) [ Time Frame: 6 weeks ]
    Self-reported quantify of medication used (dosage, number of pills in 7 days)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05090683


Locations
Layout table for location information
Canada, British Columbia
University of the Fraser Valley
Chilliwack, British Columbia, Canada, V2R0N3
Sponsors and Collaborators
University of the Fraser Valley
Investigators
Layout table for investigator information
Principal Investigator: Cynthia J Thomson, PhD University of the Fraser Valley
  Study Documents (Full-Text)

Documents provided by University of the Fraser Valley:
Publications:

Layout table for additonal information
Responsible Party: University of the Fraser Valley
ClinicalTrials.gov Identifier: NCT05090683    
Other Study ID Numbers: 100820
First Posted: October 25, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of the Fraser Valley:
chronic pain
mind-body
mobile application
Additional relevant MeSH terms:
Layout table for MeSH terms
Chronic Pain
Pain
Neurologic Manifestations