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

Primary Purpose

Chronic Pain, Migraine, Chronic Pain Syndrome

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mind-body mobile application
Sponsored by
University of the Fraser Valley
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring chronic pain, mind-body, mobile application

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of the Fraser Valley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mind-body mobile application

Control

Arm Description

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.

Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.

Outcomes

Primary Outcome Measures

Change in Brief Pain Inventory-short form (BPI-SF)
Measures self reported pain intensity (on average); Pain interference

Secondary Outcome Measures

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

Full Information

First Posted
October 13, 2021
Last Updated
November 9, 2022
Sponsor
University of the Fraser Valley
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1. Study Identification

Unique Protocol Identification Number
NCT05090683
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
December 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of the Fraser Valley

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Migraine, Chronic Pain Syndrome
Keywords
chronic pain, mind-body, mobile application

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Allocation
Randomized
Enrollment
197 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mind-body mobile application
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants are asked to continue with usual care for pain treatments. They are asked not to start any new forms of treatment.
Intervention Type
Behavioral
Intervention Name(s)
Mind-body mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Brief Pain Inventory-short form (BPI-SF)
Description
Measures self reported pain intensity (on average); Pain interference
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in PROMIS Pain Intensity short form
Description
Measures self reported pain intensity over 7 days
Time Frame
6 weeks
Title
Change in PROMIS Pain Interference short form 8a
Description
Measures self reported pain interference in daily activities (over 7 days)
Time Frame
6 and 12 weeks
Title
Change in Pain Catastrophizing Questionnaire (PCS)
Description
Measures thoughts and perceptions of pain
Time Frame
6 and 12 weeks
Title
Change in DASS-21 (Depression, Anxiety, and Stress Scale)
Description
Measures self reported emotional states
Time Frame
6 and 12 weeks
Title
Change in Quality of Life Short Form 12 (SF-12)
Description
Measures self-reported impact of health on daily life
Time Frame
6 and 12 weeks
Title
Change in Brief Pain Inventory-short form (BPI-SF)
Description
Measures self reported pain intensity; Pain interference (over past 24 hours)
Time Frame
12 weeks
Title
Change in PROMIS Pain Intensity short form
Description
Measures self reported pain intensity over 7 days
Time Frame
12 weeks
Title
Medication use (daily)
Description
Self-reported quantify of medication used (dosage, number of pills in 24 hours)
Time Frame
6 weeks
Title
Medication use (occasional)
Description
Self-reported quantify of medication used (dosage, number of pills in 7 days)
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia J Thomson, PhD
Organizational Affiliation
University of the Fraser Valley
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of the Fraser Valley
City
Chilliwack
State/Province
British Columbia
ZIP/Postal Code
V2R0N3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.

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