Granholm 2005.
Methods | Allocation: randomised
Blinding: assessor blind Location: treatment and residential settings, San Diego, America Length of follow‐up: 12 months after the end of treatment |
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Participants | Diagnosis: schizophrenia or schizoaffective disorder (DSM‐IV) N = 76 Sex: 56 M, 20 F Age: mean ˜ 54.5 years, SD ˜ 7 years Included: length of illness: mean ˜ 30.1 years, SD ˜ 11.3 years; age from 42 to 74 years old Excluded: disabling medical problems that would interfere with testing, absence of medical records to inform diagnosis, and diagnosis of dependence on substances other than nicotine or caffeine within the past 6 months |
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Interventions | 1. CBT group*: N = 39 Content: The treatment manual included a participant workbook that contained homework forms. The CBT was developed specifically for patients with schizophrenia; the age‐relevant content modifications were added. To simplify learning and to help participants remember to use cognitive techniques in everyday life, mnemonic aids were provided; behavioural role‐playing exercises and problem‐solving skills. Delivered by: Psychologists or senior graduate students who had 2 years of clinical experience delivered CBT. Frequency: 24 weekly 2‐hour group psychotherapy sessions Treatment duration: 6 months 2. Standard care group: N = 37 Content: Participants continued in whatever ongoing care they were receiving including antipsychotics. Delivered by: not reported Frequency: nor reported Treatment duration: 6 months |
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Outcomes | Mental state: general, positive symptoms, negative symptoms (PANSS scores); depression (HAMD scores), insight (BCSI scores) Functioning: social (UPSA, ILSS scores) Satisfaction with treatment: leaving the study early Unable to use: Knowledge of specific skills and information (The Comprehensive Module Test) (not predefined outcome for this review) Medication dose (not predefined outcome for this review) |
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Notes | *Participants in the CBT group also received the standard care intervention. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "A stratified randomisation procedure was used to assign participants to treatments... sequential list of random numbers." (p.522) Comments: adequate randomisation |
Allocation concealment (selection bias) | Unclear risk | Comments: The author did not state the information about allocation concealment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "...the coordinator was the only staff person other than therapists with knowledge of group membership... The assessors were blind to treatment group." (p. 522) Comments: As the CBT was based on standard care, participants and personnel were not likely to be blinded. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The assessors were blind to treatment group and measures were taken to assure the blinding." (p.522) Comments: The outcome assessor could not foresee assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Comments: Six participants from the CBT group and five participants from the control group left the study early, however, ITT analysis was used to deal with the missing data. |
Selective reporting (reporting bias) | Low risk | Comments: All measured outcomes were reported. |
Other bias | Low risk | Comments: none obvious |