Mindfulness for Adolescents for CM and HFEM

NCT04968093 | Completed

• 1 other identifier: MINDKIDS
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Migraine (CM) and High Frequency Episodic Migraine (HFEM) without Aura affect adolescents' lives in terms of reduced health, reduced ability to perform daily chores and reduced quality of life. The use of pharmacological prophylaxis in these patients warrants caution, whereas the use of behavioral treatments is gaining support in literature. The main aim of MINDKIDS trial is to test the effect of a seven weekly group sessions of guided mindfulness-based meditation program on 12-month headache frequency reduction, medications intake, disability, anxiety, depression, catastrophizing, and caregivers' burden. This is a single-arm study. All patients will participate to seven weekly guided sessions (60 minutes each) of guided mindfulness meditation, which is aimed to teach and make direct practice with skills intended to enhance sustained, non-judgmental present moment awareness. The intervention's main topics are: posture education; breath use and control; guided body scan; work with sounds; tension release; guided imagery; decentralization of thoughts. Each session is conducted by a neurologist and a psychologist expert in mindfulness practice. During the sessions, patients are asked to close their eyes and focus their attention on the breathing so that they can concentrate on the present moment and on all the sensations. Patients were educated to promote a healthy lifestyle: regular physical activity, avoiding skipping meals, hydration, maintain a regular sleep/wake pattern at least 7-8 hours per night.

Conditions

Migraine in Children; Migraine With Aura

Keywords

Chronic Migraine;; High Frequency Episodic Migraine without Aura;; Mindfulness;; Adolescents

Outcome Measures

Primary Outcomes (1)

• Change in headaches frequency as assessed by specific headache diaries in which patient report headaches' presence in each day

  6 and 12 months

Secondary Outcomes (7)

• Proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline.

  12 months

• Change in the number of medications for acute headaches treatment, included in specific headache diaries in which patients indicate the amount of medications consumed to treat headaches

  6 and 12 months

• Change in disability scores, assessed with the Pediatric Migraine Disability Assessment (PedMIDAS).

  6 and 12 months

• Change in anxiety score, assessed with the Spielberger State-Trait Anxiety Inventory for Children (STAI-CH).

  6 and 12 months

• Change in depression score, assessed with the Kovacs's Children's Depression Inventory (CDI).

  6 and 12 months

Study Arms (1)

Group sessions of mindfulness-based therapy

OTHER

Education of patients followed by seven group sessions of mindfulness-based therapy

Behavioral: Mindfulness-based therapy.

Interventions

Mindfulness-based therapy. BEHAVIORAL

Educational. Patients are given recommendations on the approach to the use of drugs for acute treatment of migraine headache and on lifestyle issues. Patients will be encouraged to restrict use of acute medications to headaches and to engage in regular physical activity, avoiding skipping meals, remain well hydrated, maintain a regular sleep. Mindfulness therapy. The intervention is delivered in small groups and consisted of 7 weekly group sessions. It was aimed to teach and make direct practice with skills intended to enhance sustained, non-judgmental present moment awareness. Each session was conducted by a neurologist and a psychologist. To patients were asked to close their eyes and focus their attention on the breathing so that they can concentrate on the present moment and on all the sensations. Intervention's main topics: posture education; breath use and control; guided body scan; work with sounds; tension release; guided imagery; decentralization of thoughts.

Group sessions of mindfulness-based therapy

Eligibility Criteria

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

You may qualify if:

• diagnosis of episodic migraine without aura (code 1.1 of International Classification of Headache Disorders, third version - ICHD-3) at high frequency (HFEM).
• The clinical features are those of code 1.1 of the ICHD-3, with headache lasting 2-72 hours (which is specific to populations aged \<18) and with frequency 8-14 days/month for \>3 months.
• Diagnosis of Chronic Migraine (CM) (code 1.3 of International Classification of Headache Disorders, third version). Core features are the following:
• Headache (migraine-like or tension-type-like1) on 15 days/month for \>3 months
• Headache occurring in a patient who has had at least five attacks fulfilling criteria for Migraine without aura OR for Migraine with aura
• Headache with migraine-like features for at least 8 days/month for \>3 months, i.e. with typical features of migraine with or without aura, or with the headache believed by the patient to be migraine at onset and relieved by a triptan or ergot derivative

You may not qualify if:

• major psychiatric disorders based on clinical history;
• psychotherapy of any approach in the previous 18 months;
• previous experience of mindfulness or meditation approach

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, 20133, Italy

Location

Related Publications (3)

• Hesse T, Holmes LG, Kennedy-Overfelt V, Kerr LM, Giles LL. Mindfulness-Based Intervention for Adolescents with Recurrent Headaches: A Pilot Feasibility Study. Evid Based Complement Alternat Med. 2015;2015:508958. doi: 10.1155/2015/508958. Epub 2015 Dec 22.

  PMID: 26798398 BACKGROUND

• Kemper KJ, Heyer G, Pakalnis A, Binkley PF. What Factors Contribute to Headache-Related Disability in Teens? Pediatr Neurol. 2016 Mar;56:48-54. doi: 10.1016/j.pediatrneurol.2015.10.024. Epub 2015 Dec 24.

  PMID: 26810775 BACKGROUND

• Leonardi M, Raggi A. A narrative review on the burden of migraine: when the burden is the impact on people's life. J Headache Pain. 2019 Apr 25;20(1):41. doi: 10.1186/s10194-019-0993-0.

  PMID: 31023226 BACKGROUND

MeSH Terms

Conditions

Migraine with Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

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

Model Details: To assess the impact of a mindfulness-based group treatment for adolescents with CM and HFEM on headache frequency reduction over 12 months.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 20, 2021
• Study Start: January 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

IT (1)