0
Original Investigation |

Cognitive Behavioral Therapy Plus Amitriptyline for Chronic Migraine in Children and Adolescents:  A Randomized Clinical Trial

Scott W. Powers, PhD1,3,4; Susmita M. Kashikar-Zuck, PhD1,4; Janelle R. Allen, MS1,3; Susan L. LeCates, MSN2,3; Shalonda K. Slater, PhD1,3,4; Marium Zafar, PsyD1; Marielle A. Kabbouche, MD2,3,4; Hope L. O’Brien, MD2,3,4; Chad E. Shenk, PhD1,4; Joseph R. Rausch, PhD1,4; Andrew D. Hershey, MD, PhD2,3,4
[+] Author Affiliations
1Division of Behavioral Medicine and Clinical Psychology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio
2Division of Neurology, Cincinnati Children’s Hospital Medical Center
3Headache Center, Cincinnati Children’s Hospital Medical Center
4Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio
JAMA. 2013;310(24):2622-2630. doi:10.1001/jama.2013.282533.
Text Size: A A A
Published online

Importance  Early, safe, effective, and durable evidence-based interventions for children and adolescents with chronic migraine do not exist.

Objective  To determine the benefits of cognitive behavioral therapy (CBT) when combined with amitriptyline vs headache education plus amitriptyline.

Design, Setting, and Participants  A randomized clinical trial of 135 youth (79% female) aged 10 to 17 years diagnosed with chronic migraine (≥15 days with headache/month) and a Pediatric Migraine Disability Assessment Score (PedMIDAS) greater than 20 points were assigned to the CBT plus amitriptyline group (n = 64) or the headache education plus amitriptyline group (n = 71). The study was conducted in the Headache Center at Cincinnati Children’s Hospital between October 2006 and September 2012; 129 completed 20-week follow-up and 124 completed 12-month follow-up.

Interventions  Ten CBT vs 10 headache education sessions involving equivalent time and therapist attention. Each group received 1 mg/kg/d of amitriptyline and a 20-week end point visit. In addition, follow-up visits were conducted at 3, 6, 9, and 12 months.

Main Outcomes and Measures  The primary end point was days with headache and the secondary end point was PedMIDAS (disability score range: 0-240 points; 0-10 for little to none, 11-30 for mild, 31-50 for moderate, >50 for severe); both end points were determined at 20 weeks. Durability was examined over the 12-month follow-up period. Clinical significance was measured by a 50% or greater reduction in days with headache and a disability score in the mild to none range (<20 points).

Results  At baseline, there were a mean (SD) of 21 (5) days with headache per 28 days and the mean (SD) PedMIDAS was 68 (32) points. At the 20-week end point, days with headache were reduced by 11.5 for the CBT plus amitriptyline group vs 6.8 for the headache education plus amitriptyline group (difference, 4.7 [95% CI, 1.7-7.7] days; P = .002). The PedMIDAS decreased by 52.7 points for the CBT group vs 38.6 points for the headache education group (difference, 14.1 [95% CI, 3.3-24.9] points; P = .01). In the CBT group, 66% had a 50% or greater reduction in headache days vs 36% in the headache education group (odds ratio, 3.5 [95% CI, 1.7-7.2]; P < .001). At 12-month follow-up, 86% of the CBT group had a 50% or greater reduction in headache days vs 69% of the headache education group; 88% of the CBT group had a PedMIDAS of less than 20 points vs 76% of the headache education group. Measured treatment credibility and integrity was high for both groups.

Conclusions and Relevance  Among young persons with chronic migraine, the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline. These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents.

Trial Registration  clinicaltrials.gov Identifier: NCT00389038

Figures in this Article

Sign In to Access Full Content

Don't have Access?

Register and get free email Table of Contents alerts, saved searches, PowerPoint downloads, CME quizzes, and more

Subscribe for full-text access to content from 1998 forward and a host of useful features

Activate your current subscription (AMA members and current subscribers)

Purchase Online Access to this article for 24 hours

Figures

Place holder to copy figure label and caption
Figure 1.
Flow of Participants Through the Trial
Graphic Jump Location
Place holder to copy figure label and caption
Figure 2.
Results From Baseline to 12-Month Posttreatment Follow-up for Cognitive Behavioral Therapy Plus Amitriptyline (Treatment Group) and Headache Education Plus Amitriptyline (Control Group)

Error bars indicate 95% confidence intervals. The results of the pretest to posttest analyses appear in Table 3. Post hoc longitudinal analyses from posttest to follow-up were also conducted to examine change in the effect of treatment during this period. These analyses were considered post hoc because we did not have any prior expectations with respect to the pattern of results; thus, these analyses were entirely exploratory. For these analyses, PROC MIXED was used to analyze continuous outcomes with random effects for intercepts and slopes over time, whereas PROC GENMOD with a logistic link function was used to analyze longitudinal change in dichotomous outcomes. The first step in each of these analyses was to test an effect for group differences in linear change across the follow-up period. These results suggest that the treatment effects found from baseline to 20-week posttest were maintained throughout the 12-month follow-up period.

Graphic Jump Location

Tables

References

CME
Meets CME requirements for:
Browse CME for all U.S. States
Accreditation Information
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity. Physicians who complete the CME course and score at least 80% correct on the quiz are eligible for AMA PRA Category 1 CreditTM.
Note: You must get at least of the answers correct to pass this quiz.
You have not filled in all the answers to complete this quiz
The following questions were not answered:
Sorry, you have unsuccessfully completed this CME quiz with a score of
The following questions were not answered correctly:
Commitment to Change (optional):
Indicate what change(s) you will implement in your practice, if any, based on this CME course.
Your quiz results:
The filled radio buttons indicate your responses. The preferred responses are highlighted
For CME Course: A Proposed Model for Initial Assessment and Management of Acute Heart Failure Syndromes
Indicate what changes(s) you will implement in your practice, if any, based on this CME course.
NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Multimedia

Some tools below are only available to our subscribers or users with an online account.

Web of Science® Times Cited: 1

Sign In to Access Full Content

Related Content

Customize your page view by dragging & repositioning the boxes below.

Multimedia Related by Topic

Author Interview

Articles Related By Topic
Related Topics
PubMed Articles
Jobs
brightcove.createExperiences();