ACT for High Frequency Migraine; A Virtual Mindfulness Intervention
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05003362|
Recruitment Status : Recruiting
First Posted : August 12, 2021
Last Update Posted : August 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Migraine||Behavioral: ACT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||randomized control|
|Official Title:||Acceptance and Commitment Therapy for High Frequency Episodic Migraine|
|Actual Study Start Date :||October 25, 2020|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
No Intervention: usual care
Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician.
Active Comparator: ACT
An 8-week mindfulness-based group therapy.
mindfulness intervention for patients with pain/migraine
- Feasibility of a randomized controlled trial of ACT [ Time Frame: one year ]Demonstrate that 48 patients can be successfully enrolled and randomized
- Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability [ Time Frame: one year ]Patient-completed migraine logs will be used to record the number of migraine days/month. Migraine disability will be measured using the validated Migraine Disability Assessment (MIDAS) questionnaire.
- Change in migraine severity, duration, and medication use. [ Time Frame: one year ]Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs.
- Change in headache-related disability [ Time Frame: one year ]Headache Related Disability measured using the validated HIT-6.
- Change in quality of life. [ Time Frame: one year ]Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).
- Change in depression and anxiety. [ Time Frame: one year ]Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).
- Change in pain acceptance and pain expectancy. [ Time Frame: one year ]Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire.
- Change in pain catastrophizing. [ Time Frame: one year ]Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.
- Change in distress tolerance. [ Time Frame: one year ]Distress tolerance will be assessed through the Distress Tolerance Scale.
- Change in physical activity. [ Time Frame: one year ]Physical activity measured using the Godin Leisure Time Exercise questionnaire.
- Change in perceived stress. [ Time Frame: one year ]Perceived stress measured through the Perceived Stress Scale (PSS).
- Change in mindfulness. [ Time Frame: one year ]Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.
- Change in cortisol levels. [ Time Frame: one year ]Salivary Cortisol will be collected to measure the cortisol awakening response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05003362
|Contact: carolyn bernstein, md||617 732 firstname.lastname@example.org|
|United States, Massachusetts|
|Brigham and Womens Hospital||Recruiting|
|Boston, Massachusetts, United States, 02155|
|Contact: carolyn bernstein, md 617-732-9700 email@example.com|
|Principal Investigator: carolyn bernstein, md|
|Principal Investigator:||carolyn bernstein, md||Brigham and Women's Hospital|