Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Migraine

NCT04604977 | Completed

• 1 other identifier: Be-Home-Kids
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Migraine and Migraine without aura at high frequency are disabling conditions also in adolescence age (2% of adolescents report chronic migraine) Common pharmacological treatments are often inadequate. It has been reported that clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patients to become more conscious about their symptoms and able to manage pain without medication. Generally, according to standard clinical practice, young patients (12-17 yrs old) treated by mindfulness practice come to the hospital to practice mindfulness in small groups of patients for 6 weekly 45 minutes sessions. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients missed the possibility to come for the regular practice to the hospital: for this reason the investigators propose a small pilot study to enforce the use of technology for patients so that they can continue to be followed during their therapeutic process. This preliminary study will be conducted on 25 patients They will be trained to practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital. Also a weekly video-session will be performed to evaluate the clinical condition, to practice guided mindfulness sessions and to encourage to use strategies for pain management . This modality will allow patients to continue their therapeutic process and to be followed regularly during the one year after treatment. Follow up sessions are planned every three months: these meetings at the hospital will be face-to-face with every patient to check the clinical condition by the patient's diary. Last follow up one year after treatment.

Conditions

Headaches Chronic

Outcome Measures

Primary Outcomes (1)

• reduction of headache days

  reduction of at least 50 % of headache days during the treatment period

  at 6 months and 12 months follow-up compared with baseline (Headache Daily Diary)

Secondary Outcomes (5)

• reduction of headache days until last follow up

  at 12 months from withdrawal program (assessed by Daily Diary Card)

• disability score

  6 months - 12 months

• catastrophising attitude

  6 months - 12 months

• depression symptoms

  6 months - 12 months

• trait-state anxiety symptoms (STAI X1-X2)

  6 months - 12 months

Study Arms (1)

Mindfulness by Smartphone

OTHER

an approach that is alternative to current practice, particularly as far as reducing face-to-face hospital visits taking advantage of facilities offered by new technologies, besides including innovative and emerging treatment choices, namely a behavioural approach base on mindfulness

Behavioral: Mindfulness

Interventions

Mindfulness BEHAVIORAL

Patients are followed with a standardized program including: education and support for behavioral measures, behavioral sessions, by mindfulness, once per week for 45 minutes for 6 weeks which usually delivered in groups of 4 - 8 patients.

Mindfulness by Smartphone

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• clinical diagnosis of Chronic Migraine or High Frequency Migraine without aura
• written informed consent

You may not qualify if:

• co-existent severe medical or psychiatric illnesses, documented by specific previous diagnoses
• seizures
• use of opioids
• participation to other projects with behavioral approaches in the last

Sponsors & Collaborators

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

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

Milan, Milano, 20133, Italy

Location

MeSH Terms

Conditions

Headache Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 27, 2020
• Study Start: December 15, 2023
• Primary Completion: December 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

IT (1)