Internet-Delivered CBT for Migraine
(I-SPY-RCT Trial)
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.12345Why 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.23678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: CBT for Insomnia or Sleep Education
Participants receive internet-delivered CBT for insomnia or sleep education control
Phase 2: CBT for Pain
All participants receive internet-delivered CBT for pain management
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
University of Virginia
Collaborator
Citations
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 ...
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. ...
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.
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 ...
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 ...
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.13777Digital 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 = ...
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.
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