Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions

NCT05101837 | Completed Phase 4

• 1 other identifier: BE_BI_MIND_APP
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Migraine; Neuropathic Pain

Outcome Measures

Primary Outcomes (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)

  2 months

Secondary Outcomes (4)

• Monthly headache days or days with pain and medication intake

  at 2 months

• Self-efficacy

  at 2 months

• FIVE FACET MINDFULNESS

  at 2 months

• System Usability Scale

  up to 2 months

Study Arms (1)

MIND-GROUP

EXPERIMENTAL

Daily mindfulness sessions on android

Device: Home program

Interventions

Home program DEVICE

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

MIND-GROUP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead

Study Sites (1)

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Italia, 20133, Italy

Location

Related Publications (9)

• 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.

  PMID: 28696152 BACKGROUND

• 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.

  PMID: 27713649 BACKGROUND

• 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.

  PMID: 16443717 BACKGROUND

• 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.

  PMID: 31450969 BACKGROUND

• 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.

  PMID: 34153116 BACKGROUND

• 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.

  PMID: 32586436 BACKGROUND

• 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.

  PMID: 18453793 BACKGROUND

• 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.

  PMID: 29626180 BACKGROUND

• 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.

  PMID: 21844177 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Neuralgia

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: independent interventional non pharmacological pilot study with APP for mindfulness practice on android

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: November 1, 2021
• Study Start: November 20, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

IT (1)