Mindfulness for Adolescents for CM and HFEM

NCT ID: NCT04968093

Last Updated: 2021-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2021-01-31

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.

Detailed Description

Background and significance Adolescents with Chronic Migraine (CM) and High Frequency Episodic Migraine (HFEM) without Aura, characterized by 15+ and 9-14 days with headache respectively, pose a relevant burden on adolescents' health, quality of life, as well as on their ability to perform school and leisure time activity. In addition to this, tackling such health conditions in adolescence might be of great importance to reduce the likelihood of a transition to adulthood with CM and medication overuse headache.

In this category of patients, it is suggested to avoid prescribing pharmacological prophylaxis, in favour of non-pharmacological approaches, such as nutraceuticals or behavioural techniques.

Behavioural approaches are considered helpful for younger patients with HFEM and CM to manage pain and to reduce the number of analgesics and the use preventive medications. Mindfulness, in particular, has been applied in several clinical experiences in adults with pain and migraine with encouraging results, with long term benefit similar to that obtained from pharmacological prophylaxis. The clinical use of mindfulness in adolescents is limited to few experiences, however some results in this group of patients are encouraging. A non-randomized pilot study demonstrated acceptability and feasibility of a mindfulness-based treatment for adolescents with recurrent headaches (1). Another study demonstrated how mindfulness was able to reduce depression in children and adolescents suffering from migraine associated with depression (2). A third small pilot study (3) showed positive results with the use of mindfulness in young patients with headache.

Taken as a whole, these studies seem to point out that mindfulness-based protocol for adolescents with CM or HFEM are feasible and acceptable. What has to be better addressed is the effect of such a kind of treatment: available information, however, enable us to hypothesize that reduction in headache frequency from baseline over a 12-months period could be higher or equal to 50%.

Conditions

Migraine in Children; Migraine With Aura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group sessions of mindfulness-based therapy

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

Group Type: OTHER

Mindfulness-based therapy.

Intervention Type: 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.

Interventions

Mindfulness-based therapy.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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

Exclusion Criteria

1. major psychiatric disorders based on clinical history;

2. psychotherapy of any approach in the previous 18 months;

3. previous experience of mindfulness or meditation approach

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

Milan, , Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 26798398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26810775 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31023226 (View on PubMed)

Other Identifiers

MINDKIDS

Identifier Type: -

Identifier Source: org_study_id