Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine

NCT06795867 | Recruiting

• 1 other identifier: 2024P002621
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the behavioral treatment called Acceptance and Commitment Therapy (ACT) works to improve disability in adults with chronic migraine. The main questions it aims to answer are: Does the use of ACT added to usual treatment improve scores on questionnaires designed to measure daily functioning and activity? Does the use of ACT added to usual treatment improve scores on diaries designed to measure headache frequency and pain? Researchers will compare adding ACT to usual headache treatments to usual headache treatments without ACT. Participants who are selected for ACT will take 8 classes to learn ACT and then will practice it at home, in addition to their regular headache treatment. Those not selected will continue their regular headache treatment. Four times over the following year, participants will answer questions about their symptoms during each of four virtual visits. They will also keep a daily headache diary during the study

Conditions

Chronic Migraine

Keywords

migraine; chronic migraine; behavioral management; acceptance and commitment therapy

Outcome Measures

Primary Outcomes (1)

• Change in Headache Disability Index

  Change in Headache Disability Index from baseline to 3 months. Scores at 3 months minus scores at baseline.

  3 months

Secondary Outcomes (6)

• Disability Measures

  Baseline, 3,6 and 12 months

• Anxiety Assessment

  Baseline, 3, 6 and 12 months

• Catastrophizing Score

  Baseline, 3, 6 and 12 months

• Mindfulness Assessment

  Baseline, 3, 6 and 12 months

• Disability Measures

  Baseline, 3,6 and 12 months

Other Outcomes (1)

• Abortive Medication Use

  Through study completion

Study Arms (2)

ACT plus usual treatment

ACTIVE COMPARATOR

the addition of acceptance and commitment therapy to usual treatment

Behavioral: acceptance and commitment therapy

Usual treatment alone

NO INTERVENTION

usual treatment without additional intervention

Interventions

acceptance and commitment therapy BEHAVIORAL

a 'third wave behavioral management

ACT plus usual treatment

Eligibility Criteria

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

You may qualify if:

• Willingness and ability to engage in the consent process
• Willingness to participate in the study, despite randomization outcome
• Availability for the duration of the study
• Diagnosis of chronic migraine followed at the Graham Headache Center
• Access to the necessary resources for participating in a technology-based intervention

You may not qualify if:

• Known major depression or other psychiatric condition
• Non-English speaking
• Secondary headache diagnosis
• Psychotherapy in the prior 18 months
• Any reason the provider feels would limit participant ability to learn or practice ACT
• Any previous experience with mindfulness or meditation approaches

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's / Faulkner Hospital

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Paul Rizzoli, MD

CONTACT

617 983 7580; prizzoli@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief, Headache

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 28, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: October 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)