Internet-Delivered CBT for Migraine

(I-SPY-RCT Trial)

Overseen By Emily Law, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: Non-English, Sleep disorder, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how internet-delivered cognitive-behavioral therapy (CBT) can assist adolescents with both migraines and insomnia. It aims to determine if CBT can reduce sleep problems and lessen migraine-related disability. The trial consists of two parts: one group receives CBT for insomnia followed by CBT for pain, while another group receives sleep education first, then CBT for pain. Adolescents aged 11-17 who have experienced headaches for at least three months and insomnia symptoms for the past month, and have internet access, may be suitable candidates. As an unphased trial, this study offers adolescents a unique opportunity to potentially improve their sleep and migraine symptoms through innovative therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that online cognitive behavioral therapy (CBT) for insomnia is generally safe. Studies have found that this therapy improves sleep quality and reduces insomnia symptoms. Participants report better sleep habits and less depression, indicating the treatment is well-tolerated.

For online CBT for pain management, research indicates it effectively reduces pain and disability. The therapy also enhances both physical and mental health, suggesting it is safe and manageable for users.

Overall, both treatments have demonstrated safety, with no major side effects reported in the studies. This suggests that participants in these trials can expect a positive experience with these online therapies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores delivering Cognitive Behavioral Therapy (CBT) for insomnia and pain management through the internet, which is a novel and accessible approach for migraine sufferers. Unlike traditional face-to-face CBT sessions, this method allows participants to access therapy from home, making it more convenient and potentially more engaging. This trial could reveal whether coupling CBT for insomnia with CBT for pain significantly improves migraine symptoms, offering a more holistic and integrated treatment option. By addressing both sleep issues and pain, this approach might reduce migraines more effectively than current migraine treatments, which often focus solely on pain relief.

What evidence suggests that this trial's treatments could be effective for adolescents with migraine and insomnia?

Research has shown that online cognitive behavioral therapy for insomnia (eCBT-I) can greatly improve sleep problems. Studies have found that it reduces insomnia severity, enhances sleep quality, and increases total sleep time. In this trial, one group of participants will receive internet-delivered CBT for insomnia followed by CBT for pain management. Online CBT for pain management is as effective as face-to-face therapy, reducing headache frequency and aiding in chronic pain management. Another group in this trial will receive internet-delivered sleep education followed by CBT for pain management. Both treatments have demonstrated positive results, making them promising options for addressing insomnia and migraine-related pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Emily Law, PhD

Principal Investigator

Seattle Children's Hospital

Are You a Good Fit for This Trial?

This trial is for adolescents aged 11-17 who have had headaches for at least three months and insomnia symptoms in the past month. They must be able to use the internet, speak English, read at a 5th grade level or higher, and complete surveys on their own. Those with diagnosed sleep disorders like apnea or narcolepsy, serious conditions such as diabetes or cancer can't participate.

Inclusion Criteria

Access to the Internet on any web-enabled device

I am between 11 and 17 years old.

I have had headaches for 3+ months and trouble sleeping for the last month.

Exclusion Criteria

I have been diagnosed with a sleep disorder.

Unable to read at 5th grade level or complete surveys independently

I have a serious long-term health condition like diabetes or arthritis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: CBT for Insomnia or Sleep Education

Participants receive internet-delivered CBT for insomnia or sleep education control

6 weeks

Internet-delivered sessions

Phase 2: CBT for Pain

All participants receive internet-delivered CBT for pain management

6 weeks

Internet-delivered sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at 6-month follow-up

What Are the Treatments Tested in This Trial?

Interventions

• Internet-delivered CBT for Insomnia
• Internet-delivered CBT for Pain Management
• Internet-delivered Sleep Education

Trial Overview The trial tests if online cognitive-behavioral therapy (CBT) can help teens with migraines sleep better and reduce headache pain. It compares CBT for insomnia alone against combined CBT for both insomnia and pain management versus just learning about good sleep habits online.

How Is the Trial Designed?

Group I: CBT for Insomnia + CBT for Pain Experimental Treatment 2 Interventions

Participants will receive access to internet-delivered CBT for insomnia during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

Group II: Sleep Education + CBT for Pain Active Control 2 Interventions

Participants will receive access to internet-delivered sleep education during Phase 1 (6 weeks) of the study followed by internet-delivered CBT for pain management during Phase 2 (6 weeks) of the study.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2590142725000205

Internet-delivered Cognitive Behavioral Therapy for Insomnia confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, latency, and total sleep time, achieving ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26867139/

Internet-Delivered Cognitive Behavioral Therapy to Treat ... Internet-delivered cognitive behavioral therapy resulted in a decrease in the insomnia severity index by 4.3 points (95% CI: -7.1, -1.5; p = 0. ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05244889

Digital CBTI for Comorbid Insomnia in Chronic Migraine | ... The main outcomes are insomnia and migraine days and will be collected at post-treatment, and long-term effects will be assessed at month 6. Official Title.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820897

Internet-Guided Cognitive Behavioral Therapy for Insomnia ... This randomized clinical trial compares internet-based cognitive behavioral therapy for insomnia and an internet-based education control ...

5. iaap-journals.onlinelibrary.wiley.com iaap-journals.onlinelibrary.wiley.com/doi/10.1111/aphw.70047

Effectiveness of internet‐based self‐help cognitive behavioral ... Importantly, our findings demonstrate that internet-based self-help CBT-I effectively reduces insomnia severity, with pre-sleep arousal as a key ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10481224/

Effect of an Internet–Delivered Cognitive Behavioral ... The results revealed a significant improvement in participants' sleep hygiene, reduction in insomnia symptoms, and alleviation of depression symptoms. Lee et al ...

7. headachejournal.onlinelibrary.wiley.com headachejournal.onlinelibrary.wiley.com/doi/10.1111/head.13777

Digital Cognitive Behavioral Therapy for Insomnia in Women ... At posttreatment, 12 individuals of the 35 who had completed the treatment had reverted to episodic migraine (34.3% of the sample; ITT = 12/42 = ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357470/

Digitally delivered cognitive behavioral therapy for ... The DMC will review safety data, such as AEs in relation to ear-EEG reported by telephone calls or written reports via letter or email by the participants.