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
About this trial
This is an interventional other trial for Migraine
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
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
NCT ID
NCT05101837
First Posted
September 27, 2021
Last Updated
October 21, 2021
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
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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Feasibility and Effectiveness of a Specific App to Delivery Mindfulness Sessions
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