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

Joseph Kazan, Thandi Lyew, Emilee Croswell, Daniel J. Buysse, Marie Anne Gebara, Jordan F. Karp, Robert T. Krafty, Ammar A. Rashied, Charles F. Reynolds, Bruce L. Rollman, Stephen F. Smagula, Sarah T. Stahl

Research output: Contribution to journalArticlepeer-review

Abstract

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. Participants will complete self-report and clinical assessments at baseline, post-intervention, and 3-, 6-, and 12-months post-intervention, and objective actigraphic assessments of their 24-h rest-activity rhythm (RAR) at baseline and 1-, 2-, and 3-months during the intervention. The primary outcome is change in depression symptoms burden (using the Hamilton Rating Scale for Depression) from pre- to post-intervention and over 12 months of follow-up. Discussion: WELL Study findings will inform the development of widely generalizable and scalable technology-based interventions to support bereaved spouses in community-based settings. Clinical http://Trials.gov

Original languageEnglish (US)
Article number107016
JournalContemporary Clinical Trials
Volume124
DOIs
StatePublished - Jan 2023

Keywords

  • Aging
  • Circadian rhythms
  • Internet-based
  • Online intervention

ASJC Scopus subject areas

  • Pharmacology (medical)

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