Clinical trial NCT04968093: Mindfulness for Adolescents for CM and HFEM
Official title: Effect and Feasibility of a Mindfulness-based Treatment for Adolescents Aged 12-18 With Chronic Migraine and High Frequency Episodic Migraine Without Aura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine in Children
Migraine With Aura
Keywords: Chronic Migraine;
High Frequency Episodic Migraine without Aura;
Mindfulness;
Adolescents
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To assess the impact of a mindfulness-based group treatment for adolescents with CM and HFEM on headache frequency reduction over 12 months.
Primary purpose: TREATMENT

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%.

Eligibility criteria: Inclusion criteria: one of the two main diagnoses are to me met.

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

Primary outcomes:
measure: Change in headaches frequency as assessed by specific headache diaries in which patient report headaches' presence in each day
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline.
timeFrame: 12 months
measure: 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
timeFrame: 6 and 12 months
measure: Change in disability scores, assessed with the Pediatric Migraine Disability Assessment (PedMIDAS).
timeFrame: 6 and 12 months
measure: Change in anxiety score, assessed with the Spielberger State-Trait Anxiety Inventory for Children (STAI-CH).
timeFrame: 6 and 12 months
measure: Change in depression score, assessed with the Kovacs's Children's Depression Inventory (CDI).
timeFrame: 6 and 12 months
measure: Change in catastrophizing scores, assessed with the Pain Catastrophizing Scale (PCS).
timeFrame: 6 and 12 months
measure: Change in caregiver burden score, assessed with the Caregiver Burden Inventory (CBI).
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.