MigraineNCT05003362
ACT for High Frequency Migraine; A Virtual Mindfulness Intervention
A study testing ACT in people with Migraine, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Mindfulness Training specifically for pain to be offered to migraine patients Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Migraine
- What is being tested?
- ACT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2020to 23 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages 18-65
- Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
- 4-14 migraine days per month over the past 3 months
- No change in medication in the past 3 months
- Greater than 1 year of migraines
- Agreeable to participate, commit to all study procedures and to be randomized to either group
- Fluent in English
Who cannot join
- Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol
- Active suicidal ideation
- Moderate to severe depression
- Current alcohol or substance abuse
- Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years
- Current use of narcotics
Show all 10Show fewer
- Psychiatric hospitalization within past year
- Comorbid pain condition rated as more painful than migraine
- Starts new migraine treatment during study
- Inability to complete study visits
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Womens Hospital
Boston, Massachusetts, 02155
About this study
Official title: Acceptance and Commitment Therapy for High Frequency Episodic Migraine
Mindfulness Training specifically for pain to be offered to migraine patients
Read the detailed description
Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.
- Conditions
- Migraine
- Being tested
- ACT
- Keywords
- migraine, high frequency, ACT
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTBehavioural
mindfulness intervention for patients with pain/migraine
| Study group | Role | What they receive |
|---|---|---|
| usual care | No intervention | Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician. |
| ACT | Active comparator | An 8-week mindfulness-based group therapy. Receives: Behavioral: ACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a randomized controlled trial of ACT
Demonstrate that 48 patients can be successfully enrolled and randomized
Measured: one year
Secondary outcomes (12)
Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability
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.
Measured: one year
Change in migraine severity, duration, and medication use.
Severity of each migraine (1-10), duration (hours), and medicines taken assessed by patient-completed migraine logs.
Measured: one year
Change in headache-related disability
Headache Related Disability measured using the validated HIT-6.
Measured: one year
Change in quality of life.
Quality of life assessed using the Migraine Specific Quality of Life Questionnaire (MSQ).
Measured: one year
Change in depression and anxiety.
Depression and anxiety assessed through the Hospital Anxiety and Depression Scale (HADS).
Measured: one year
Change in pain acceptance and pain expectancy.
Pain acceptance assessed through the Chronic Pain Acceptance Questionnaire and pain expectancy during the migraine attacks assessed using the allodynia questionnaire.
Measured: one year
Change in pain catastrophizing.
Pain Catastrophizing Scale (PCS) used to assess distress and rumination experienced due to migraine anticipation.
Measured: one year
Change in distress tolerance.
Distress tolerance will be assessed through the Distress Tolerance Scale.
Measured: one year
Change in physical activity.
Physical activity measured using the Godin Leisure Time Exercise questionnaire.
Measured: one year
Change in perceived stress.
Perceived stress measured through the Perceived Stress Scale (PSS).
Measured: one year
Change in mindfulness.
Mindful Attention and Awareness Scale (MAAS) used to measure receptive awareness and attention to the present.
Measured: one year
Change in cortisol levels.
Salivary Cortisol will be collected to measure the cortisol awakening response.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start25 Oct 2020
- Primary completion23 Nov 2021
- Study completion23 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Responsible party
- Principal investigator, Carolyn A. Bernstein, Brigham and Women's Hospital
- Investigators
- carolyn bernstein, md, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003362
- Sponsor's protocol ID
- 2018P001239
- Status last verified
- Mar 2026
- First submitted
- 20 Jul 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernstein C, Lazaridou A, Paschali M, Vilsmark ES, Rist PM. Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial. J Integr Complement Med. 2024 May;30(5):478-486. doi: 10.1089/jicm.2023.0085. Epub 2023 Nov 27.
PubMed 38011750
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for High Frequency Episodic Migraine
- ClinicalTrials.gov ID
- NCT05003362
- Acronym / sponsor ID
- 2018P001239
- Conditions
- Migraine
- Keywords
- migraine, high frequency, ACT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Institute of Technology
- Study start
- 25 Oct 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 23 Nov 2021 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mindfulness Training specifically for pain to be offered to migraine patients
Detailed description
Patients with high frequency migraine will be randomized to UC or intervention. Those in intervention will attend a multi session training on Acceptance and Commitment Therapy. All participants will track responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- After screening, patients will be randomized and one group will receive the intervention. The investigators will do sequential interventions of the ACT
| Arm | Type | Receives |
|---|---|---|
| usual care | No intervention | –Subjects randomized to the usual care control group will continue using their usual medical care as prescribed by their physician. |
| ACT | Active comparator | Behavioral: ACTAn 8-week mindfulness-based group therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women ages 18-65
- Diagnosis of episodic migraine (according to International Classification for Headache Diagnosis criteria)
- 4-14 migraine days per month over the past 3 months
- No change in medication in the past 3 months
- Greater than 1 year of migraines
Key exclusion criteria (10 listed)
- Any unstable medical or psychiatric conditions requiring immediate treatment or could lead to difficulty complying with the protocol
- Active suicidal ideation
- Moderate to severe depression
- Current alcohol or substance abuse
- Recent Cognitive Behavioral Therapy, Mindfulness Based Cognitive Therapy, Dialectic Behavioral Therapy or Acceptance and Commitment Therapy within past 3 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACTmindfulness intervention for patients with pain/migraine | Behavioural | ACT |
Primary outcome
Feasibility of a randomized controlled trial of ACT
Time frame: one year
Demonstrate that 48 patients can be successfully enrolled and randomized
12 secondary outcomes
Preliminary data on the effectiveness of ACT on migraine frequency and migraine disability
Time frame: one year
Change in migraine severity, duration, and medication use.
Time frame: one year
Change in headache-related disability
Time frame: one year
Change in quality of life.
Time frame: one year
Change in depression and anxiety.
Time frame: one year
Change in pain acceptance and pain expectancy.
Time frame: one year
Change in pain catastrophizing.
Time frame: one year
Change in distress tolerance.
Time frame: one year
Change in physical activity.
Time frame: one year
Change in perceived stress.
Time frame: one year
Change in mindfulness.
Time frame: one year
Change in cortisol levels.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 38011750Bernstein C, Lazaridou A, Paschali M, Vilsmark ES, Rist PM. Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial. J Integr Complement Med. 2024 May;30(5):478-486. doi: 10.1089/jicm.2023.0085. Epub 2023 Nov 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
carolyn bernstein, md principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT in people with Migraine, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a randomized controlled trial of ACT (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05003362, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.