Mind-body Mobile Application for Chronic Pain

Overseen By Cynthia J Thomson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of the Fraser Valley

Disqualifiers: Cognitive impairment, Schizophrenia, Bipolar, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a mind-body mobile application that employs techniques like meditation and cognitive behavioral therapy to help manage chronic pain. It targets individuals who have experienced non-cancer-related pain for at least half the time over the past six months. Participants will be randomly assigned to either a group using the app or a group continuing their usual pain management. Those with chronic pain who haven't used similar apps before and don't have certain mental health or medical conditions might be eligible to join. As an unphased trial, this study provides a unique opportunity to explore innovative pain management techniques that could enhance quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems like you can continue your usual care, but it's best to confirm with the trial organizers.

What prior data suggests that this mind-body mobile application is safe for chronic pain management?

Research has shown that mind-body mobile apps, like the one under study, are generally safe. These apps often incorporate techniques such as meditation, cognitive behavioral therapy, and pain education. A review of similar mind-body methods found no reports of harmful effects or safety issues. However, experts highlight potential risks related to privacy and security in mobile health apps. There might also be side effects from the specific therapies used in the app. Overall, while some potential risks exist, studies have not identified major safety concerns with these mind-body methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for chronic pain, which often involve medications like opioids, NSAIDs, or physical therapy, the mind-body mobile application offers a unique approach by integrating expressive writing, meditation, cognitive behavioral therapy, and pain education all in one app. This holistic method empowers users to manage their pain through psychological and educational techniques directly from their smartphones. Researchers are excited about this treatment because it combines convenience with comprehensive mind-body strategies, potentially reducing reliance on medications and offering a more personalized pain management experience.

What evidence suggests that this mind-body mobile application is effective for chronic pain?

Research shows that mind-body mobile apps can help reduce chronic pain. In this trial, participants will use a mind-body mobile application featuring techniques such as cognitive behavioral therapy (a type of talk therapy), meditation, and pain education. A study on a similar app found that users experienced clear improvements in both physical and mental health compared to non-users. Another study confirmed that these apps rely on solid evidence and incorporate several effective psychological methods. Overall, these apps offer a promising, drug-free way to manage chronic pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Cynthia J Thomson, PhD

Principal Investigator

University of the Fraser Valley

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete an online baseline questionnaire to assess eligibility and initial pain levels

1 week

1 visit (virtual)

Treatment

Participants in the intervention group use a mind-body based mobile application for 6 weeks, while control group continues usual care

6 weeks

Weekly questionnaires (virtual)

Post-intervention Assessment

Participants complete online questionnaires to measure pain intensity, interference, and mental health outcomes

1 week

1 visit (virtual)

Follow-up

Participants in the intervention group complete a follow-up questionnaire at 12 weeks to assess long-term effects

6 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Mind-body mobile application

How Is the Trial Designed?

Group I: Mind-body mobile application Experimental Treatment 1 Intervention

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.

Group II: Control Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of the Fraser Valley

Lead Sponsor

Trials

4

Recruited

290+

Published Research Related to This Trial

Psychological health mobile applications are being used for various purposes, including self-management, skills training, and symptom tracking, highlighting their versatility in supporting mental health.

Current evidence suggests that these apps can be effective tools in psychological health practice, but there is a need for careful evaluation of their quality and clinical utility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone apps for psychological health: A brief state of the science review. Bush, NE., Armstrong, CM., Hoyt, TV.[2019]

The RELAXaHEAD app, designed for migraine sufferers, was found to be user-friendly and practical, with 92% of participants expressing willingness to use it again after testing its features, including a headache diary and progressive muscle relaxation (PMR).

Participants reported that the PMR feature helped improve their stress and mood, indicating its potential as a beneficial nonpharmacologic treatment option for managing chronic pain conditions like migraines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Design and Experience Preferences in a Novel Smartphone Application for Migraine Management: A Think Aloud Study of the RELAXaHEAD Application. Minen, MT., Jalloh, A., Ortega, E., et al.[2020]

A study analyzing 110 reports of adverse reactions to herbal dietary supplements in Italy found that 23 serious reactions occurred, with 21 requiring hospitalization, highlighting significant safety concerns regarding these products.

Dermatological and cardiovascular issues were the most common reactions, and 9 out of 10 serious hepatic reactions were reported, indicating that the quality and supervision of these supplements are critical for consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. Ippoliti, I., Menniti-Ippolito, F., Mazzanti, G., et al.[2021]

The study aims to evaluate the effects of the Mindfulness Meditation app (MMA) on heart rate variability (HRV), pain, and mood symptoms in participants with chronic pain and depression or anxiety, with a target of at least 60 participants in each group.

Preliminary results suggest that participants using the MMA are expected to show a significant increase in HRV compared to those not using the app, indicating potential benefits of the app in managing psychological and physical symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a 12-Minute Smartphone-Based Mindful Breathing Task on Heart Rate Variability for Students With Clinically Relevant Chronic Pain, Depression, and Anxiety: Protocol for a Randomized Controlled Trial. Azam, MA., Latman, VV., Katz, J.[2020]

A review of 6 systematic reviews identified only 22 stand-alone mobile health apps that have been evaluated in randomized controlled trials (RCTs), primarily focusing on diabetes, mental health, and obesity.

While 11 out of 23 trials showed meaningful health benefits from these apps, the overall quality of evidence was low due to small sample sizes and high risk of bias, indicating a need for more rigorous studies before these apps can be widely prescribed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescribable mHealth apps identified from an overview of systematic reviews. Byambasuren, O., Sanders, S., Beller, E., et al.[2020]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

Mind-body medicine (MBM) leverages the connection between the brain, mind, body, and behavior to promote health, focusing on techniques like exercise, relaxation, and nutrition, and is well-established in the US healthcare system.

MBM is effective in addressing chronic lifestyle-related diseases by enhancing individual resilience and reducing stress, and it operates on principles similar to the placebo effect, making it a valuable approach for self-healing and self-care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Self-healing in health-care: Using the example of mind-body medicine]. Esch, T.[2020]

A new adverse events (AEs) reporting form specifically designed for Korean folk medicine has been developed, incorporating unique characteristics such as folk medicine properties and patient information.

This reporting form is the first of its kind and aims to improve the tracking and understanding of adverse events related to Korean folk medicine, enhancing safety and efficacy monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of an adverse events reporting form for Korean folk medicine. Park, JH., Choi, SM., Moon, S., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07143396

Evaluation of a Mind-Body Based Approach for Chronic ... The investigators are evaluating the effects of a mind-body mobile application, in combination with a guided movement program, on the experience of chronic ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9176230/

Do pain management apps use evidence-based ... The most common psychological components were grounded in CBT, including psychoeducation, sleep hygiene, behavioral activation, coping skills training, and ...

3. tandfonline.com tandfonline.com/doi/full/10.1080/24740527.2024.2352399

Randomized controlled trial investigating the effectiveness ... A short-term mobile app intervention resulted in significant improvements across physical and mental health outcomes compared to wait-listed usual care.

4. researchgate.net researchgate.net/publication/358296180_Do_Pain_Management_Apps_use_Evidence-Based_Psychological_Components_A_Systematic_Review_of_App_Content_and_Quality

(PDF) Do Pain Management Apps use Evidence-Based ... On average, apps contained 8.10 out of 18 psychological components (SD = 2.77) with a MARS quality rating of 4.02 out of 5 (SD = 0.32). The most common ...

5. purdueglobal.dspacedirect.org purdueglobal.dspacedirect.org/bitstreams/09133a3c-1252-4649-89b1-fa61117838fa/download

mindfulness application for pain and mental health The mindfulness application was designed to provide a non-pharmacological alternative for pain management. Through mindfulness techniques such ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7025360/

Safety concerns with consumer-facing mobile health ... Safety of apps is an emerging public health issue. The available evidence shows that apps pose clinical risks to consumers.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4919256/

Reporting and understanding the safety and adverse effect ... The side effects of mobile psychosocial apps might be due to the privacy and security issues, side effects of a particular therapy that is being delivered or ...

8. mdpi.com mdpi.com/2227-9032/10/6/1027

Systematic Review of Mind–Body Modalities to Manage the ... Mind-body modalities (MBMs) can reduce the long-term adverse health effects ... None of the included studies reported adverse events or safety data. 3.6 ...

9. researchgate.net researchgate.net/publication/377631741_Mind-body_internet_and_mobile-based_interventions_for_depression_and_anxiety_in_adults_with_chronic_physical_conditions_A_systematic_review_of_RCTs

(PDF) Mind-body internet and mobile-based interventions ... PDF | This review summarizes the effectiveness of scalable mind-body internet and mobile-based interventions (IMIs) on depression and ...