Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects.

Background And Objective: The post-trial follow-up (PTFU) phase of a clinical trial can provide important information on maintenance of intervention effects. However, approaches for the PTFU are rarely described. This short communication describes our process for PTFU that involved recontacting older subjects who participated in a clinical trial between 2015 and 2019.

Incorporating technology in research with older bereaved adults: Lessons learned from conducting an internet-based randomized controlled trial.

Objective: Digital health interventions (DHI) involve multiple interactions between the user, technology platform, and study team, posing challenges for implementation. This paper describes the lessons learned while implementing an internet-based randomized controlled trial (RCT) for reducing depression symptom burden in older acutely-bereaved adults.

Methods: The RCT was entitled "Widowed Elders' Lifestyle after Loss" (or WELL), which compared the efficacy of a DHI to an enhanced usual care (EUC) for reducing depression symptoms in adults 60+ years who lost their spouse/life partner within the previous 12 months.

A digital health intervention to stabilize the 24-hour rhythm of sleep, meals, and physical activity for reducing depression among older bereaved spouses: Protocol for a randomized controlled trial.

Background: Despite the high prevalence of depression and disruption to 24-h sleep-wake routines following the death of a spouse in late-life, no bereavement interventions have been developed to re-entrain a regular sleep-wake routine among older widow(er)s. We describe the rationale and methodology of the NIH-funded WELL Study (Widowed Elders' Lifestyle after Loss), a randomized controlled trial (RCT) comparing the efficacy of a digital health intervention (DHI) to enhanced usual care (EUC) arm for reducing depression symptoms in older spousally-bereaved adults.

Methods: We will randomize approximately 200 recently bereaved (<12 months) adults aged 60+ years to one of two 12-week interventions: digital monitoring of the timing and regularity of sleep, meals, and physical activity plus weekly motivational health coaching; or enhanced usual care consisting of weekly telephone calls and similar assessment schedules.

μ Opioid Antagonist Naltrexone Partially Abolishes the Antidepressant Placebo Effect and Reduces Orbitofrontal Cortex Encoding of Reinforcement.

Background: Like placebo analgesia, the antidepressant placebo effect appears to involve cortical and subcortical endogenous opioid signaling, yet the mechanism through which opioid release affects mood remains unclear. The orbitofrontal cortex (OFC)-which integrates various attributes of a stimulus to predict associated outcomes-has been implicated in placebo effects and is rich in μ opioid receptors. We hypothesized that naltrexone blockade of μ opioid receptors would blunt OFC-dependent antidepressant placebo effects.