ACT Therapy for HF Migraine

NCT03461874 | Completed

• 1 other identifier: ACT protocol
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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).

Conditions

Migraine Without Aura

Keywords

High-Frequency Migraine without aura; ACT

Outcome Measures

Primary Outcomes (1)

• Reduction of headaches frequency

  Reduction of headaches frequency in patients treated by Pharmacological therapy only compared to patients treated by Pharmacological treatment + ACT

  12 months

Secondary Outcomes (12)

• Difference in the proportion of patients achieving the reduction of 50% or more of days with headache compared to baseline

  12 months

• Medications intake

  3, 6, 12 months

• Change in disability scores, assessed with the Migraine Disability Assessment.

  6, 12 months

• Change in impact scores, assessed with the 6-item Headache Impact Test.

  6, 12 months

• Change in in anxiety and depression scores, assessed with the Hospital Anxiety and Depression Scale.

  6, 12 months

Study Arms (2)

Treatment as usual

ACTIVE COMPARATOR

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

Behavioral: Education of patients; Drug: Pharmacological prophylaxis

Treatment as usual + ACT

EXPERIMENTAL

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.

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

Interventions

Education of patients BEHAVIORAL

During withdrawal treatment, patients are given recommendations on the approach to the use of drugs for acute treatment of migraine headache and on lifestyle issues. With regard to drugs, patients will be encouraged to restrict use of acute medications to headaches with "severe pain"; i.e., those rated as 8 or greater on a 0-10 (no pain - pain as bad as it could be). In these instances, patients will be instructed to take Eletriptan (40 mg) and/or Almotriptan (12.5 mg) as the first-line treatment, indomethacin (50 mg) as the second line, and will be specifically urged to avoid opioids. With regard to healthy lifestyle issues, patients will be encouraged to engage in moderate physical activity (i.e., 45 minutes twice per week of aerobic exercise), remain well hydrated, consume 3 meals per day, and maintain a regular sleep/wake pattern with at least 7-8 hours of sleep per night.

Treatment as usual; Treatment as usual + ACT

ACT BEHAVIORAL

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. Patients will be trained in small groups (5-7 patients each) and guided by a specifically trained therapist. They will be educated to practice at home according to the instructions given by the therapist during the sessions.

Treatment as usual + ACT

Pharmacological prophylaxis DRUG

Pharmacological prophylaxis will be prescribed based on patients' profile (e.g. previous failures or contraindications), and limited to Topiramate, Propanolol, Amytriptiline or Flunarizine. Doses will depend on patients' features, and the doses herein reported are to be intended as approximate ones: Topiramate at the dose of 50mg/day; Propanolol at the dose of 20mg/day; Amytriptiline at the dose of 10mg/day; Flunarizine at the dose of 5mg/day.

Treatment as usual; Treatment as usual + ACT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years;
• 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.
• Patients were stable in terms of pharmacological prophylaxis (for those cases in which it has been prescribed) in the preceding three months.

You may not qualify if:

• 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
• Known major depression or other psychiatric condition as reported in clinical documentation
• Known epilepsy and idiopathic intracranial hypertension as reported in clinical documentation
• Psychotherapy (any approach) in the previous 18 months
• Previous experience on mindfulness or meditation approaches (lifetime)

Sponsors & Collaborators

• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Fondazione IRCCS Istituto Neurologico C. Besta, Neuroalgology Unit

Milan, Milano, 20133, Italy

Location

Related Publications (5)

• 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.

  PMID: 27694139 BACKGROUND

• 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.

  PMID: 23759110 BACKGROUND

• 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.

  PMID: 28161874 BACKGROUND

• 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.

  PMID: 16300724 BACKGROUND

• 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.

  PMID: 24378880 BACKGROUND

MeSH Terms

Conditions

Migraine without Aura

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Licia Grazzi, MD

  Fondazione IRCCS Istituto Neurologico Carlo Besta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: March 12, 2018
• Study Start: March 15, 2018
• Primary Completion: July 15, 2020
• Study Completion: December 31, 2022
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

IT (1)