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MigrainePhase 4BE_BI_MIND_APPNCT05101837

Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions

A Phase 4 study testing Home program in people with Migraine and Neuropathic Pain, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A standardized behavioural approach based on mindfulness delivered mainly by a specific APP on android will be developed and applied for patients with chronic pain conditions, as migraine and neuropathic pain. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraine, Neuropathic Pain
What is being tested?
Home program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
20 Nov 2023to 20 Nov 2023
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of Neuropathic Pain and Chronic Migraine
  • written informed consent

Who cannot join

  • co-existent severe medical or psychiatric illnesses, documented by specific previous diagnoses
  • seizures
  • use of opioids

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Fondazione IRCCS Istituto Neurologico Carlo Besta

    Milan, Italia, 20133

Other trials in Italy

About this study

Official title: Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions to Patients with Different Kinds of Pain Condition: a Pilot Study

A standardized behavioural approach based on mindfulness delivered mainly by a specific APP on android will be developed and applied for patients with chronic pain conditions, as migraine and neuropathic pain.

The aim of this pilot study:

The investigators propose a pilot study to enforce the application of a Home-program for patients with different pain conditions, to learn mindfulness practice, added to a regular mindfulness guided face-to-face program, by using the technology with android to receive mindfulness sessions for daily practice and to assess the feasibility and the effectiveness of behavioural approach base on mindfulness delivered with this modality.

Read the detailed description

Background and significance Different clinical experiences confirmed the effectiveness of interventions based on the application of standardized behavioural approaches to support pharmacological traditional treatments for pain conditions in the last decades. Also, different clinical experiences were performed by using electronic devices to deliver home-sessions of behavioral approach (mindfulness) to patients that can practice regularly and supported by mindfulness recorded sessions

The aspect of feasibility of these treatments is not reported in published studies, but it can be estimated that standardized behavioural therapies are used in helping patients to obtain a better outcome for pain management

In particular, the use of technology to deliver behavioral exercises to patients suffering from different pain conditions, as neuropathic pain and migraine, have been reported in the literature of the last decades. Exercise-based on telemedicine and smartphone applications seem appropriate, as they have been recently tested in the management of chronic pain conditions to reinforce the efficacy of pharmacological therapies and to teach patients to manage their pain and to be more conscious about their clinical condition and about the use of drugs.

Being tested
Home program
Medical subject headings
Migraine Disorders, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home programDevice

    Regular mindfulness guided face-to-face program, by using the technology with android to receive mindfulness sessions for daily practice and to assess the feasibility and the effectiveness of behavioural approach base on mindfulness delivered with this modality

Study groups in NCT05101837
Study groupRoleWhat they receive
MIND-GROUPExperimentalDaily mindfulness sessions on android
Receives: Device: Home program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence at the program

    To test the adherence of patients at the program. This evaluation will be conducted at the end of the program (Morisky, 2008)

    Measured: 2 months

Secondary outcomes (4)

  1. Monthly headache days or days with pain and medication intake

    Changes in monthly headache days or days with pain and medication intake compared with baseline, by daily diary card to record pain level on a Visual Analogue Scale (VAS) from 0 as no pain to 10 as Maximum pain; also medication intake reporded on the daily diary card.

    Measured: at 2 months

  2. Self-efficacy

    Changes in self-efficacy (by GSE score) (Generalized Self-Efficacy Scale) at 2months from the beginning of the program compared to baseline (minimum score 10-low level of self- efficacy=worse outcome; maximum score 40-high level of self-efficacy=better outcome ) (Scholz, 2002)

    Measured: at 2 months

  3. FIVE FACET MINDFULNESS

    Changes in FFMQ questionnaire FIVE FACET MINDFULNESS QUESTIONNAIRE compared to baseline (Baer, 2006): this questionnaire measures the mindfulness ability of patients before and after the APP application.

    (minimum score 113.7-low mindfulness ability=worse outcome ; maximum score 144.3-high mindfulness ability=better outcome)

    Measured: at 2 months

  4. System Usability Scale

    Changes in SUS scale (System Usability Scale) at the end of the program (Brooke, 1996): this scale measures the usability of the APP.

    (minimum score 0-low usability of the APP=worse outcome; maximum score 100-high usability of the APP=better outcome)

    Measured: up to 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2021
  2. Study start20 Nov 2023
  3. Primary completion20 Nov 2023
  4. Study completion20 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
independent interventional non pharmacological pilot study with APP for mindfulness practice on android
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05101837
Sponsor's protocol ID
BE_BI_MIND_APP
Acronym
BE_BI_MIND_APP
Status last verified
Jan 2025
First submitted
27 Sep 2021
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Adamse C, Dekker-Van Weering MG, van Etten-Jamaludin FS, Stuiver MM. The effectiveness of exercise-based telemedicine on pain, physical activity and quality of life in the treatment of chronic pain: A systematic review. J Telemed Telecare. 2018 Sep;24(8):511-526. doi: 10.1177/1357633X17716576. Epub 2017 Jul 11.

    PubMed 28696152

  • Alexander JC, Joshi GP. Smartphone applications for chronic pain management: a critical appraisal. J Pain Res. 2016 Sep 26;9:731-734. doi: 10.2147/JPR.S119966. eCollection 2016. No abstract available.

    PubMed 27713649

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PubMed 16443717

  • Friedman DI, Rajan B, Seidmann A. A randomized trial of telemedicine for migraine management. Cephalalgia. 2019 Oct;39(12):1577-1585. doi: 10.1177/0333102419868250. Epub 2019 Aug 26.

    PubMed 31450969

  • Rizzoli PB, Grazzi L. Adaptation of the management of chronic migraine patients with medication overuse to the suspension of treatment protocols during the COVID-19 pandemic: Lessons from a tertiary headache center in Milan-6-month results. Headache. 2021 Jun;61(6):961-962. doi: 10.1111/head.14140. Epub 2021 Jun 21. No abstract available.

    PubMed 34153116

  • Linardon J. Can Acceptance, Mindfulness, and Self-Compassion Be Learned by Smartphone Apps? A Systematic and Meta-Analytic Review of Randomized Controlled Trials. Behav Ther. 2020 Jul;51(4):646-658. doi: 10.1016/j.beth.2019.10.002. Epub 2019 Nov 26.

    PubMed 32586436

  • Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

    PubMed 18453793

  • Qubty W, Patniyot I, Gelfand A. Telemedicine in a pediatric headache clinic: A prospective survey. Neurology. 2018 May 8;90(19):e1702-e1705. doi: 10.1212/WNL.0000000000005482. Epub 2018 Apr 6.

    PubMed 29626180

  • Rosser BA, Eccleston C. Smartphone applications for pain management. J Telemed Telecare. 2011;17(6):308-12. doi: 10.1258/jtt.2011.101102. Epub 2011 Aug 15.

    PubMed 21844177

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Home program in people with Migraine and Neuropathic Pain, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence at the program (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05101837, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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