Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions (BE_BI_MIND_APP)

January 21, 2025 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Italia
      • Milano, Italia, Italy, 20133
        • Fondazione IRCCS Istituto Neurologico Carlo Besta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIND-GROUP
Daily mindfulness sessions on android
Device: Home program
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence at the program
Time Frame: 2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly headache days or days with pain and medication intake
Time Frame: at 2 months
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.
at 2 months
Self-efficacy
Time Frame: at 2 months
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)
at 2 months
FIVE FACET MINDFULNESS
Time Frame: at 2 months

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)
at 2 months
System Usability Scale
Time Frame: up to 2 months

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)
up to 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Actual)

November 20, 2023

Study Completion (Actual)

November 20, 2023

Study Registration Dates

First Submitted

September 27, 2021

First Submitted That Met QC Criteria

October 21, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 21, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BE_BI_MIND_APP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Migraine

Clinical Trials on Home program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Angola

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe