Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Migraine (Be-Home-Kids)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04604977
Recruitment Status : Recruiting
First Posted : October 27, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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.

Condition or disease Intervention/treatment Phase
Headaches Chronic Behavioral: Mindfulness Not Applicable

Detailed Description:

Background and significance Chronic Migraine is not so unusual in pediatric and adolescent age and is about 2% of population in adolescent age. The literature of the last decades confirmed the need to taking care of these patients susceptible to develop medication overuse. There are different pharmacological treatments for migraine in young patients but no one of them has specific indication for this category of patients and their efficacy reaches 30/40% leaving many side effects difficult to manage at this age. The feasibility and the effectiveness of behavioral approaches has been already documented in clinical experiences of the last decades: these approaches revealed efficacy in long-term studies and with control groups and they are totally free of unpleasant effects. Mindfulness practice is one of the most recent behavioral approaches that combined with Acceptance Commitment Therapy offer a suitable and adequate treatment for adolescent patients. These approaches make patients more conscious about their problem and able to learn techniques alternative to medications for managing pain.. Mindfulness and other behavioral therapies have done significant results in terms of clinical improvement for these patients and they are well accepted with a high adherence level. This preliminary study will be performed considering that the Covid-19 emergency reduced significantly the possibility for patients to follow sessions at the hospital and to move among the different Italian regions and the investigators organized a program with education and support by mindfulness , delivered by video sessions. According to the protocols at the Headache Center of the Besta Institute in Milan Italy, patients of this category 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. This approach may be particularly useful in helping patients to obtain a better outcome. All the above discussed considerations are even more relevant in this emergency situation due to the Corona-virus pandemic phenomenon in Italy, with its consequences on mobility of patients and clinical practice. In order to promote different modalities to respond to the needs of patients suffering from this disabling condition during the emergency, exercise-based telemedicine and smartphone applications seem very appropriate, as they have been recently tested in the management of chronic pain conditions. This preliminary study will be performed considering that the Covid-19 emergency reduced significantly the mobility of patients, particularly those living in other Italian regions than Lombardy, and in view of providing an effective and somewhat innovative treatment program for this class of patients. The proposed treatment intervention is based on investigators' experience, and on published reports, but it specifically includes a home based program, visits performed as Video calls, and educational and support strategies aimed to develop skills to reduce clinical symptoms and to cope with pain by a standardized behavioural approach based on mindfulness -

which will be delivered mainly by telemedicine and smartphone applications . The aim of this pilot study is to assess the feasibility and the effectiveness at long-term on relevant outcomes of a specific protocol, designed to be appropriate during the emergency situation due to COVID-19 epidemic, by 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Effectiveness of Home-behavioral Program for Adolescents With Chronic Migraine and High Frequency Migraine Without Aura After the Covid-19 Emergency
Actual Study Start Date : September 15, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Mindfulness by Smartphone
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
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.




Primary Outcome Measures :
  1. reduction of headache days [ Time Frame: at 6 months and 12 months follow-up compared with baseline (Headache Daily Diary) ]
    reduction of at least 50 % of headache days during the treatment period


Secondary Outcome Measures :
  1. reduction of headache days until last follow up [ Time Frame: at 12 months from withdrawal program (assessed by Daily Diary Card) ]
    reduction of at least 50 % of headache days until the last follow up (assessed by Daily Diary Card)

  2. disability score [ Time Frame: 6 months - 12 months ]
    decrease in disability score (Ped MIDAS) - (score of PedMIDAS: 0-10 little disability; 11-30 mild disability; 31-50 moderate disability; more than 50 severe disability)

  3. catastrophising attitude [ Time Frame: 6 months - 12 months ]
    decrease in catastrophising attitude (PCS) - Score more than 30 : clinically relevant level of catastrophising

  4. depression symptoms [ Time Frame: 6 months - 12 months ]
    decrease in depression symptoms (Kovacs) - score =15 mild depression; 15-20 moderate depression; more than 25 severe depression);

  5. trait-state anxiety symptoms (STAI X1-X2) [ Time Frame: 6 months - 12 months ]
    decrease in trait-state anxiety symptoms (STAI X1-X2) - score more than 40 anxiety symptoms abnormal



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04604977


Locations
Layout table for location information
Italy
Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit Recruiting
Milano, Italy, 20133
Contact: Licia Grazzi, MD    +39022394 ext 2366    licia.grazzi@istituto-besta.it   
Contact: Renato Mantegazza, MD    +39022394 ext 2321    crc@istituto-besta.it   
Principal Investigator: Licia Grazzi, MD         
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Layout table for additonal information
Responsible Party: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT04604977    
Other Study ID Numbers: Be-Home-Kids
First Posted: October 27, 2020    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Headache
Pain
Neurologic Manifestations