Powers 2013.
| Study characteristics | ||
| Methods | RCT. 2 arms. Assessed pretreatment, post‐treatment, and 12 months | |
| Participants | End of treatment: n = 124 Start of treatment: n = 135 Sex: 107 F, 28 M Mean age = 14.4 years (SD 2.0) Source = clinic Diagnosis = migraine Mean years of pain = none given |
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| Interventions | "Cognitive behavioral therapy plus amitriptyline" "Headache education plus amitriptyline" |
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| Outcomes | Primary pain outcome: headache frequency Primary disability outcome: Ped‐MIDAS Primary depression outcome: none Primary anxiety outcome: none
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| Notes | COI: "The authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported." Funding: "Funding was provided by grant R01NS05036 from the National Institute of Neurological Disorders and Stroke (Dr Powers), grant 8 UL1 TR000077 from the National Center for Research Resources and the National Center for Advancing Translational Sciences, and grant T32DK063929 from the National Institute of Diabetes and Digestive and Kidney Diseases for some of the postdoctoral fellows who contributed to the trial (Dr Powers, program director). Amitriptyline, which was provided without cost to participants, was purchased using National Institutes of Health grant funds and managed by the investigational pharmacy at Cincinnati Children’s Hospital Medical Center. If prevention drug was clinically prescribed during the 12‐month follow‐up period, families had financial responsibility for the medications as with typical clinical practice." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Block randomization (with varying block sizes of 4‐10) was used, and participants were stratified by age. Randomization was computer generated and supplied via secure e‐mail to the study therapist." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "Randomization was computer generated and supplied via secure e‐mail to the study therapist." Comment: probably done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | "Outcome assessments were conducted by blinded study personnel." Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Attrition was described, however significant differences between completers and non‐completers were not described |
| Selective reporting (reporting bias) | Unclear risk | Data fully reported on request |