Alzheimers' Disease Clinical Trial
Official title:
Cognitive Behavioural Therapy for Persons With Mild Cognitive Impairment or Dementia in the Early Stages
A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's
disease, will be recruited from three hospitals in Norway.
The intervention is based on a standardized manual, and consists of 11 weekly one-hour
sessions, which are organized into six thematic modules.
The content of each session is specified by a treatment manual, which additionally consists
of worksheets, suggestions for homework in between sessions and letters to the caregivers
(the German manual: Werheid & Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner &
Tonga, not published). The treatment will be conducted by experienced health staff (nurses,
psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge
about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the
manual before study inception, participate in a two-day training seminar and will regularly
be supervised.
The control condition will be offered treatment as usual at the participating the memory
clinics.
The hypothesis is that the participants in the intervention group will report less
depression and increased self efficacy as compared with the control group.
We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to
examine the feasibility of the study protocol and do want to include these patients in the
study population.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment