Clinical trial NCT03461874: ACT Therapy for HF Migraine
Official title: Feasibility and Effectiveness of Acceptance and Commitment Therapy (ACT) for High Frequency Episodic Migraine Without Aura
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Migraine Without Aura
Keywords: High-Frequency Migraine without aura
ACT
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2018-03-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to compare the effectiveness of a behavioral treatment, the Acceptance and Commitment Therapy, provided as an add-on to the prophylactic treatment (treatment as usual-TaU) against TaU only on the reduction of monthly headaches frequency over 12 months in a sample of patients with high-frequency migraine without aura (i.e. reporting 9-14 days with headache per month in the previous three months).

ACT will be provided in small groups (5-7 patients each) by specifically trained therapists. The ACT consists in 6 weekly sessions, 90 minutes each, and 2 supplementary "booster" sessions, at two and four weeks after the conclusion of the weekly session. The main focus of the six ACT session will be the following: 1) Creative helplessness: the problem of control; 2) Identifying values: introduction to Mindfulness; 3) Actions guided by values: working with thought; 4) Working with Acceptance and Willingness; 5) Committed Actions: self-as-context; 6) Integration: working with obstacles - wrap-up. The booster session starts with a mindfulness exercise, followed by a review of the contents covered across the ACT program.

TaU will consist of education of patients, followed by pharmacological prophylaxis. Prophylaxis is prescribed based on patients' profile, such as previous failures, contraindications and so on by a neurologist with expertise in headache treatments and limited to Topiramate, Propanolol, Amytriptiline or Calcium channel blockers.

The study will be a Phase II Trial; randomized, Open-Label; Multicenter study. Patients will be randomized 1:1 to the two groups: 64 patients (32 per group) will be enrolled to detect an absolute difference of at least 2 migraine days/month in the experimental group (assuming alfa 5%, power 95%, up to 15% loss to follow-up).

Detailed description: Background and significance. Patients with Migraine without Aura at high frequency of attacks (9/14 episode per month) are particularly exposed to the risk of medication overuse and chronification of their headache. The treatment of this category of patients can be difficult and they need a multidisciplinary treatment to learn techniques to manage their pain before than a chronic migraine condition has been induced. In recent years, non-pharmacological treatments have been proposed for treating patient with different forms of migraines and, among them, Mindfulness showed to be comparable to pharmacological prophylaxis.

ACT (Acceptance Commitment Therapy) belongs to the third wave of behavioral approaches used for different pathological conditions; the attention is focused on mental processes and the objective of this intervention is the psychological flexibility by cultivating six different positive psychological capacities; acceptance, defusion, sense of self, mindfulness, values, committed actions.

Reports in literature documented the effectiveness of ACT intervention to improve disability and impact in pain conditions and to develop the resilience of patients suffering from different physical or mental clinical problems. People with low resilience are exposed to have more emotional difficulties in terms of depression and anxiety and stress, in particular when they are suffering from chronic pain conditions such as migraine at high frequency, which has high impact on patients life. It has been demonstrated that specific interventions addressed to promote resilience can be helpful to reduce the impact of the disease and of pain. Studies on the use of mindfulness and ACT in particular in chronic pain conditions and migraine have demonstrated how these practices are helpful to tolerate pain, to contain the use of symptomatic medications and to modulate some specific characteristics of migraine patients personality, e.g. rigidity, low acceptance, low resilience.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years;
2. Diagnosis of High Frequency Episodic Migraine without Aura according to the IHS criteria, i.e. 9-14 days with headache per month in the previous three months.
3. Patients were stable in terms of pharmacological prophylaxis (for those cases in which it has been prescribed) in the preceding three months.

Exclusion Criteria:

1. Overuse of medications as defined by the ICHD, i.e. 15 or more NSAIDs per month, 10 or more triptans per month, 10 or more opioids, 10 or more combined compounds per month in the previous three months
2. Withdrawal intervention during the 18 months preceding the inclusion in the clinical program
3. Known major depression or other psychiatric condition as reported in clinical documentation
4. Known epilepsy and idiopathic intracranial hypertension as reported in clinical documentation
5. Psychotherapy (any approach) in the previous 18 months
6. Previous experience on mindfulness or meditation approaches (lifetime)

Primary outcomes:
measure: Reduction of headaches frequency
timeFrame: 12 months
Secondary outcomes:
measure: Difference in the proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline
timeFrame: 12 months
measure: Medications intake
timeFrame: 3, 6, 12 months
measure: Change in disability scores, assessed with the Migraine Disability Assessment.
timeFrame: 6, 12 months
measure: Change in impact scores, assessed with the 6-item Headache Impact Test.
timeFrame: 6, 12 months
measure: Change in in anxiety and depression scores, assessed with the Hospital Anxiety and Depression Scale.
timeFrame: 6, 12 months
measure: Change in allodynia, assessed with the Allodynia Symptom Checklist.
timeFrame: 6, 12 months
measure: Change in catastrophizing attitude, assessed with the Pain Catastrophizing Scale.
timeFrame: 6, 12 months
measure: Change in acceptance attitude, assessed with the Acceptance & Action Questionnaire, second version.
timeFrame: 6, 12 months
measure: Change in acceptance attitude, assessed with the Chronic Pain Acceptance Questionnaire.
timeFrame: 6, 12 months
measure: Change in mindfulness, assessed with the Mindfulness Attention Awareness Scale.
timeFrame: 6, 12 months
measure: Change in overall work productivity reduction.
timeFrame: 12 months
measure: Risk of CM development
timeFrame: 12, 24 and 36 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico Carlo Besta
name: Licia Grazzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrasik F, Grazzi L, D'Amico D, Sansone E, Leonardi M, Raggi A, Salgado-Garcia F. Mindfulness and headache: A "new" old treatment, with new findings. Cephalalgia. 2016 Oct;36(12):1192-1205. doi: 10.1177/0333102416667023. Epub 2016 Oct 1.
citation: Giannini G, Zanigni S, Grimaldi D, Melotti R, Pierangeli G, Cortelli P, Cevoli S. Cephalalgiaphobia as a feature of high-frequency migraine: a pilot study. J Headache Pain. 2013 Jun 10;14(1):49. doi: 10.1186/1129-2377-14-49.
citation: Grazzi L, Sansone E, Raggi A, D'Amico D, De Giorgio A, Leonardi M, De Torres L, Salgado-Garcia F, Andrasik F. Mindfulness and pharmacological prophylaxis after withdrawal from medication overuse in patients with Chronic Migraine: an effectiveness trial with a one-year follow-up. J Headache Pain. 2017 Dec;18(1):15. doi: 10.1186/s10194-017-0728-z. Epub 2017 Feb 4.
citation: Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J. Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther. 2006 Jan;44(1):1-25. doi: 10.1016/j.brat.2005.06.006.
citation: Luciano JV, Guallar JA, Aguado J, Lopez-Del-Hoyo Y, Olivan B, Magallon R, Alda M, Serrano-Blanco A, Gili M, Garcia-Campayo J. Effectiveness of group acceptance and commitment therapy for fibromyalgia: a 6-month randomized controlled trial (EFFIGACT study). Pain. 2014 Apr;155(4):693-702. doi: 10.1016/j.pain.2013.12.029. Epub 2013 Dec 28.