Wykes 2007.
| Study characteristics | ||
| Methods | Allocation: randomised. Blinding: single‐blind. Duration: 6 weeks and 26 weeks assessment. Setting: inpatient, UK. | |
| Participants | Diagnosis: schizophrenia (DSM‐IV) N = 40 Age: Mean 18.2 years, range 14‐22 years Sex: M 26, F 14 History: diagnosis of schizophrenia with onset of illness prior to 19 years and duration of illness less than 3 years, cognitive difficulties, cognitive flexibility, difficulties in social functioning (as evidenced by at least one problem on the Social Behaviour schedule), on stable dose and type of medication for the last one month Exclusion criteria: Organic brain disorder e.g. epilepsy, IQ < 65, diagnosis of substance abuse as defined by DSM‐IV, plan to change medication during the trial | |
| Interventions |
1. PI: Cognitive Remediation Therapy Thrice a week 40 hourly sessions of CRT. Participants also continued their previous treatment. N = 21 2. Control: treatment‐as‐usual. N = 19 |
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| Outcomes | Cognitive functioning: WCST, Digit span, Modified Six Elements Test Leaving the study early Unable to use: Global state: Social Behaviour Schedule (SBS), Rosenberg Self‐Esteem Scale (no usable data reported) Mental state: BPRS (no endpoint mean or SD given) Quality of life: QoLS (no usable data reported) |
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| Notes | Funding: most of this project was supported by a grant from the Mental Health Foundation to Prof. Wykes and Prof. S. Frangou. Conflict of interest: Not reported. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | Quote: "Block randomisation was used with CRT and control treatment being assigned randomly to 4 patients each within blocks of 8". Response: The exact method of random sequence generation has not been described in the paper. |
| Allocation concealment (selection bias) | Unclear risk | Details of the methods followed by the researcher in order to maintain allocation concealment were not described in the paper. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Participants were recruited from those in contact with mental health services in south London usually while they were in‐patients." Response: Participants received the experimental interventions and control arm received only treatment‐as‐usual. Partcipants and other members of the treatment team were not blind and there were obvious differences in the psychological interventions versus treatment‐as‐usual, which has a risk of introducing bias. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Symptom and quality of life assessments were assessed by an independent rater who was blind to group allocation. Self‐report assessments (cognition and self‐esteem) and informant ratings (social behaviour) were collected by a research assistant who was not blind to group allocation." Response: The cognitive outcomes, self esteem, social behaviour ratings were assessed by raters who were not blind to the allocation status. The outcome assessors for symptoms and quality of life were blind to the intervention received by the participants as described in the paper. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote" "Analyses were based on an intention to treat, i.e. participants were analysed in the treatment group to which they were randomised irrespective of whether they adhered to their treatment." Reason: Intention‐to‐treat analysis was conducted and a study flow diagram is reported by the authors. |
| Selective reporting (reporting bias) | High risk | Clear outcome scores were not reported for many of the outcome measures. Interaction analysis was done and reported for several variables. |
| Other bias | Unclear risk | None reported. |
BPRS: Brief Psychiatric Rating Scale BMT: Bckward Masking Task CACR: Computer Assisted Cognitive Remediation Programme CBCL: Child Behaviour Checklist CG: Computer Games CGAS: Childrens Global Assessment Scale COWAT: Controlled Oral Word Association Test CPT: Continuous Performance Test CRP: Cognitive Remediation Programme CRT: Cognitive Remediation Therapy DSM‐IV(‐TR): Diagnostic and Statistical Manual of Mental Disorders ‐ 4th edition (‐Text Revision) HoNOSCA: Health of the Nation Outcome Scales for Children and Adolescents ICD‐10: International Statistical Classification of Diseases and Related Health Problems‐10th Revision IQ: Intelligent Quotient ITT: Intention to Treat NOS: Not Otherwise Specified PANSS: Positive and Negative Symptom Scale PE: Psychoeducation PedsQL: Pediatric Quality of Life Scale PI: Psychological Interventions PTP: Psychoeducational Treatment Programme QoLS: Quality of Life Scale RAVLT: Rey Auditory Verbal Learning Test RBANS: Repeatable Battery for Assessment of Neuropsychological States SBS: Social Behaviour Schedule SCCS: Self consistency and congruence scale SIPS: Structured Interview for Prodromal Symptoms SOPS: Scale of Prodromal Symptoms SPAN‐12: Span of Apprehension Task TAU: Treatment As Usual TMT‐B: Trail Making Test B VABS: Vineland Adaptive Behavioural Scales WCST: Wisconson Card Sorting Test WISC‐IV: Wisconson Card Sorting Test, 4th Edition WMS‐III: Wechsler Memory Scales, 3rd edition