Acceptance and Commitment Therapy for Chronic Migraine

Overseen By Paul Rizzoli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Major depression, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 12

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It seems you can continue your usual headache treatment while participating in the study.

What data supports the effectiveness of the treatment Acceptance and Commitment Therapy for chronic migraine?

Research shows that Acceptance and Commitment Therapy (ACT) can improve quality of life, reduce disability, and enhance functioning in people with primary headaches, including migraines. Studies have found that ACT leads to significant improvements in these areas compared to those who did not receive the therapy, with benefits lasting up to a year. ^{1 2 3 4 5}

Is Acceptance and Commitment Therapy (ACT) safe for humans?

Acceptance and Commitment Therapy (ACT) has been studied for various conditions, including chronic pain and headaches, and is generally considered safe for humans. The studies did not report any significant safety concerns, suggesting that ACT is a safe treatment option. ^{1 3 4 5 6}

How does Acceptance and Commitment Therapy differ from other treatments for chronic migraine?

Acceptance and Commitment Therapy (ACT) is unique because it focuses on helping patients accept their pain and commit to living a meaningful life despite it, rather than trying to avoid or eliminate the pain. This approach contrasts with traditional treatments that often emphasize avoiding migraine triggers or solely relying on medication. ^{1 3 4 5 7}

What is the purpose of 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 is for adults with chronic migraines. Participants should be currently experiencing a certain frequency of migraine headaches and willing to attend 8 classes on Acceptance and Commitment Therapy (ACT), in addition to their usual treatment. Details about specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I am willing and able to give my consent to participate.

Access to the necessary resources for participating in a technology-based intervention

Availability for the duration of the study

Exclusion Criteria

I have been diagnosed with major depression or another psychiatric condition.

Non-English speaking

My headache is caused by another health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

ACT Training

Participants receive Acceptance and Commitment Therapy training through 8 virtual group sessions over 2 months

8 weeks

8 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 3, 6, and 12 months

12 months

4 virtual visits

Treatment Details

Interventions

• Acceptance and Commitment Therapy

Trial Overview The study tests if ACT can improve daily functioning and reduce headache frequency when added to regular treatments for chronic migraine sufferers. It compares outcomes between those receiving ACT plus usual care versus those only continuing with their regular care.

Participant Groups

Group I: ACT plus usual treatment Active Control 1 Intervention

the addition of acceptance and commitment therapy to usual treatment

Group II: Usual treatment alone Active Control 1 Intervention

usual treatment without additional intervention

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Acceptance and Commitment Therapy for Primary Headache Sufferers: A Randomized Controlled Trial of Efficacy. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Mechanisms of change in acceptance and commitment therapy for primary headaches. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for high frequency episodic migraine without aura: Findings from a randomized pilot investigation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of a group-based acceptance and commitment additive therapy on rehabilitation of female outpatients with chronic headache: preliminary findings reducing 3 dimensions of headache impact. [2020]

5. England pubmed.ncbi.nlm.nih.gov

One-Day Behavioral Intervention for Distressed Veterans with Migraine: Results of a Multimethod Pilot Study. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Acceptance-Commitment Therapy for Women with Episodic Migraine: A Pilot Randomized Trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

One-Day Acceptance and Commitment Therapy Compared to Support for Depressed Migraine Patients: a Randomized Clinical Trial. [2021]