Individual goal-oriented cognitive rehabilitation to improve everyday functioning for people with early-stage dementia: a multi-centre randomised controlled trial (the GREAT trial)

YesObjectives: To determine whether individual goal-oriented cognitive rehabilitation (CR) improves everyday functioning for people with mild-to-moderate dementia. Design and methods: Parallel group multi-centre single-blind randomised controlled trial (RCT) comparing CR added to usual treatment (CR) with usual treatment alone (TAU) for people with an ICD-10 diagnosis of Alzheimer’s, vascular or mixed dementia and mild-to-moderate cognitive impairment (MMSE score ≥ 18), and with a family member willing to contribute. Participants allocated to CR received ten weekly sessions over three months and four maintenance sessions over six months. Participants were followed up three and nine months post-randomisation by blinded researchers. The primary outcome was self-reported goal attainment at three months. Secondary outcomes at three and nine months included informant-reported goal attainment, quality of life, mood, self-efficacy, and cognition, and study partner stress and quality of life. Results: We randomised (1:1) 475 people with dementia; 445 (CR=281) were included in the intention to treat analysis at three months, and 426 (CR=208) at nine months. At three months there were statistically-significant large positive effects for participant-rated goal attainment (d=0.97, 95% CI 0.75 to 1.19), corroborated by informant ratings (d=1.11, 0.89 to 1.34). These effects were maintained at nine months for both participant (d=0.94, 0.71 to 1.17) and informant ratings (d=0.96, 0.73 to 1.2). The observed gains related to goals directly targeted in the therapy. There were no significant differences in secondary outcomes. Conclusions: Cognitive rehabilitation enables people with early-stage dementia to improve their everyday functioning in relation to individual goals targeted in the therapy.National Institute for Health, Health Technology Assessment Programme, Grant/Award Number: 11/15/0