Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural...

Depression is common among community-dwelling older adults who make use of senior centre services yet remains undertreated due to a lack of acceptable and available treatments. Emerging evidence suggests that lay health providers can offer psychosocial interventions for mental health disorders experienced by older adults. We developed a streamlined Behavioural Activation intervention (called 'Do More, Feel Better'; DMFB) to be delivered by older adult volunteers and propose to compare its effectiveness to that of clinician-delivered behavioural activation (BA).

This study is a type I collaborative randomised effectiveness trial testing the effect of DMFB in comparison to BA among 288 senior centre clients (aged 60+). Participant clients will be recruited from 6 Seattle, 6 New York City and 6 Tampa area senior centres serving economically and ethnically diverse communities. Primary outcomes will be increased activity level (target) and decreased depressive symptoms. Secondary outcomes will be functioning and client satisfaction, and an exploratory outcome will be treatment fidelity.

The study received ethics approval from the University of Washington Institutional Review Board (STUDY00011434). Client, volunteer and clinician participants will all provide informed consent for study procedures through in-person or remote contact with investigators. Results of this study will be presented in peer-reviewed journals and at professional conferences.

NCT04621877; ClinicalTrials.gov.