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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Acceptance and Commitment Therapy (ACT), a type of behavioral therapy, can improve daily life for people with chronic migraines. Researchers aim to determine if adding ACT to regular migraine treatments can enhance well-being and reduce headache frequency. Participants will be divided into two groups: one will receive ACT classes along with their normal treatment, while the other will continue with just their usual treatment. The trial seeks individuals diagnosed with chronic migraine who receive care at the Graham Headache Center and have access to technology for online participation. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance migraine treatment options.

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 prior data suggests that Acceptance and Commitment Therapy is safe for adults with chronic migraine?

Research has shown that Acceptance and Commitment Therapy (ACT) is generally safe and well-tolerated. In past studies with individuals experiencing migraines, ACT improved quality of life and reduced headache-related issues. These studies reported no major negative effects specifically linked to ACT, suggesting it is a safe option for most people. The therapy helps individuals accept their pain and become more mentally flexible, aiding in the management of chronic conditions like migraines without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acceptance and Commitment Therapy (ACT) for treating chronic migraines because it offers a unique psychological approach, unlike traditional medications that primarily target symptoms. ACT focuses on helping individuals accept their pain and commit to actions that improve their quality of life, potentially reducing the overall impact of migraines. This method is distinct because it doesn't just aim to alleviate pain; it empowers patients with strategies to manage their condition more effectively, potentially leading to long-term improvements in well-being.

What evidence suggests that Acceptance and Commitment Therapy is effective for chronic migraine?

Research has shown that Acceptance and Commitment Therapy (ACT) can help people with chronic migraines. One study found that participants using ACT had 3.3 fewer headache days on average, while those not using ACT experienced more headache days. Another study revealed that 63% of people using ACT experienced less disability from their headaches, compared to only 37% who didn't use ACT. Additionally, ACT improved the quality of life for 65% of users, compared to 35% who did not use it. In this trial, participants will either receive ACT in addition to their usual treatment or continue with their usual treatment alone. These findings suggest that adding ACT to regular treatment can significantly benefit people with chronic migraines. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34115399/

Acceptance and commitment therapy for high frequency ... Headache frequency was reduced by 3.3 days (95% CI: 1.4 to 5.2) among those randomized to ACT + TAU, whereas it increased by 0.7 days (95% CI: - ...

2. jpain.org jpain.org/article/S1526-5900(20)30049-3/fulltext

Acceptance and Commitment Therapy for Primary ... At 3-month follow-up, clinical improvement occurred in headache-related disability (63%) and 65% in quality of life in ACT versus 37% and 35% in ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422002336

Acceptance and commitment therapy for episodic migraine The purpose of this paper is to describe how ACT may integrated into the treatment of migraine and to describe the design of a pilot study of ACT for migraine.

4. journals.lww.com journals.lww.com/iahs/fulltext/2021/08030/effectiveness_of_acceptance_and_commitment_therapy.3.aspx

Effectiveness of Acceptance and Commitment Therapy on... Therefore, the ACT was effective on perfectionism (P < 0.001) and resilience (P < 0.001) of migraine patients. Conclusion: Given the effectiveness of ACT, it is ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03461874

Study Details | NCT03461874 | ACT Therapy for HF Migraine The aim is to compare the effectiveness of a behavioral treatment, the Acceptance and Commitment Therapy, provided as an add-on to the prophylactic ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12455394/

Combination behavioral and pharmacological ... The effects of ACT in treating migraine are primarily based on its ability to enhance psychological flexibility, helping individuals to accept their pain ...

7. trialx.com trialx.com/clinical-trials/listings/325415/acceptance-and-commitment-therapy-to-improve-disability-in-chronic-migraine/

Acceptance and Commitment Therapy to Improve Disability ... Hypothesis: The addition of Acceptance and Commitment Therapy to usual care will improve measures of disability in chronic migraine participants ...

8. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/abs/10.1111/head.14139

Acceptance and commitment therapy for high frequency ... Headache frequency and medication intake decreased in both groups over 12 months, with patients in the TAU + ACT group showing statistically ...