12.26.2013
by John Gever
Deputy Managing Editor, MedPage Today

Headache frequency was significantly reduced in older children with migraine when cognitive behavioral therapy was added to amitryptyline in a randomized trial, researchers said.

Compared with a combination of medication and headache education, children 10 to 17 receiving the cognitive therapy had an average of 4.7 fewer headache days per month (95% CI 1.7-7.7, P=0.002), according to Scott W. Powers, PhD, of Cincinnati Children’s Hospital Medical Center, and colleagues.

Two-thirds of the children in the cognitive therapy group had at least a 50% reduction in monthly headache days, versus 36% of those assigned to the education program, the researchers reported in the Journal of the American Medical Association.

“These findings support the efficacy of cognitive behavioral therapy in the treatment of chronic migraine in children and adolescents,” Powers and colleagues wrote.

Major findings from the study had also been reported earlier this year at the International Headache Congress.

In an accompanying editorial, Michael Connelly, PhD, of Children’s Mercy Hospital in Kansas City, Mo., agreed but suggested that it may be difficult to translate the results into broader clinical practice.

“Youth seeking care for headaches are unlikely to follow advice to see a therapist no matter the evidence,” he wrote, noting that fewer than half of the patients screened for enrollment in the trial agreed to participate.

Connelly also argued that many if not most primary care clinicians lack the time and/or training to “adequately explain the rationale for cognitive behavioral therapy to families and their children,” and that reimbursement issues and other system-related barriers may put the treatment out of reach for many patients.

He suggested that “creative means of delivering cognitive behavior therapy” — such as telephone- and Internet-based programs — may be necessary to make it widely available.

Design and Results

The 1-year trial involved 135 children diagnosed with chronic migraine according to standard criteria, including at least 15 self-reported headache days per month and a Pediatric Migraine Disability Assessment Score (PedMIDAS) of at least 20. A total of 361 were considered eligible after screening, but 226 declined to participate for varied reasons.

Patients were randomized to receive amitryptyline titrated over 8 weeks to a target daily dose of 1 mg/kg, plus either cognitive therapy or headache education. Both programs involved the same total time with a therapist and were delivered in eight weekly 1-hour sessions followed by two monthly booster sessions, plus additional monthly sessions at 3-, 6-, and 9-month follow-up visits.

Participants and their families were partly blinded, in that they were told that two psychological interventions were being evaluated but not which one would be considered the active treatment and which was the control. This level of blinding was maintained through entire study period.

The cognitive therapy taught pain coping skills and included thermal and electromyographic biofeedback to monitor relaxation responses.

Participants maintained diaries for recording headache occurrence, severity, duration, use of abortive medications, and associated symptoms. With help from parents, participants also completed PedMIDAS evaluations every three months.

The primary and secondary outcome measures were headache days the previous month and PedMIDAS scores, respectively, both assessed at the end of 20 weeks of treatment. These measures were also tracked at the 3-, 6-, 9-, and 12-month marks in the study.

Monthly headache days at baseline averaged 21.3 across both groups and mean PedMIDAS scores were 68.3, with no difference between treatment groups.

At the 20-week evaluation, monthly headache days averaged 9.8 in the cognitive therapy group and 14.5 in the education group. Median headache days at this evaluation were 5 with cognitive therapy versus 12 with education.

Mean PedMIDAS scores fell to 15.5 with cognitive therapy and to 29.6 in the education group, for a mean intergroup difference of 14.1 points (95% CI 3.3-24.9, P=0.01).

Adverse events were generally similar in the two groups, except that 28 in the education group experienced central nervous system events versus 13 in the cognitive therapy group, and respiratory events were seen in eight children assigned to education versus one in the cognitive therapy group (both P=0.02).

Retention in the trial was relatively good, Powers and colleagues indicated. Of the 64 patients randomized to cognitive therapy, 59 were still following the study protocol at 20 weeks and 57 were continuing at 12 months. Five patients in this group had stopped taking amitryptiline prior to completing 20 weeks and were listed as study dropouts, but in fact they continued with the cognitive therapy, the researchers noted. In the education group, 67 of the 71 original participants stayed in the study for the full 12 months.

Limitations

Powers and colleagues acknowledged that the large number of eligible patients who declined participation was a significant issue in the study. The most common reasons given for refusing to participate were the required time commitment and the delay in starting on medication that would have been necessary during the initial evaluation period.

The widespread desire for medication also led to another significant limitation, the researchers said — the use of amitryptyline in both treatment groups. Powers and colleagues said they included it because they were concerned that recruitment would be even more difficult if parents knew that their children might receive a placebo. They noted “the still widely prevalent preference for medication treatment” in pediatric migraine, even though evidence that it works is mostly lacking.

So, because all the patients took the drug, “we do not yet know if cognitive behavioral therapy plus amitryptyline is superior to cognitive behavioral therapy alone,” Powers and colleagues wrote.

Connelly told MedPage Today in an interview that the belief in medication may actually be a obstacle to effective treatment.

“I think that is a barrier in some ways to folks wanting to pursue cognitive behavioral therapies or other psychological interventions for a ‘medical’ condition,” he said.

However, the effectiveness of cognitive therapy in the trial confirms what was already known about migraine and other pain states, he said, which is that they include significant psychological components.

“Migraine in particular … is a stress-sensitive condition,” he noted. “Migraine is amenable to changing how kids perceive pain, how they manage their stress, the type of coping strategies that they have. Those types of strategies are actually changing or transforming the perception of pain in some ways.”

• Reviewed by Zalman S. Agus, MD Emeritus Professor, Perelman School of Medicine at the University of Pennsylvania and Dorothy Caputo, MA, BSN, RN, Nurse Planner

LAST UPDATED 01.24.2014