Protocol for a collaborative randomised effectiveness trial of lay-delivered versus clinician-delivered behavioural activation in senior centres.

INTRODUCTION: 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). METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT04621877; ClinicalTrials.gov.

Understanding Psychological Distress and Protective Factors Amongst Older Adults During the COVID-19 Pandemic.

OBJECTIVES: This study examined the emotional distress and loneliness during COVID-19 and the roles of resiliency and activities. DESIGN: A cross-sectional national survey. SETTING: Amazon Mechanical Turk (mTurk) and Prolific Research Platforms. PARTICIPANTS: Five hundred and one U.S. dwelling English-speaking adults 60 years old and older. MEASUREMENTS: Participants completed an online survey with the PHQ-9; GAD-7; Short Health Anxiety Inventory; 3-item UCLA Loneliness scale; PROMIS measures of global health, instrumental, and emotional support; 10-item Connor-Davidson Resilience Scale; and COVID-19 needs assessment. RESULTS: Across the sample 13% reported moderate depressive symptoms, 9% reported moderate anxiety symptoms, and 26% endorsed being "lonely." The emotionally distressed group endorsed more loneliness, lower resiliency, less physical exercise, and worse physical health. The low Socio-Economic Status group endorsed less loneliness, less likely to engage in physical exercise and worse physical health.The lonely group endorsed less resilience, less physical exercise, and worse physical health. A multiple logistic regression found that resilience, socioeconomic status, and physical health were significant predictors of loneliness, whereas global health was the best predictor of emotional distress. CONCLUSIONS: Even after prolonged social distancing, older adults in this study did not report greater psychological distress compared to earlier studies of older adults during COVID-19. Older adults with lower SES, worse physical health, and less resiliency, were more likely to report more loneliness. It is this group that should be the focus of intervention.

Ethical and Regulatory Concerns in Pragmatic Clinical Trial Monitoring and Oversight.

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.