Trautmann 2010.
| Methods | RCT. 3 arms. Assessed at pretreatment, post‐treatment, 6 months | |
| Participants | End of treatment: N = 55; follow‐up N = 40 Start of treatment: N = 68 Sex: 36 F, 30 M Mean age: 12.7 (SD 2.2) Source: newspaper adverts and websites Diagnosis: headache (migraine, tension type headache or combined headache) Mean years of pain: 2.8 (SD 3.0) | |
| Interventions | "Cognitive behavioural therapy, self‐help and management" "Applied relaxation group" "Education" | |
| Outcomes |
Primary pain outcome: clinical reduction in headache frequency
Primary disability outcome: none Primary depression outcome: Children's Depression Inventory Primary anxiety outcome: Pain Catastrophising Scale Primary satisfaction outcome: none Measures reported: Children's Depression Inventory pain diary Children's Depression Inventory Pain Catastrophising Scale health‐related quality of life (KINDL‐R) Strengths and Difficulties Questionnaire |
|
| Notes |
Funding source: German Research Foundation (Number: KR756/16‐2) Declarations of interest: none stated |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "All participants were randomly assigned to one of the three conditions. The randomly ordered list of groups was used to assign sequentially enrolled participants to two intervention groups and the active control condition." Comment: probably done |
| Allocation concealment (selection bias) | Low risk | "The first author randomly selected participants according to a computer‐generated randomisation list by using the 'select cases' random selection option." Comment: probably done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No description found in text Comment: probably not done |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Measures completed at home and mailed back |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition is described. "Furthermore, no significant differences were found between dropouts and completers" |
| Selective reporting (reporting bias) | Low risk | Data were fully reported |
CBT: cognitive behavioural therapy F: female M: male N: number of participants NRS: numerical rating scale JIA: juvenile idiopathic arthritis Ped‐MIDAS: Pediatric Migraine Disability Assessment RAP: recurrent abdominal pain RCT: randomised controlled trial SD: standard deviation TAU: treatment as usual Tx: treatment