Evaluation of a Mind-body Based Application for the Treatment of Chronic/Persistent Pain.
Phase: NA
Conditions: Chronic Pain, Migraine, Chronic Pain Syndrome
Sponsor: University of the Fraser Valley

 
 
 
 
 
 
Protocol: Evaluation of a mind-body based application for the treatment of 
chronic/persistent pain. 
  
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
Principal Investigator:  
Cynthia J Thomson  
Faculty of Health Science 
University of the Fraser Valley 
45190 Caen Avenue 
Chilliwack, BC Canada V2R 0N3 
Tel: 604-792-0025 x2518  
Email: cynthia.thomson@ufv.ca  
  
Co-Investigator: Luisa V. Giles;   
Research Assistant: Hanna Pahl  
 
University of the Fraser Valley  
ID: #1008820   
NCT:   
Protocol version date: October 12, 2021  
 
  

Evaluation of a mind-body based application for the treatment of chronic/persistent pain. 
 
Background 
 
Pain becomes chronic when it persists beyond the typical time it would take for tissue to 
heal (usually 3 months), and therefore chronic pain is commonly defined as consistent or 
recurrent pain that lasts for more than three months (Treede et al., 2015).  Chronic pain affects 
approximately 1 in 5 Canadians (Health Canada, 2021; Schopflocher et al., 2011) and is among 
the leading causes of years lived with disability globally (GBD, 2016).  Chronic pain can be 
classified into sub-categories dependent on either location of the pain (e.g., visceral, 
headache/orofacial, musculoskeletal), the etiology of the pain (e.g., cancer, post-surgical, 
neuropathic), or its features (e.g., primary pain) (Treede et al., 2015).   
The biopsychosocial model of pain illustrates that pain is both a sensory and emotional 
experience (Darnall et al., 2017).  Pain has been described as a subjective perception of sensory 
information that can be influenced by genetics, learned experience, psychological state, and 
sociocultural influences (Gatchel et al., 2007).  Many treatment modalities focus on the sensory 
or physical aspects of pain, but there is much less emphasis on treating the emotional experience 
of pain, and pain specific training for health professionals is lacking (Darnall et al., 2017).  
Emerging studies on interdisciplinary interventions that address the physical, emotional, and 
cognitive aspects of pain have reported small to medium positive effects (e.g., Bujak et al., 2019; 
Joypaul et al., 2019).  Interventions employing mindfulness training reported small effect sizes 
for reductions in pain intensity, along with improvements in quality of life, although the quality 
of evidence analyzed was low (Hilton et al., 2017). A meta-analysis on interventions employing 
neurophysiological pain education, which uses cognitive behavioural techniques (CBT) to re-
conceptualize beliefs about pain, reported small to moderate effect sizes for pain reduction in 
patients with chronic lower back pain (Tegner et al., 2018).  Similarly, moderate effect sizes 
were found in studies employing CBT in patients with chronic low back pain (Hoffman et al., 
2007).   
Interventions that focus on pain education, mindfulness training, and CBT do not involve 
physical manipulations, and as such there is an opportunity to provide care remotely or through 
online or mobile-application-(app)-based programming.  A recent meta-analysis reviewed seven 
studies on app-based interventions for chronic pain and found significant (albeit small) 
improvements in pain intensity (Pfeifer et al., 2020).  Other online or mobile app-based 
interventions for chronic pain in elderly and adolescents have reported improvements in pain 
intensity and emotional functioning (Shaygan & Jaberi, 2021) and improvements in awareness of 
pain response (Berman et al., 2009).  
A mobile app informed by the biopsychosocial model of pain that employs a “mind-
body” approach was evaluated for quality of self-management support functions specific to 
chronic pain.  Mind-body medicine considers the interactions between the brain and body and 
considers how emotional, cognitive, and social factors can influence health (e.g., Morone & 
Greco, 2007).   The mind-body app that we explore in the current trial scored the highest of the 
19 apps evaluated in both number of self-management functions addressed within the app and 
scored among the highest in overall app quality as measured by a standardized rating scale 
(Mobile App Rating Scale) (Devan et al., 2019).  To our knowledge, this mobile app has not 
previously been independently evaluated to determine its efficacy in the treatment of chronic 
pain.  The mind-body app encompasses many of the modalities described above, including 

mindfulness training through meditation, CBT through brain training exercises and journaling, 
and pain education through expert interviews and recorded microlessons.  We aimed to 
investigate the efficacy of the mind-body based mobile app in the treatment of chronic pain using 
a randomized control trial that involved 6-weeks of regular app usage compared to a usual care, 
wait-listed control group.     
 
Hypotheses  
i) 
Participants in the intervention group will report a greater reduction in pain intensity 
compared to control participants. 
ii) 
Participants in the intervention group will report improvements in pain 
catastrophizing, pain interference, and quality of life. 
iii) 
Changes in pain intensity will be correlated with frequency of app usage.  
 
Objectives:  
i) 
To investigate the efficacy of a mind-body based mobile app on the experience of 
chronic pain relative to a waitlisted control group. Outcomes include self-reported 
measures of pain intensity, perceptions/thoughts about pain, quality of life, and/or 
functional ability. 
ii) 
To explore whether frequency of app usage is associated with changes in pain 
intensity and interference.   
iii) 
To explore whether changes (if any) in pain intensity and interference persist six 
weeks post-trial completion. 
 
Primary outcome: Pain intensity as measured using the Brief Pain Inventory (BPI).   
 
Secondary outcomes:  
a. The following additional measures will be compared between the intervention and 
control group: 
• Pain intensity as measured by the PROMIS Pain Severity short form measures 
severity over a 7 day time period.  
• Pain interference as measured by the PROMIS Short Form ((PROMIS Health 
Organization and Cooperative Group, 2012); (Kean et al., 2016). 
• Pain interference as measured by items in the BPI (Cleeland & Ryan, 1994). 
• Thoughts about pain as measured by Pain Catastrophizing Scale (PCS) score 
(Sullivan et al., 1995). 
• Quality of life as measured by the short-form (SF)-12 (Ware et al., 1996) 
• Depression, anxiety, and stress as measured by the DASS-21 (Lovibond & 
Lovibond, 1995). 
• Medication use. 
b. The following exploratory analyses will be performed on the intervention group data: 
• Relationship between all outcomes and frequency of app usage in the intervention 
group. 
• 12-week follow-up analysis (6 weeks post trial end) to determine whether changes (if 
any) persist. 
 
 

Methods 
 
Study Design: This is a parallel group randomized control trial.  Participants meeting eligibility 
criteria at pre-trial self-report screening will be invited to participate in the study.  Participants 
who provide informed consent, complete the baseline data collection, and qualify for study 
inclusion will be randomized to either an intervention group (mind-body app usage for 6-weeks) 
or a wait-listed control (usual care).  Randomization will be stratified on gender and pain 
intensity.  
     
Participants 
 
Inclusion: Participants aged 18 to 75 years who have non-malignant chronic or persistent 
pain.  Chronic pain is generally defined as persistent pain that has lasted for more than 3 months 
(Treede et al., 2015).  Our study will include participants that have had ongoing pain for at least 
6 months, and participants must experience pain at least half the days in the last 6 months (Deyo 
et al., 2014).  Pain can include bodily pain or head pain (migraine/headache).  According to the 
classifications described above by Treede et al., (2015), our study includes participants with 
primary chronic pain, head/orofacial pain, visceral pain, post-surgical, and musculoskeletal 
pain.     
 
Exclusions:  The following participants are excluded from participation.  
Self-reported history of any of the following:  
• 
Psychotic illness or manic episode  
• 
Substance use disorder or problematic substance use within 6 months of start date  
• 
Metastasizing cancers  
• 
Cognitive impairment (that could interfere with using the application)  
• 
Previous experience with the mind-body app under study.  
 
Procedures 
 
Participants qualifying for study inclusion will be randomized to either an intervention group 
(mind-body app) or a control group (usual care, wait-listed). Randomization will be stratified on 
pain intensity on average (from Brief Pain Inventory, item that inquires about pain intensity on 
average) and gender.  We decided to include gender rather than sex for data collection and 
randomization.  Few clinical trials in Canada collect data based on gender, and there are 
numerous ways that gender may impact pain experience (Boerner et al., 2018; Welch et al., 
2017).  Randomization method will involve computer-generated block randomization to create 
varying block sizes of 4 and 8.  We will run the trial in cohorts (run in series) with rolling 
recruitment.  First cohort will start the trial October 15th, 2021 (randomized on October 14th, 
2021).  The anticipated start date for the second cohort is January, 2022 (randomized 
immediately before cohort start).  If we meet our targeted sample size with two cohorts, we will 
stop recruitment.  If we do not have a sufficient sample, we will run a third cohort in Spring, 
2022.  Data will not be analyzed until the final cohort has complete the 12-week follow-up.   
 
Intervention: Participants in the intervention group will be provided 6-weeks of free access to a 
mind-body based app. The app includes activities that are evidence-based and informed to treat 

the biopsychosocial model of pain.  The app is self-directed and includes activities in brain 
training (cognitive behavioural therapy), meditation, pain education, and expressive writing 
(journaling). The app also includes links to podcasts that include interviews with scientific 
experts in chronic pain, pain psychologists, and recovery stories. At the start of the trial 
participants will be given a brief (<5 min) introductory video to orient them to the app and 
provide guidelines and tips. Participants will be asked to engage with the app daily or at 
minimum 4 times per week. A weekly frequency log (during weeks 2, 3, 4, 5, and 6) will be sent 
to participants via email (with a link to survey monkey) to record number of times they used the 
app in the previous 7 days.  During the trial, participants are asked to continue with usual care for 
pain treatments (in addition to app usage). 
 
Control: Participants in the control group will be made aware that they are in the control group 
as they await access to the app following completion of the trial.  They are asked to continue 
with their usual care for pain treatments over the 6-week trial. A weekly email will be sent to 
control participants (with a link to survey monkey), to include similar frequency of contact with 
the research team, and to record any changes (if any) in usual care treatments.  
 
Measures 
All participants (control and intervention) will complete baseline questionnaires (detailed below) 
and a follow-up set of questionnaires at 6 weeks (same as baseline, minus the demographics and 
pain history sections). All questionnaires and logs will be completed through 
surveymonkey.com. To link pre- and post-surveys along with frequency logs, participants will be 
given a unique alphanumeric identifier.  We will do an additional follow-up survey at 12 weeks 
in the intervention group.  This survey will be similar to the survey at 6 weeks, but will also 
inquire whether participant continued with app usage.  
 
Measures:  
The questionnaires will include the following:   
1. Demographics:  We will collect data on gender, age, socioeconomic status 
(education, income), residence, relationship status, dependents, employment status.    
2. Pain history: Participants will provide information on their pain condition.  This 
will include location, diagnosis, date of onset, average frequency, changes in 
employment due to pain.  Other details regarding pain are captured in the 
questionnaires that follow.  
3. Brief Pain Inventory Short Form (BPI-SF) - this includes items about location of 
pain, intensity of pain, current treatments, and interference with 
daily activities (Cleeland & Ryan, 1994)  
4. PROMIS Pain Intensity Scale (Adult Short form) - 3 items (PROMIS Health 
Organization and Cooperative Group, 2012).  
5. PROMIS Pain Interference Scale (Adult Short form) - 8 items (PROMIS Health 
Organization and Cooperative Group, 2012).  
6. Pain Catastrophizing Scale (Sullivan et al., 1995).  
8. DASS-21 (Depression, Anxiety, Stress Scale) - 21 items (Lovibond & Lovibond, 
1995). 
9. QoL questionnaire- SF 12 (Ware et al., 1996).  
  

Data analysis 
 
Power analysis: We estimated a moderate effect size of f = 0.3 (Cohen’s d = 0.6).  A meta-
analysis of mobile app-based interventions for the treatment of chronic pain (Pfeifer et al., 2020) 
reported a small effect at Cohen’s d = 0.4, but the content of the apps was highly variable and not 
all included pain education and/or CBT exercises.  Another meta-analysis on psychological 
interventions that included CBT compared to wait-listed controls reported a Cohen’s d = 0.62 
(Hoffman et al., 2007).  Using G-power (Erdfelder et al., 2009) calculation with an estimated 
power of f = 0.3, a sample size of n = 90 would be required to achieve 80% power (at alpha = 
.05).  We aimed to enroll n = 100 participants in total.  
   
Statistical analysis: Data will be analyzed using repeated measures analysis of co-variance 
(ANOVA) with baseline data as a covariate, intervention vs. control as between-group factors, 
and variable of interest (e.g., pain intensity) as the dependent variable for the primary analysis.  It 
is recommended that randomized controlled trials employ ANCOVA rather than paired t-tests or 
repeated measures ANOVA (Egbewale et al., 2014). 
  
 
 

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