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Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine

Does Acceptance and Commitment Therapy (ACT) Improve Disability in Chronic Migraine? A Randomized Headache Center Trial

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits, 8 visits, 1 visit
  • Time periods mentioned: 2 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Four times over the following year, participants will answer questions about their symptoms during each of four virtual visits."
  • "Initial ACT training requires 8 virtual group visits over 2 months."
  • "After the consent process is completed, the participant will be randomized to group A or B and questionnaires will be administered."
  • "A participant will be considered lost to follow-up if he or she fails to return for one scheduled visit and study staff are unable to contact the participant after at least 3 attempts."
  • "Study procedures as per the Schedule of Activities, include questionnaires and the recording of diary information, along with assessment of any adverse events: Data will be maintained in a secure fashion as described elsewhere in the protocol."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (1)

MA