Validation of a Multidomain Neuropsychological Intervention for Individuals at Risk of Dementia: the REMINDER Program

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Until now, neuropsychological interventions aimed to optimize cognitive function and to have functional impact in individuals at risk of AD (MCI patients) were scarce in validity studies. While some RCTs have been developed in cognitive training interventions, comparative studies of merged interventions (cognitive, social and behavioral stimulation) with adequate control groups are absent, diminishing the professionals' trust on the adoption of these interventions for supporting patients. As such, the present proposal will develop a validation trial testing a multicomponent neuropsychological intervention (REMINDER), based on personal development, cognitive compensatory aids, meaningful goals setting, and behavior change techniques. The investigators will analyze its short/long-term gains and AD conversion rates. By aiming to provide a good validation study for REMINDER, the investigators will examine neurobiological, neurocognitive and functional outcomes of this intervention in comparison with an active control group (psychoeducation) in order to foster an effective outcome assessment of an intervention for individuals at risk of AD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: t
View:

• Age 60 or older

• CAIDE dementia risk score \>8

• Cognitive function: absence of significant cognitive impairment as per the Addenbrooke's Cognitive Examination-REVISED

• Free of physical disabilities that preclude participation in the study

• Willing to complete all study-related activities for 12 weeks

Locations
Other Locations
Portugal
Faculty of Psychology and Educational Sciences
RECRUITING
Coimbra
Contact Information
Primary
Ana Rita Silva, PhD
anaritaess@fpce.uc.pt
+351962779695
Backup
University of Coimbra
cineicc@fpce.uc.pt
+351 239851450
Time Frame
Start Date: 2022-04-01
Estimated Completion Date: 2026-10
Participants
Target number of participants: 400
Treatments
Experimental: REMINDER program online
The REMINDER program in this arm will be delivered by videoconferencing. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation
Experimental: REMINDER program face-to-face
The REMINDER program in this arm will be delivered face to face. It will integrate 20 sessions (with approximate length of 45-60 min), therapist-mediated, carried out twice a week, over a period of 12 weeks. Psychoeducation sessions and part of the reminiscence and memory strategies training sessions will be facilitated in groups, as means to promote social support and modeling, and the remaining will be individual sessions. Several activities aimed to promote personal development and definition and achievement of meaningful goals will be included in the program, and the program will be manualized to facilitate its future dissemination and implementation
Sham_comparator: Brain psychoeducation program
The control condition will have the same length as the experimental harms, including 20 psychoeducation sessions, with information regarding dementia modifiable risk factors, information on healthy lifestyles, and brain health promotion.
Related Therapeutic Areas
Sponsors
Collaborators: Fundação para a Ciência e a Tecnologia
Leads: University of Coimbra

This content was sourced from clinicaltrials.gov