Migraine in ChildrenMINDKIDSNCT04968093
Mindfulness for Adolescents for CM and HFEM
A study testing Mindfulness-based therapy. in people with Migraine in Children and Migraine With Aura, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Migraine in Children, Migraine With Aura
- What is being tested?
- Mindfulness-based therapy.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- major psychiatric disorders based on clinical history;
- psychotherapy of any approach in the previous 18 months;
- previous experience of mindfulness or meditation approach
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
Milan, 20133
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Mindfulness-based therapy.
- Keywords
- Chronic Migraine;, High Frequency Episodic Migraine without Aura;, Mindfulness;, Adolescents
- Medical subject headings
- Migraine with Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based therapy.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Group sessions of mindfulness-based therapy | Other | Education of patients followed by seven group sessions of mindfulness-based therapy Receives: Behavioral: Mindfulness-based therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headaches frequency as assessed by specific headache diaries in which patient report headaches' presence in each day
Measured: 6 and 12 months
Secondary outcomes (7)
Proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline.
Measured: 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
Measured: 6 and 12 months
Change in disability scores, assessed with the Pediatric Migraine Disability Assessment (PedMIDAS).
The PedMIDAS is composed of six items addressing the missed and partially missed school-days, missed and partially missed days for homework activities, missed and partially missed days for leisure activities. The total PedMIDAS score is determined by the sum of items' scores and four severity categories are established: 0-10 no or minimal disability; 11-30 light disability; 31-50 moderate disability; more than 50 high disability
Measured: 6 and 12 months
Change in anxiety score, assessed with the Spielberger State-Trait Anxiety Inventory for Children (STAI-CH).
The STAI-CH is composed by 20 items, rated on a 1-4 scale, which evaluate state anxiety (i.e. temporary feelings at the time of a perceived threat; 0=not at all - 4=very much) and 20 items evaluating trait anxiety (i.e. feelings of stress and worry experienced on a day to day basis; 0=almost never - 4=almost always). The score range is between 20 and 80: higher scores correspond to higher anxiety levels.
Measured: 6 and 12 months
Change in depression score, assessed with the Kovacs's Children's Depression Inventory (CDI).
The CDI consists of 27 items evaluating different symptoms of depression, including mood disturbances, vegetative functions, social behaviour, ability to feel good sensations, self-esteem. The items investigate the influence of depressions in specific contests for young patients. Each item is scored on a 0-2 scale (0=no problem; 1= moderate problem; 2=serious problem) and the total score range is 0-54. A total score higher than 19 indicates risk of depression.
Measured: 6 and 12 months
Change in catastrophizing scores, assessed with the Pain Catastrophizing Scale (PCS).
The PCS addresses the concept of catastrophizing as it relates to pain, i.e. an exaggerated negative mental set brought to bear during actual or anticipated painful experience. It is composed by three subscales each identifying specific dimensions: rumination, which refers to the constant thinking about pain; magnification, which refers to the exaggeration of pain and of its consequences; helplessness, which refers to the belief that there is no or limited possibility that pain may improve. This measure is composed of 13 items, each rated from 0 = "not at all" to 4 = "all the time," yielding total scores ranging from 0 to 52, with higher scores indicating higher tendencies to catastrophize and score values ≥ 30 indicating clinically significant levels of catastrophizing
Measured: 6 and 12 months
Change in caregiver burden score, assessed with the Caregiver Burden Inventory (CBI).
The CBI consists of 24 items evaluated on a 0-4 scale (0=not at all - 4=very much) that describe emotional reactions and difficulties related to the caregiving activity. The items assess issues related to the time required for assistance, the perception of being cut off from other activities and possibilities, fatigue, the reduction of social activities and feelings towards the relative. The total score is linearly transformed on a 0-100 scale: higher scores indicate greater burden.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study startJan 2016
- Primary completionJan 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Migraine in ChildrenStudies of the same condition, open and under way.
- More trials run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968093
- Sponsor's protocol ID
- MINDKIDS
- Acronym
- MINDKIDS
- Status last verified
- Jul 2021
- First submitted
- 13 Jul 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26798398Kemper 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.
PubMed 26810775Leonardi 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.
PubMed 31023226
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04968093
- Acronym / sponsor ID
- MINDKIDS / MINDKIDS
- Conditions
- Migraine in Children, Migraine With Aura
- Keywords
- Chronic Migraine;, High Frequency Episodic Migraine without Aura;, Mindfulness;, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 20 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group sessions of mindfulness-based therapy | Other | Behavioral: Mindfulness-based therapy.Education of patients followed by seven group sessions of mindfulness-based therapy |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- major psychiatric disorders based on clinical history;
- psychotherapy of any approach in the previous 18 months;
- previous experience of mindfulness or meditation approach
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group sessions of mindfulness-based therapy |
Primary outcome
Change in headaches frequency as assessed by specific headache diaries in which patient report headaches' presence in each day
Time frame: 6 and 12 months
7 secondary outcomes
Proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline.
Time frame: 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
Time frame: 6 and 12 months
Change in disability scores, assessed with the Pediatric Migraine Disability Assessment (PedMIDAS).
Time frame: 6 and 12 months
Change in anxiety score, assessed with the Spielberger State-Trait Anxiety Inventory for Children (STAI-CH).
Time frame: 6 and 12 months
Change in depression score, assessed with the Kovacs's Children's Depression Inventory (CDI).
Time frame: 6 and 12 months
Change in catastrophizing scores, assessed with the Pain Catastrophizing Scale (PCS).
Time frame: 6 and 12 months
Change in caregiver burden score, assessed with the Caregiver Burden Inventory (CBI).
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Background: PubMed 26798398Hesse 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.
- Background: PubMed 26810775Kemper 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.
- Background: PubMed 31023226Leonardi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based therapy. in people with Migraine in Children and Migraine With Aura, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headaches frequency as assessed by specific headache diaries in which patient report headaches' presence in each day (time frame: 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04968093, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.