Acceptance and Commitment Therapy to Improve Disability in Chronic Migraine
ConditionChronic Migraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBrigham and Women's Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Known major depression or other psychiatric condition
Non-English speaking
Secondary headache diagnosis
Psychotherapy in the prior 18 months
Trial design
Design model
Parallel
Treatments tested in this trial
acceptance and commitment therapy
Behaviorala 'third wave behavioral management
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: ACT plus usual treatmentActive comparator 1 intervention
Group B: Usual treatment aloneNo intervention 0 interventions
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
Disability Measures
Headache Disability Index.
Time frame
Baseline, 3,6 and 12 months2
Anxiety Assessment
Hospital Anxiety and Depression Scale
Time frame
Baseline, 3, 6 and 12 months3
Catastrophizing Score
Patient Catastrophizing Scale
Time frame
Baseline, 3, 6 and 12 months4
Mindfulness Assessment
Five Facet Mindfulness Questionnaire
Time frame
Baseline, 3, 6 and 12 monthsOther outcomes
1
Abortive Medication Use
Headache Diary
Time frame
Through study completionSponsors and contacts
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Source ClinicalTrials.gov