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. 2023 Jun 29;2023(6):CD013388. doi: 10.1002/14651858.CD013388.pub2

Clare 2010.

Study characteristics
Methods Single‐blind randomised controlled trial comparing cognitive rehabilitation with relaxation therapy and with no treatment
Participants 69 people (28 men, 41 women) with mild‐to‐moderate AD (MMSE score ≥ 18)
Interventions Cognitive rehabilitation: 8 weekly sessions (1 hour) addressing patient‐derived personal goals with components addressing the use of practical aids and strategies, techniques for learning new information, practice in maintaining attention, and techniques for stress management
Relaxation therapy: 8 weekly sessions where the therapist (same as CR group) used a structured treatment protocol to teach participants progressive muscle relaxation and breathing exercises
No treatment: participants had no contact with the research team between the initial and post‐intervention assessment
Outcomes Outcomes were reported at 8 weeks and 6 months. Cognitive outcomes for the person with dementia: memory (Rivermead Behavioural Memory Test‐II), language (verbal fluency), attention (Map Search, Elevator Counting, Elevator Counting With Distraction, from the Test of Everyday Attention), and perceived memory functioning (Memory Awareness Rating Scale, self‐ and carer‐rated)
Non‐cognitive outcomes for the person with dementia: goal performance and satisfaction (Canadian Occupational Performance Measure), functional abilities (Independent Living Scale Health and Safety subset), mood (Hospital Anxiety and Depression Scale), and quality of life (QoL‐AD, self and care partner‐rated)
fMRI was reported as a biomarker outcome for a subset of persons with dementia
Outcomes of the care partner: quality of life (World Health Organization Quality of Life Scale‐Brief version, WHOQOL‐BREF), general health (General Health Questionnaire‐12), mood (Hospital Anxiety and Depression Scale) and stress (Relatives’ Stress Scale)
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Randomization was conducted by an indepen‐ dent trials unit using a computer algorithm and was stratified for gender, age (up to 69 years versus 70 years and older), and geographical location (western, central, or eastern district of the catchment area)."
Allocation concealment (selection bias) Low risk Allocation concealment is intrinsic to a remote computerised randomisation system used in the study.
Blinding of participants and personnel (performance bias)
All outcomes High risk Participants and therapist were aware of their group allocation. The ratings of performance and satisfaction were subjective, and this could therefore potentially be biased by lack of participant blinding. Not clear whether other research personnel, including the statistician, were blinded to group allocation.
Blinding of outcome assessment (detection bias)
All outcomes Low risk All assessments were administered by blinded researchers. There is no reason to assume blinding was not effective, although no measure of blinding efficiency was reported.
Incomplete outcome data (attrition bias)
All outcomes Low risk Four participants withdrew from the study or died (2 in CR group, 1 in TAU, and 1 in relaxation therapy group), resulting in missing data. Reasons for exclusion were reported. Given the low number of missing data the risk of bias in this category has been rated as low.
Selective reporting (reporting bias) Low risk Authors indicated that the COPM was not re‐administered at 6‐month follow‐up because there was no evidence regarding its reliability at long‐term follow‐up. The COPM test‐retest reliability at a 1‐week period was cited in support of conducting the 8‐week post‐intervention rating.
Other bias Unclear risk No other significant sources of bias were identified.
Training of those delivering the intervention Low risk There is no detail on training, but authors stated that therapy was provided by an experienced Occupational Therapist and that adherence to therapy protocols was monitored through supervision and review of session and home‐practice records.
Intervention manual Unclear risk There is no detail on training, but authors stated that therapy was provided by an experienced Occupational Therapist and that adherence to therapy protocols was monitored through supervision and review of session and home‐practice records.