Efficacy of an evidence-based cognitive stimulation therapy programme for people with dementia: randomised controlled trial. Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial. A randomized, two-year study of the efficacy of cognitive intervention on elderly people: the Donostia Longitudinal Study. A controlled clinical trial on the effects of motor intervention on balance and cognition in institutionalized elderly patients with dementia. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Efficacy of a psychoeducative group program for caregivers of demented persons living at home: a randomized controlled trial. Reality orientation therapy combined with cholinesterase inhibitors in Alzheimer's disease: randomised controlled trial. Goal-oriented cognitive rehabilitation for people with early-stage Alzheimer disease: a single-blind randomized controlled trial of clinical efficacy. Randomized controlled trial of cognitive behaviour therapy for repeated consultations for medically unexplained complaints: a feasibility study in Sri Lanka.
A recent Cochrane review of reality orientation therapy identified the need for large, well-designed, multi-centre trials.
                To test the hypothesis that cognitive stimulation therapy (CST) for older people with dementia would benefit cognition and quality of life.
                A single-blind, multi-centre, randomised controlled trial recruited 201 older people with dementia. The main outcome measures were change in cognitive function and quality of life. An intention-to-treat analysis used analysis of covariance to control for potential variability in baseline measures.
                One hundred and fifteen people were randomised within centres to the intervention group and 86 to the control group. At follow-up the intervention group had significantly improved relative to the control group on the Mini-Mental State Examination (P=0.044), the Alzheimer's Disease Assessment Scale - Cognition (ADAS-Cog) (P=0.014) and Quality of Life - Alzheimer's Disease scales (P=0.028). Using criteria of 4 points or more improvement on the ADAS-Cog the number needed to treat was 6 for the intervention group.
                The results compare favourably with trials of drugs for dementia. CST groups may have worthwhile benefits for many people with dementia. Dementia is a highly invalidating condition and, given the progressive aging of the population, one of the major issues that health systems will have to face in future years. Recently there has been an increase in the potential of diagnostic tools and pharmacological treatments for dementia; moreover, considerable interest has been expressed regarding non pharmacological interventions. However, the current evidence in support of non pharmacological treatments in patients affected by dementia still does not allow to draw definitive conclusions on what is the most effective treatment to apply, largely because of methodological difficulties and limitations of the studies so far carried out due to the complex nature of the disease. To address this need, we carried out a single blind randomized controlled study on the efficacy of computer cognitive rehabilitation in patients with mild cognitive decline. We here present preliminary data on 11 patients with diagnosis of Alzheimer's Disease (AD) and mild cognitive decline randomly assigned to treatment (a) or control (b) condition (i.e. specific vs. aspecific treatment). The specific treatment (a) consisted in a cycle of 12 individual sessions of computer exercises, while the control condition (b) consisted in sessions of semi-structured interviews with patients, conducted with the same frequency and time period as (a). Cognitive, behavioural and functional assessment was performed by an expert evaluator, blinded to the patients' group allocation. Preliminary results show a significant performance decline only in the control group at the 9-month follow-up compared to both baseline and the 3-month follow-up. Our results suggest that computer based cognitive training in patients with AD and mild cognitive decline is effective at least in delaying the continuous progression of cognitive impairment in AD. Research on non-pharmacological therapies (cognitive rehabilitation) in old age has been very limited, and most has not considered the effect of interventions of this type over extended periods of time.
                To investigate a new cognitive therapy in a randomized study with elderly people who did not suffer cognitive impairment.
                The efficacy of this therapy was evaluated by means of post-hoc analysis of 238 people using biomedical, cognitive, behavioural, quality of life (QoL), subjective memory, and affective assessments.
                Scores for learning potential and different types of memory (working memory, immediate memory, logic memory) for the treatment group improved significantly relative to the untreated controls.
                The most significant finding in this study was that learning potential continued at enhanced levels in trained subjects over an intervention period lasting two years, thereby increasing rehabilitation potential and contributing to successful ageing. To analyse the effects of two interventions on the cognition and balance of institutionalized elderly people with mixed dementia.
                Fifty-four participants were allocated into three groups. Group 1 was assisted by an interdisciplinary programme comprising physiotherapy, occupational therapy and physical education. A physiotherapist alone carried out the intervention in group 2. Group 3 was considered as control. Assessors were blinded to guarantee the absence of bias. Cognitive functions were analysed with the Mini-Mental State Examination and the Brief Cognitive Screening Battery. Balance was assessed with the Berg Balance Scale and the Timed Get-Up-and-Go Test. Multiple analysis of variance (MANOVA) was used to test possible main effects of the interventions.
                The results showed benefits on the balance of subjects in both groups 1 (F=3.9, P<0.05) and 2 (F=3.1, P<0.05), compared with group 3. MANOVA did not indicate benefits on the cognitive functions between groups 1 and 3 (F=1.1, P>0.05) and groups 2 and 3 (F=1.6, P>0.05). However, univariate analysis indicated some benefits of the interdisciplinary intervention on two specific domains measured by the Brief Cognitive Screening Battery (F=26.5, P<0.05; F=4.4, P<0.05).
                Six months of multidisciplinary or physiotherapeutic intervention were able to improve a person's balance. Although global cognition did not improve through treatment, when the intervention was carried out on a multidisciplinary basis we observed an attenuation in the decline of global cognition on two specific cognitive domains. Exercises applied in different contexts may have positive outcomes for people with dementia. The efficacy of a cognitive intervention consisting of training in face-name associations, spaced retrieval, and cognitive stimulation was tested in a sample of 37 patients (16 men, 21 women) with probable Alzheimer disease (AD). Patients with AD were randomly assigned to receive either the cognitive intervention or a mock (placebo) intervention for 5 weeks. The placebo group then crossed over to receive the intervention. During the intervention, AD patients showed significant improvement in recall of personal information, face-name recall, and performance on the Verbal Series Attention Test. Improvement did not generalize to additional neuropsychologic measures of dementia severity, verbal memory, visual memory, word generation, or motor speed, or to caregiver-assessed patient quality of life. Results suggest that although face-name training, spaced retrieval, and cognitive stimulation may produce small gains in learning personal information and on a measure of attention, improvement does not generalize to overall neuropsychologic functioning or patient quality of life. To test the efficacy of a psychoeducative group program for informal caregivers of persons with dementia.
                The study was a multicenter randomized controlled trial. Randomization was stratified according to sex and kinship. Participants randomized to the control group were referred to the traditional support groups. Participants in the study group had fifteen 2-hr weekly sessions focusing on stress appraisal and coping. Eligible participants (primary caregivers of community-dwelling persons with dementia) were blindly assessed before the randomization and after 16 weeks on the following measures: frequency and reactions to behavioral problems (primary outcome), burden, psychological distress, anxiety, perceived social support, and personal efficacy.
                A total of 158 participants were randomized to the study (n = 79) and control (n = 79) groups in 12 successive waves. Results show that study participants presented a 14% decrease in their reactions to the behavioral problems of the care-receivers as opposed to a 5% decrease in the control group ( p =.04). The frequency of behavior problems also decreased ( p =.06), as did the cross-product frequency/reaction ( p =.02). There was no significant effect on the secondary outcome variables.
                This is one of the first studies showing a significant effect of this type of support group program on the caregivers of participants with dementia. Reality orientation therapy combined with cholinesterase inhibitors has not been evaluated in patients with Alzheimer's disease.
                To perform such an evaluation.
                We randomly assigned 79 of 156 patients treated with donepezil to receive a reality orientation programme. Caregivers of the treatment group were trained to offer the programme at home 3 days a week, 30 min/day, for 25 consecutive weeks, and were invited to stimulate and involve patients in reality-based communication.
                The treatment group showed a slight improvement in Mini-Mental State Examination (MMSE) scores (mean change +0.2, s.e.=0.4) compared with a decline in the control group (mean change -1.1, s.e.=0.4; P=0.02). Similarly for the Alzheimer's Disease Assessment Scale--Cognition (treatment group mean change +0.4, s.e.=0.8; control group -2.5, s.e.=0.8; P=0.01). The intervention had an equal effect on cognition in those with mild (MMSE score > or = 20) and moderate (score <20) dementia. No significant effect was observed for behavioural and functional outcomes.
                Reality orientation enhances the effects of donepezil on cognition in Alzheimer's disease. To provide evidence regarding the clinical efficacy of cognitive rehabilitation (CR) in early-stage Alzheimer disease (AD).
                Single-blind randomized controlled trial comparing CR with relaxation therapy and no treatment.
                Outpatient, community-based setting.
                Sixty-nine individuals (41 women, 28 men; mean age 77.78 years, standard deviation 6.32, range = 56-89) with a diagnosis of AD or mixed AD and vascular dementia and a Mini-Mental State Examination score of 18 or above, and receiving a stable dose of acetylcholinesterase-inhibiting medication. Forty-four family carers also contributed.
                Eight weekly individual sessions of CR consisting of personalized interventions to address individually relevant goals supported by components addressing practical aids and strategies, techniques for learning new information, practice in maintaining attention and concentration, and techniques for stress management.
                The primary outcomes were goal performance and satisfaction, assessed using the Canadian Occupational Performance Measure. Questionnaires assessing mood, quality of life and career strain, and a brief neuropsychological test battery were also administered. A subset of participants underwent functional magnetic resonance imaging (fMRI).
                CR produced significant improvement in ratings of goal performance and satisfaction, whereas scores in the other two groups did not change. Behavioral changes in the CR group were supported by fMRI data for a subset of participants.
                The findings support the clinical efficacy of CR in early-stage AD. CR offers a means of assisting people with early-stage AD and their families in managing the effects of the condition. Research on the management and the outcome of treatment of medically unexplained symptoms is very limited. Development of simple but effective techniques for treatment and demonstration of their effectiveness when applied in primary health care are needed.
                A randomized controlled trial was carried out with follow-up assessments at 3 months after baseline assessments using the Short Explanatory Model Interview (SEMI), General Health Questionnaire (GHQ-30), Bradford Somatic Inventory (BSI) and patient satisfaction on a visual analogue scale. The study was carried out in a general out-patient clinic in Sri Lanka. The intervention group received six, 30 min sessions based on the principles of cognitive behavioural therapy over a period of 3 months. The control group received standard clinical care.
                Eighty patients out of the 110 patients referred, were eligible. Sixty-eight were randomly allocated equally to the control and treatment groups. All 34 in the treatment group accepted the treatment offer and 22 completed between three and six sessions. At 3 months, 24 in the treatment and 21 in the control group completed follow-up assessments. Intention-to-treat analysis revealed significant differences in mean scores of outcome measures (adjusted for baseline scores) between control and intervention groups respectively--complaints 6.1 and 3.8 (P = 0.001), GHQ 10.4 and 6.3 (P = 0.04), BSI score 15.6 and 132 (P < 0-01), visits 7.9 and 3.1 (P = 0.004).
                Intervention based on cognitive behavioural therapy is feasible and acceptable to patients with medically unexplained symptoms from a general out-patients clinic in Sri Lanka. It had a significant effective in reducing symptoms, visits and distress, and in increasing patient satisfaction.
There is insufficient evidence from randomised trials to allow any conclusion about the efficacy of validation therapy for people with dementia or cognitive impairment.