Emilsson 2011.
Methods | Randomised controlled trial | |
Participants |
Country: Iceland Setting: ambulatory Age: adults; specific ages not given Sample size: 54 Sex: 34 women, 20 men Inclusion criteria: clinical diagnosis of ADHD; and stable on prescribed ADHD medication for at least a month Exclusion criteria: severe mental illness; active drug abuse; verbal intelligence quotient (IQ) estimated from clinical records to be below 85; and no valid ADHD diagnosis or not prescribed/taking ADHD medication |
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Interventions |
Intervention: CBT (15 sessions total, twice weekly, each lasting 90 minutes) + pharmacotherapy (n = 27) Control: treatment as usual (n = 27) Methylphenidate dosages ranged between 18‐180 mg, with a mean dosage of 60.5 mg at baseline. By the end of treatment, the dosage range was 36‐162 mg, with a mean dosage of 62.5 mg. |
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Outcomes |
Primary outcomes
Secondary outcomes
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Notes | We contacted authors to get the information about random sequence generation and allocation concealment that we included in this table (Young 2014 [pers comm]). Study start date: not specified Study end date: not specified Funding source: Support for the study was received from research grants awarded by RANNIS the Icelandic Centre for Research (Nr. 080443022), the Landspitali Science Fund, and Janssen‐Cilag, Iceland. Declarations of interest: Brynjar Emilsson, Jon F Sigurdsson, Gisli Baldursson, Emil Einarsson and Halldora Olafsdottir declare that they have no competing interests. Susan Young has been a consultant for Janssen‐Cilag, Eli‐Lilly and Shire. She has given educational talks at meetings sponsored by Janssen‐Cilag, Shire, Novatis, Eli‐Lilly and Flynn‐Pharma and has received research grants from Janssen‐Cilag, Eli‐Lilly and Shire. Susan Young is a consultant for the Cognitive Centre of Canada and is co‐author of 'R&R2 for ADHD Youths and Adults'. Gisli Baldursson has been a consultant for Eli‐Lilly and given educational talks at meetings sponsored by Janssen‐Cilag and Shire. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Comment: not described |
Allocation concealment (selection bias) | Unclear risk | Comment: not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: it is not possible to blind personnel in a psychosocial intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The independent evaluators were psychiatrists who were blind to the treatment condition." |
Incomplete outcome data (attrition bias) All outcomes | High risk |
Comment: the proportion of dropouts was 37% in both groups. Quote: "Missing values were not imputed because the ANCOVA calculates outcome whilst adjusting for all baseline data. Between group effect sizes for the outcome assessments were measured using Cohen's d using unadjusted means for the dependent variables and SD pooled for unequal group sizes. Fisher's exact test was used to compare proportions of medication changes. Since this study follows an ITT protocol, statistical analysis of the outcome variables were completed for all participants regardless of medication changes." |
Selective reporting (reporting bias) | Low risk | Comment: the study protocol is not available, but it is clear that the published reports include all expected outcomes, including those that were prespecified. |
Other bias | High risk | Quote: "The participants in both conditions were not asked to refrain from engaging in other interventions during the study period." |
Conflict of interest | Low risk | Comment: no evidence of conflicts of interest |