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. 2019 Mar 25;2019(3):CD013069. doi: 10.1002/14651858.CD013069.pub2

Koltai 2001.

Methods An RCT comparing effects of a Memory and Coping Program (MCP), in both individual and group formats, vs those of a control condition on measures of cognition and emotional adjustment in people with mild to moderate dementia who had difficulty adjusting to their cognitive losses
Participants 24 participants who were over 60 years old (mean age 73.5) and had received a diagnosis of mild to moderate dementia, according to the Clinical Dementia Rating (CDR) scale. Average years of education for the sample was 15
Interventions Participants in the individual MCP condition (n = 8) attended an average of 6 weekly intervention sessions focused on cognitive and affective functioning. When available, caregivers joined the sessions for the last 10 to 15 minutes
 
 Participants assigned to the group MCP condition (n = 8) attended 5 one‐hour weekly sessions in groups of 2 to 4 persons
 
 Participants in the wait‐list control condition (n = 8) received small‐group MCP after the intervention and assessments had been completed
Outcomes Outcomes included performance on measures of general cognition (including global cognition, memory, language, and construction), mood (depression), subjective memory ability (meta‐memory), and awareness of cognitive deficits
 
 Assessments were conducted before and after the intervention
Country United States of America
Registration status  Study authors provided no information; trial presumed to be unregistered
Conflict of Interests  Not stated
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Randomisation process not described, but interventions were divided (by order of enrolment) into 2 groups of 4
Allocation concealment (selection bias) High risk Study authors did not mention allocation; for this reason, we assumed this was not done
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Study authors did not mention blinding of participants, and the study included a passive control condition (wait‐list), so blinding was not possible
Blinding of outcome assessment (detection bias) 
 All outcomes High risk No blinding; outcomes could have been influenced by lack of blinding
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Two participants from the treatment condition withdrew from the study due to serious illness. No participants withdrew from the control condition. No details were provided regarding the 2 participants who withdrew, and analysis was based only on participants who completed treatment, so it is unclear whether bias may have been due to incomplete data
Selective reporting (reporting bias) High risk Study authors did not report the CERAD memory task, abbreviated "Boston Naming Test," categorical fluency, and Rosen figures of constructional praxis
Other bias Low risk Study appears to be free of other sources of bias