Velligan 2014.
Methods | Allocation: randomised Blinding: assessor blind Location: public mental health clinics in 2 counties in Texas Length of follow‐up: 15 months |
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Participants | Diagnosis: schizophrenia (DSM‐IV) N = 166* Sex: 37 M, 37 F Age: 18 ‐ 60 years, mean ˜ 39.2 years, SD ˜ 12.5 years Included: fluent English speakers; receiving ongoing treatment with an oral antipsychotic; persisting positive symptoms as evidenced by a score of ≥ 4 on BPRS expanded version, ratings of delusions, hallucinations, and/or suspiciousness; functional impairment as evidenced by a score of < 70 on the social and occupational functioning scale; stable residence; able to understand and complete assessments Excluded: a documented history of significant head trauma, seizure disorder, or mental retardation; a history of substance abuse or dependence in the past month; or a history of violence in the past 6 months (as a safety measure for staff making home visits) |
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Interventions | 1. CBT group*: N = 43 Content: The focus of the sessions was on participant‐identified problems, particularly those that interfered with daily functioning or were distressing, normalising symptoms, and using CBT techniques to develop alternative explanations. Delivered by: masters and doctoral level professionals with > 2 years' experience in assessment and treatment of serious mental illness Frequency: not reported Treatment duration: 9 months 2. Standard care* group: N = 42 Content: consisted of case management and medication follow‐up appointments provided by the local community mental health centre. Medication follow‐up visits occurred approximately every 3 months. Delivered by: not reported Frequency: not reported Treatment duration: 9 months 3. Cognitive Adaptation Training (CAT)**: N = 41 Content: manual‐driven compensatory strategies and environmental supports (signs, checklists, electronic cueing devices) established by a CAT therapist/trainer Delivered by: experienced therapists and non‐experienced therapists Frequency: not reported Treamtent duration: 9 months 4. Cognitive Adaptation Training (CAT) + CBT**: N = 40 Content: CAT and CBT Delivered by: not reported Frequency: not reported Treatment duration: 9 months |
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Outcomes | Satisfaction with treatment: leaving the study early Unable to use: Global state: MCAS ‐ post‐treatment data not reported Mental state: BPRS, AHR, DRS ‐ post‐treatment data not reported |
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Notes | *The term 'Treatment‐as‐usual (TAU)' was used in this paper. Participants in the CBT group also received the standard care intervention. **We did not use data from the Cognitive Adaptation Training (CAT) and MCog (CAT + CBT) groups Study was registered with ClinicalTrials.gov (identifier #NCT01915017). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was stratified by gender and age using a computer generated algorithm created by the study statistician who had no patient contact." (p.2) Comments: Randomisation was well conducted. |
Allocation concealment (selection bias) | Low risk | Quote: "Randomization was stratified by gender and age using a computer generated algorithm created by the study statistician who had no patient contact." (p.2) Comments: Participants and investigators enrolling participants could not foresee assignment. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comments: The author did not address this information. However, participants and personnel were not likely to be blinded because participants in the treatment group received CBT, and the control group only received standard care. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All raters were blind to treatment condition." (p.4) Comments: The outcome assessor could not foresee assignment. |
Incomplete outcome data (attrition bias) All outcomes | High risk | Comments: 19 participants in the treatment group and 15 participants in the control group dropped out from the study. High attrition rate. |
Selective reporting (reporting bias) | High risk | Comments: The post‐treatment data were not reported. |
Other bias | Low risk | Comments: none obvious. This study was funded by National Institute of Mental Health (5R01MH082793). |