A guided behavioral activation-based self-help intervention (INVOLVERA) for people with dementia and depression supported by informal caregivers: feasibility study and superiority randomized controlle

The overall purpose is to improve access to psychological support for people with dementia and depression.

We have developed INVOLVERA, a novel behavioral activation self-help intervention alongside people with dementia, informal caregivers, health and social care professionals, and non-profit organisations.

Following the Medical Research Council Complex Interventions Framework, aims are to:Study 1: explore clinical, methodological, and procedural uncertainties associated with the intervention and the design and conduct of a superiority randomized controlled trial of INVOLVERA plus treatment-as-usual for the treatment of depression in people with dementia in a single-arm feasibility study and embedded process evaluation (months 0-15)Study 2: examine the clinical and cost-effectiveness of INVOLVERA and assess intervention implementation, explore potential causal mechanisms, and identify contextual factors associated with outcome variation in a superiority randomized controlled trial with internal pilot and embedded process evaluation (months 10-48)To increase likelihood of real-world implementation, implementation issues are considered throughout.

To increase relevancy and value, a Public Advisory Group of people with dementia and informal caregivers work with the research team embedding public contribution into all research stages.INVOLVERA has potential to be an acceptable and effective solution to reduce health inequalities and improve the wellbeing of people with dementia.