Puig 2014.
| Study characteristics | ||
| Methods | Allocation: randomised. Blinding: single‐blind. Duration: 3 months. Setting: outpatient, Barcelona, Spain. |
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| Participants | Diagnosis: schizophrenia or schizoaffective disorder with onset at age 17 years or younger (DSM‐IV‐TR)
N = 50 Age: mean for intervention group 16.7 ± 1.6 years, mean for control group 16.8 ± 1.6 years; range 12‐18 years Sex: M 26, F 24 History: a DSM‐IV‐TR schizophrenia or schizoaffective disorder with onset at age 17 years or earlier; being clinically and pharmacologically stabilised, without changes in antipsychotic treatment during the 6 weeks prior to the baseline assessment; and presence of cognitive impairment. At least 1 of the following conditions had to be present: 2 discrepant scores (discrepancy is determined when a T‐score is more than 1 SD below the level of the patient’s IQ), or a normative T‐score of less than 37 on the perseverative errors score of the Wisconsin Card Sorting Test (WCST). Diagnoses and stability of psychopathology were verified by one of the child and adolescent psychiatrists of the research team using DSM‐IV‐TR criteria and based on clinical interviews with patients and their families. Exclusion criteria: current IQ yielding a T‐score of less than 30 (equivalent to an IQ of 70); active substance use disorder; organic brain syndrome or neurological disorder; and having received electroconvulsive therapy in the previous 6 months |
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| Interventions |
1. PI: Cognitive Remediation Therapy Core components of intervention: Strategy learning with progressive complexity, flexibility in thinking, information set maintenance, executive processes, memory control and planning, set/schema formation and manipulation. N = 25. Participants also continued previous treatment (see below). 2. Control:treatment‐as‐usual Psychoeducation about the illness and medical reviews by a psychiatrist, in addition to individual case management by a psychologist and/or social worker. N = 25 |
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| Outcomes | Global State: CGAS Mental state: PANSS Cognitive functioning: Verbal memory: Logical Memory subtests from the Wechsler Memory Scales, 3rd edition (WMS‐III). Total Word Recall and Delayed Recall subtests of the Rey Auditory Verbal Learning Test (RAVLT) Visual memory: Visual Reproduction subtests (WMS‐III) Working memory: Digits and letter number sequencing subtests (WISC‐IV/WAIS‐III) Processing speed: Part A of the Trail Making Test ((TMT) Executive functions: Total errors score on the WCST. Verbal Fluency subtest from the Controlled Oral Word Association Tests (COWAT). Part B of the TMT Global Functioning: Life Skills Profile (LSP), Vineland Adaptive Behavioural Scales (VABS) Leaving the study early |
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| Notes | Funding: Instituto de Salud Carlos III ‐Fondo Investigaciones Sanitarias, European Union ‐ European Regional Development Fund, CIBERSAM, Government of Catalonia Conflict of interest: Dr. Baeza received support from Otsuka for attending a conference. Dr. Bernardo has been a consultant for, received grant/research support and honoraria from, and has been on the speakers/advisory board of Adamed, Almirall, AMGEN, AstraZeneca, Bristol‐Myers Squibb, Eli Lilly and Co., Ferrer, Hersill, Janssen‐Cilag, Lunbeck, Otsuka, Pfizer, Roche, and Servier. Dr. Castro‐Fornieles received support from Eli Lilly and Co. and Shire for attending a conference. Drs. Penades, de la Serna, Sanchez‐Gistau, and Ms. Puig reported no biomedical financial interests or potential conflicts of interest. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Restricted randomisation was conducted using permuted blocks with a fixed size of 8 patients being allocated in 4:4 ratio to receive CRT or TAU according to a computerized allocation sequence." Response: Adequate details of randomisation were mentioned by the authors. |
| Allocation concealment (selection bias) | High risk | Quote: "Although the instructor who administered the CRT (as well as the patients and their relatives) were aware of the allocated intervention, the psychiatrists and neuro‐psychologists who assessed outcomes were blinded to group allocation and unaware of the results from other sources of data." Response: The above quote shows that allocation concealment was not done except for outcome raters. This also has the inadvertent chance of someone coming to know of the allocation of any particular subject. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Although the instructor who administered the CRT (as well as the patients and their relatives) were aware of the allocated intervention, the psychiatrists and neuro‐psychologists who assessed outcomes were blinded to group allocation and unaware of the results from other sources of data." Response: The above quote clearly mentions that participants and many of the personnel involved in the trial were not blind to the allocation status. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "Although the instructor who administered the CRT (as well as the patients and their relatives) were aware of the allocated intervention, the psychiatrists and neuro‐psychologists who assessed outcomes were blinded to group allocation and unaware of the results from other sources of data." Response: With the above design, outcome assessors were blind to the allocation status. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: " A total of 51 patients were randomised to the groups. Of these, 21 dropped out before the post treatment assessment was carried out. The final sample used for analysis included all but one of the randomised participants. One participant was excluded because of change in diagnosis to bipolar disorder with psychotic features during the intervention phase of the study." Response: Outcome data were reported adequately and intention‐to‐treat analysis was conducted. |
| Selective reporting (reporting bias) | Low risk | All outcomes were reported in adequate detail. |
| Other bias | Unclear risk | None reported. |