Gooding 2016

Methods	Design: 3‐arm RCT with parallel‐group design Recruitment period: not reported No. of centres involved: 4 (participants were recruited through the Memory Disorders Center (MDC) at Columbia University, which includes the Alzheimer’s Disease Research Center (ADRC), Doctors Private Offices at the Neurological Institute, and the Memory Disorders Clinic at the New York State Psychiatric Institute (NYSPI), as well as through the Department of Geriatric Psychiatry at the VA Connecticut Healthcare System) Unit of randomisation: individuals No. randomised: 96 (data reported for 74 participants who completed the study ‐ 20 participants in the control group, 31 in the computerised cognitive training group, and 23 in the cognitive vitality programme) Number of arms considered in this review: 3 Maximum trial duration: 4 months Funding by non‐profit organisation: funded by a grant from the Alzheimer’s Association (IIRG‐09–131861) and by a Department of Veterans Affairs RR&D Career Development Award (RRD‐B4146V) Funding by commercial organisation: none stated Publication status: full‐text report
Participants	Patient flow: A total of 96 participants were recruited for this study and completed the baseline neuropsychological evaluation. Of these, 74 participants completed the full treatment, 7 completed partial treatment, and 15 did not complete any portion of the assigned treatment. The overall study attrition rate was 23%. Among those who did not complete treatment, 6 participants dropped out after the baseline neuropsychological evaluation, 4 dropped out after completing a portion of the 2‐month follow‐up evaluation, and 12 dropped out after completing the full 2‐month follow‐up evaluation Data provided only for 74 participants who completed the study: Number of females, n (%): 43 (58.1%) Average age (SD): 75.79 (8.75) Education (years) (mean, SD): 15.14 (2.58) Baseline cognitive function in mMMSE (mean, SD): 50.58 (2.72) Selection criteria: study sample was recruited through the Memory Disorders Center (MDC) at Columbia University and the VA Connecticut Healthcare System. Inclusion criteria: diagnosis of subclinical cognitive decline established by (1) subjective or informant memory complaints; (2) verbal memory impairment, as measured by > 0.5 SD decline on Wechsler Memory Scale‐Revised (WMS‐R) Logical Memory (LM)‐II, or Buschke Selective Reminding Test (BSRT); (3) normal general cognitive function, as determined by Mini Mental State Examination (MMSE) score > 24; and (4) normal independent functioning as determined by physician report and > 75 percentile score on Independent Living Scales (ILS) Ethnicity (%): non‐Hispanic white 59.5%, African American 17.6%, Hispanic/Latino 17.6%, Asian: 5.4% APOE: not reported
Interventions	Type of experimental intervention (2 arms): 1 arm computerised cognitive training (CCT) and 2 arms cognitive vitality training (CVT): treatment phase sessions were provided in individual or group format, twice per week, with each session lasting approximately 60 minutes. Total exposure was the same for all treatment groups and required approximately 30 hours of training within a 16‐week period Details of experimental intervention: CCT: programme incorporated repeated drill‐and‐practice exercises involving memory, attention, and executive functions within domain‐specific training modules that allow for adaptive training with titrated difficulty levels. Software used was BrainFitness version 2.0.1 CVT: participants in the CVT group completed the same exercises as the CCT group using the BrainFitness programme described above, but within an incorporated motivational therapeutic milieu based on the principles put forth by NEAR (allowed to personalise incidental features in the training programme (i.e. can set personal goals rather than follow clinician‐set goals)), provided choice over aspects of the training activity (i.e. can select module of choosing and set personal time constraints), and allowed to conceptualise the training into a meaningful, real‐world situation (i.e. training programme embedded into the context of high‐interest or real‐world themes, such as sport games or simulating a business transaction).This arm was not included in the analysis Type of concomitant treatment provided: not stated Session duration: 60 minutes in experimental group Number of treatment sessions: twice a week for 16‐week period in experimental group Treatment frequency: 2 sessions per week Maximum treatment duration in months: 16 weeks in experimental group Type of control intervention: active; control group, treatment phase sessions were provided in individual or group format, twice per week, with each session lasting approximately 60 minutes. Total exposure was the same for all treatment groups and required approximately 30 hours of training within a 16‐week period Details of control intervention: participants assigned to the ACG worked on various commercially available computer games and puzzles (e.g. BrainAge, Sudoku, crossword puzzles). Participants in this group worked on computerised games in a similar format to individuals in the CCT group (either at the hospital or remotely from home), and treatment dosage and intensity were identical to the CCT group (i.e. total of 2 hours per week) Type of concomitant treatment provided: not stated Session duration: 60 minutes in control group Number of treatment sessions: twice a week for 16‐week period in control group Treatment frequency: 2 sessions per week Maximum treatment duration in months: 16 weeks in control group
Outcomes	Cognitive functioning outcomes considered Global cognitive function with mMMSE on a scale from not reported with higher values indicating benefit Episodic memory with WMS‐R‐II subtest, on a scale from not reported to not reported with higher values indicating benefit Working memory with the Wechsler Adult Intelligence Scale‐Revised Digit Span subtest on a scale from not reported to not reported with higher values indicating benefit (data not reported in the study) Physical functioning outcome considered: none reported Quality of life outcome considered: none reported Safety outcome considered: none reported Depression outcome considered: depression symptoms measured with Beck Depression Inventory 2nd Edition, on a scale from not reported to not reported with lower values indicating benefit Other outcome data on cognitive functioning not considered in our meta‐analyses Episodic memory measured with BSRT verbal learning and memory, WMS‐R LM‐I, WMS‐R Visual reproductions I and II
Notes	Funded by a grant from the Alzheimer’s Association (IIRG‐09–131861) and a Department of Veterans Affairs RR&D Career Development Award (RRD‐B4146V); study authors report no conflict of interest in the study The third arm (CVT) consisted of CCT plus a motivational therapeutic milieu and was not included in the analysis due to the ACG that did not receive the motivational therapeutic milieu intervention
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Judgement: no methods for randomisation described Quote(s): "this randomised clinical trial used a test–re‐test treatment controlled design with recruited patients randomly assigned to one of three research arms ‐ computerised cognitive training (CCT), cognitive vitality training (CVT), or an active control group (ACG)"
Allocation concealment (selection bias)	Unclear risk	Judgement: no methods for allocation concealment described
Blinding of participants (performance bias)	High risk	Judgement: blinding not feasible Quote(s): none
Blinding of physicians / personnel	High risk	Judgement: blinding not feasible Quote(s): none
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Judgement: no methods for blinding the outcome assessor described
Incomplete outcome data (attrition bias) All outcomes	High risk	Judgement: high proportion of participants were lost to follow‐up Quote(s): "a total of 96 participants were recruited for this study, and completed the baseline neuropsychological evaluation. Of those, 74 participants completed the full treatment, 7 completed a partial portion of the treatment, and 15 did not complete any portion of the assigned treatment. The overall study attrition rate was 23%"
Selective reporting (reporting bias)	Low risk	Judgement: all outcomes described in the methods section are adequately addressed in the results section
Other bias	Low risk	Judgement: no other sources of bias are apparent