Trials Journal

The trial protocol has been published in the Trials journal. Read and download the article.

Study Protocol

In the GREAT trial we compare cognitive rehabilitation (CR) to treatment as usual (TAU) by analysing how peoples’ everyday functioning and well-being change depending on what treatment they receive.

Key stages in the data collection process

First, potential participants (people with memory difficulties and their carers) are contacted to discuss the study. If both wish to continue with the study then the researcher completes several questionnaires and simple memory tasks with the participant. The carer is also asked to complete a short questionnaire.

Once this initial assessment (baseline) is complete, the researcher triggers randomisation and the participant is randomly assigned to receive either treatment as usual or cognitive rehabilitation (CR) with the therapist. CR is conducted in the participant’s home with the carer involved where possible. It consists of 10 therapy sessions over 3 months followed by 4 maintenance sessions over 6 months.

All participants are reassessed by the researcher 3 months after randomisation and again 6 months later. To ensure objectivity of the assessments, the researcher does not know which participants received CR and who continued with the usual treatment.

Key stages in the data collection process.

Research objectives

Upon the completion of data collection we will address the following objectives:

  1. We will find out how effective goal-oriented CR is compared to treatment as usual with regard to:
    • improving goal performance for people with memory difficulties,
    • improving quality of life, self-efficacy (perceived ability to influence one’s situation), mood, memory and thinking skills, and
    • producing benefits for carers by reducing stress and improving perceived health status and quality of life.
  2. We will determine whether CR is a cost-effective form of treatment in early-stage dementia by examining the benefits achieved in relation to the cost of providing the therapy.
  3. We will examine how the goal-oriented CR approach can most effectively be integrated into routine NHS provision.

In order to answer our research questions using appropriate statistical analyses, we need to recruit 480 people with early-stage dementia.

Main phases of the study.

Main phases of the study.