Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT06795867
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • acceptance and commitment therapy — BEHAVIORAL
    a 'third wave behavioral management

Study Details

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

Key Dates

Start date
Apr 21, 2025
Status verified
Oct 2025
Primary completion
Dec 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ACT plus usual treatment
    the addition of acceptance and commitment therapy to usual treatment
  • No Intervention: Usual treatment alone
    usual treatment without additional intervention

Primary Outcome Measure

Change in Headache Disability Index [ Time Frame: 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's / Faulkner HospitalBostonMassachusetts02130
Odysseas Nikas
617-983-7580

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