ACT Therapy for HF Migraine (ACTMigraine)

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

Status: Unknown

Conditions: Migraine Without Aura

Treatments: Drug: Pharmacological prophylaxis; Behavioral: ACT; Behavioral: Education of patients

Study type: Interventional

Funder types: Other

Identifiers

NCT03461874

ACT protocol

Details and patient eligibility

About

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).

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Treatment as usual

Active Comparator group

Description:

Education of patients followed by Pharmacological Prophylaxis, prescribed based on patients' profile (e.g. previous failures or contraindications), and limited to Topiramate, Propanolol, Amytriptiline or Calcium channel blockers

Treatment:

Behavioral: Education of patients

Drug: Pharmacological prophylaxis

Treatment as usual + ACT

Experimental group

Description:

Education of patients, Pharmacological Prophylaxis prescribed based on patients' profile, and eight group sessions of 90 minutes of ACT. 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) Indentifying 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.

Treatment:

Behavioral: Education of patients

Drug: Pharmacological prophylaxis

Behavioral: ACT