Recruiting

ACT vs. Usual Treatment

Sponsor:

Brigham and Women's Hospital

Code:

NCT06795867

Conditions

Chronic Migraine

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

acceptance and commitment therapy

Study Details

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

Study ID

NCT06795867

Start date

Apr 21, 2025

Status verified date

Oct, 2025

Completion date

Mar, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

acceptance and commitment therapy

a 'third wave behavioral management

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Paul Rizzoli, MD

617 983 7580prizzoli@bwh.harvard.edu

Locations

Brigham and Women's / Faulkner Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

Odysseas Nikas

617-983-7580onikas@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Oct 31, 2025

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-10-31.