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

Primary Purpose

Migraine, Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Home program
Sponsored by
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    MIND-GROUP

    Arm Description

    Daily mindfulness sessions on android

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    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.
    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)
    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)
    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)

    Full Information

    First Posted
    September 27, 2021
    Last Updated
    October 21, 2021
    Sponsor
    Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05101837
    Brief Title
    Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions
    Acronym
    BE_BI_MIND_APP
    Official Title
    Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions to Patients With Different Kinds of Pain Condition: a Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    April 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine, Neuropathic Pain

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    independent interventional non pharmacological pilot study with APP for mindfulness practice on android
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MIND-GROUP
    Arm Type
    Experimental
    Arm Description
    Daily mindfulness sessions on android
    Intervention Type
    Device
    Intervention Name(s)
    Home program
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Adherence at the program
    Description
    To test the adherence of patients at the program. This evaluation will be conducted at the end of the program (Morisky, 2008)
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    Monthly headache days or days with pain and medication intake
    Description
    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.
    Time Frame
    at 2 months
    Title
    Self-efficacy
    Description
    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)
    Time Frame
    at 2 months
    Title
    FIVE FACET MINDFULNESS
    Description
    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)
    Time Frame
    at 2 months
    Title
    System Usability Scale
    Description
    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)
    Time Frame
    up to 2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Licia Grazzi, MD
    Phone
    +39022394
    Ext
    2366
    Email
    licia.grazzi@istituto-besta.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Renato Mantegazza, MD
    Phone
    +39022394
    Ext
    2321
    Email
    crc@istituto-besta.it

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    28696152
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    27713649
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    16443717
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31450969
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    34153116
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    32586436
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    18453793
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    29626180
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21844177
    Citation
    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.
    Results Reference
    background

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