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

198 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Mind-body mobile application?

Research shows that mobile health apps, including those for mental health, can help with self-management and symptom tracking. Some studies have found that apps delivering cognitive behavioral therapy (a type of talk therapy) can effectively reduce anxiety and depression. ^{1 2 3 4 5}

Is the mind-body mobile application generally safe for humans?

Mind-body medicine, which includes techniques like exercise, relaxation, and stress regulation, is well-established in the US healthcare system and is generally considered safe as it promotes self-healing and self-care. ^{6 7 8 9 10}

How is the Mind-body mobile application treatment different from other treatments for migraines?

The Mind-body mobile application is unique because it offers a non-drug approach to managing migraines through a smartphone app that includes a headache diary and progressive muscle relaxation (PMR), which is a mind-body intervention. This makes it a scalable and accessible option for those seeking nonpharmacologic treatments for chronic pain conditions like migraines. ^{11 12 13 14 15}

What is the purpose of this trial?

This trial is testing a mobile app that uses relaxation and meditation techniques to help people with chronic pain feel better. The app aims to reduce pain by calming the mind. Mindfulness meditation has shown to be effective in reducing pain in people with chronic pain.

Research Team

Cynthia J Thomson, PhD

Principal Investigator

University of the Fraser Valley

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.

Timeline

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)

Treatment Details

Interventions

• Mind-body mobile application

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Smartphone apps for psychological health: A brief state of the science review. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Comparing applets and oranges: barriers to evidence-based practice for app-based psychological interventions. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Prescribable mHealth apps identified from an overview of systematic reviews. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Selecting and describing control conditions in mobile health randomized controlled trials: a proposed typology. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Engagement and Usability of a Cognitive Behavioral Therapy Mobile App Compared With Web-Based Cognitive Behavioral Therapy Among College Students: Randomized Heuristic Trial. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Development of an adverse events reporting form for Korean folk medicine. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Suspected adverse reactions to performance enhancing dietary supplements: Spontaneous reports from the Italian phytovigilance system. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events associated with the use of complementary and alternative medicine in children. [2011]

11. England 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. [2020]

12. Canada 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. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Tension Tamer: delivering meditation with objective heart rate acquisition for adherence monitoring using a smart phone platform. [2022]

14. England pubmed.ncbi.nlm.nih.gov

Brain-In-Hand technology for adults with acquired brain injury: A convergence of mixed methods findings. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

A Review of Smartphone Applications for Persons With Traumatic Brain Injury: What Is Available and What Is the Evidence? [2020]