Cognitive-behavioral therapy (CBT) should be a first-line treatment along with medication for pediatric migraine, and not just an add-on approach when drugs don't work, a new study suggests.
The reduction in headache days per month among children taking amitriptyline and completing a20-week course of CBT was significantly greater than in those treated with amitriptyline and a course of headache education, the study found.
"Our trial demonstrates, for the first time, a clinically meaningful and durable improvement for youth with chronic migraine in a rigorous trial," lead author Scott W. Powers, PhD, co-director, The Headache Center, Cincinnati Children's Hospital, and professor, pediatrics, University of Cincinnati College of Medicine, Ohio, told Medscape Medical News.
"Cognitive-behavioral therapy should be a first-line treatment with preventive medication," he added. "Our job is to advocate for more research, coverage of this therapy by insurance, and education of healthcare providers so that this effective treatment is accessible and available regardless of family circumstances."
The study is published in the December 25 of JAMA.
CBT Package
The trial included children aged 10 to 17 years with chronic headache (15 or more headache days per month) and a Pediatric Migraine Disability Assessment (PedMIDAS) score of greater than 20 points, indicating at least moderate disability. All patients took amitriptyline and were randomly assigned to CBT (treatment group) or headache education sessions (control).
The CBT package included a biofeedback-assisted relaxation component during which participants learned to create a physical state of relaxation through deep breathing, progressive muscle relaxation, and guided imagery. Patients in this group also learned how pain works in the body and how pain can be influenced by behavior, emotions, and thoughts. The package also incorporated other elements as well; for example, the kids learned coping skills, and parents used reinforcement and praise of the child's coping.
The educational group had regular discussions on headache-related topics. All patients received amitriptyline titrated to a goal dose of 1 mg/kg per day at dinner time.
The CBT intervention resulted in a decrease of 11.5 days with headache vs 6.8 days with headache education, a change score difference of 4.7 days (95% confidence interval [CI], 1.7 - 7.7 days; P = .002).
The PedMIDAS decreased by 52.7 points with CBT compared with 38.6 points with education (change score difference, 14.1; 95% CI, 3.3 - 24.9 points; P = .01).
Dr. Scott W. Powers
As well, 66% of the CBT group had a 50% or greater reduction in headache days, a clinically meaningful benchmark, vs 36% of the headache education group (odds ratio, 3.45; 95% CI, 1.66 - 7.15; P < .001).
"The trial demonstrates that cognitive behavioral therapy has a clinically meaningful impact on outcomes, with almost 9 of 10 participants with measured changes in headache days and disability that meet internationally recommended benchmarks for successful interventions — 50% or more reduction in headache days and disability reduced to a little to none level — by the end of follow-up," commented Dr. Powers.
The treatment appeared to be durable. At 1 year, 86% of the CBT patients had a 50% or greater reduction in days of headache vs 69% of the education group, and 88% of the CBT kids had a PedMIDAS of less than 20 points (mild to no disability) vs 76% of the education group.
Staying Power
"So it lasts at least 1 and a half years," commented Dr. Powers. "We know of participants who over 4 years later continue to do well, but we have not yet rigorously tested the long-term impact."
He noted that this study has the longest follow-up for a trial of CBT in pediatric headache that he's aware of. Both treatments were well tolerated, and parents and children in both groups reported high levels of treatment satisfaction and "credibility."
"Kids reported that they like and enjoy CBT," said Dr. Powers. "Even though CBT also helps adults, it's better to learn these skills early in the course of this chronic illness." He added that the study retention rate was over 90% during its 1.5-year course.
CBT has a lot of pluses, he pointed out. Unlike medications, it has the potential to continue to be beneficial after the intervention has ended, said Dr. Powers. Children and adolescents may be more open to an approach that is learning based, and involves active participation and learning new skills, he said. In addition, families may prefer a nonpharmacologic treatment that has few expected adverse effects.
Early intervention is key, Dr. Powers stressed. "Most adults with migraines had them as youth, and youth with migraines are quite likely to continue to have migraines as adults. CBT is now an evidence-based treatment for chronic migraine from ages 10 to 17, and application of this intervention early may have the potential for long-term reduction of pain and disability."
The study did not include a group getting just CBT — without being combined with medication or a placebo — because of a lack of controlled studies of the effectiveness of pharmacologic agents in chronic migraine in youth. So it's still unknown whether CBT plus amitriptyline is superior to CBT alone for the management of chronic pediatric migraine.
Dr. Powers said he hopes the study addresses many questions that surround CBT, including whether it really works, whether improvements are clinically meaningful, whether children and their families will stick with it, whether families find the treatment credible and helpful, and whether the treatment is durable.
"Our trial says 'yes' to all of these questions," said Dr. Powers.
There are perceived barriers to accessing this treatment, including cost, availability, and time, but these can be overcome, he added. CBT can cost less than high-technology tests, such as MRI, but only if it's covered by health insurance at a similar rate. "In terms of actual cost, CBT may be quite cost-effective relative to the costs of many procedures and visits," he noted, and treatments now commonly used in adults.
But the barrier that Dr. Powers sees as the most in need of attention is access. "We need more research on how to make CBT the most accessible and effective it can be," he said. To that end, he and his colleagues are investigating a combination of face-to-face and self-guided learning using the Internet, a phone app, Skype, and telemedicine.
Even though migraines are the eighth leading cause of years lived with disability, and over 200,000 school days are missed in the United States every 2 weeks because of them, this disorder is "under-recognized, underdiagnosed, and underappreciated," noted Dr. Powers.
Research funding and focus on clinical care in kids is "arguably much worse" than it is for adults with chronic migraine, he said.
Unique Study
In an accompanying editorial, Mark Connelly, PhD, a pain psychologist and co-director of the Comprehensive Headache Clinic at Children's Mercy Hospital in Kansas City, Missouri, said the study was "unique" not only because it's the first time that a treatment specifically for pediatric chronic migraine has been studied in a randomized controlled trial but also because the methods were so rigorous.
"Studies of psychological interventions for pediatric pain conditions often are critiqued for small sample sizes, high attrition rates, insufficient duration of follow-up, and suboptimal comparator conditions," Dr. Connelly told Medscape Medical News. However, in this study, "the sample size was adequately large, a very high proportion of children completed both the intervention and control group procedures, changes in the outcome variables continued to be evaluated through 1 year post-treatment, and the comparison condition was thoughtfully selected to control for the therapeutic effect of providing attention and education."
Dr. Connelly agreed there are several "patient, provider, and system barriers," to accessing CBT, including a limited supply of trained CBT providers, limits in insurance coverage, and perceived stigma associated with seeing a mental health provider for a medical condition.
But for Dr. Connelly, the most important barrier might be the "ignorance" of both providers and families. "Most families will not seek out CBT on their own or aren't even aware that this treatment exists, and rely on trusted healthcare providers to make the recommendation."
Although there have been more than 15 trials of CBT techniques in kids with headache — albeit not chronic migraine specifically — many healthcare providers may not be aware of the positive efficacy data, said Dr. Connelly.
The study results suggest that CBT should be a recommended treatment, although the barriers to accessing it need to be considered before it can be widely implemented as a first-line treatment for chronic migraine in children, said Dr. Connelly.
He pointed out that the results of the trial can be applied only to children who seek treatment for chronic migraine, but most families seek treatment for a child only when he or she is failing in school, missing a significant number of classes, or becoming less involved in sports or if other activities are significantly affected.
There are several possible reasons why families don't seek treatment for a child with chronic migraines. Parents may not want their child taking medication, they may assume that headaches are normal for children and don't warrant treatment, or they may be managing the child's migraine with over-the-counter medication at home, a situation that, according to Dr. Connelly, may in some lead to even more frequent headaches.
There are currently no US Food and Drug Administration (FDA)–approved medications for chronic migraine in children and no data from randomized controlled trials on treatments for pediatric chronic migraine. "As such, children with chronic migraine get treated almost solely based on the experience and opinions of the specific provider they see," said Dr. Connelly. Doctor-recommended treatments can range from simple reassurance alone to aggressive medical therapies, such as nerve blocks or intravenous medication, he said.
Funding was provided by the National Institute of Neurological Disorders and Stroke, the National Center for Research Resources and the National Center for Advancing Translational Science, and the National Institute of Diabetes and Digestive and Kidney Diseases. Amitriptyline, which was provided without cost to participants, was purchased using National Institutes of Health grant funds and was managed by the investigational pharmacy at Cincinnati Children's Hospital Medical Center. Dr. Powers and Dr. Connelly have disclosed no relevant financial relationships.
JAMA. 2013;310:2622-2630, 2617-2618.
Medscape Medical News © 2013 WebMD, LLC
Send comments and news tips to news@medscape.net.
Cite this: Cognitive-Behavioral Therapy Effective in Kids' Migraines - Medscape - Dec 24, 2013.
Comments