Mindfulness for Adolescents for CM and HFEM
Condition: Migraine in Children; Migraine With Aura
MeSH terms: Migraine Disorders; Migraine without Aura; Migraine with Aura
Study type: Interventional

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%.
    

Intervention name(s): Mindfulness-based therapy.
Intervention type(s): Behavioral
Intervention description(s): 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 model: Single Group Assignment
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.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Migraine;; High Frequency Episodic Migraine without Aura;; Mindfulness;; Adolescents