# Efficacy of a Healthy Lifestyle Intervention to Prevent Depression in Older Spousally-bereaved Adults

> **NIH NIH R01** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2021 · $554,863

## Abstract

PROJECT SUMMARY/ABSTRACT
Apart from the emotional strain of losing a spouse, there are profound changes to bereaved individuals' daily
routine; adults suddenly feel no reason to get up, go to bed, eat meals, or engage in activity at particular times
of the day. Disruption of these key social timekeepers, or “zeitgebers”, disrupt the stability of circadian rhythms,
placing these individuals at high risk for mood disorders like major depressive disorder (MDD) and other adverse
health consequences related to poor self-care. Preventing MDD has public health importance due to its
prevalence and associated physical disability, morbidity, and excess mortality. Preliminary data from the PI's
K01 award (MH103467) show that a behavioral intervention that uses technology and motivational health
coaching to target the stability of individuals' zeitgebers (sleep, meals, activity) is feasible and acceptable to
older spousally-bereaved adults who are high risk for MDD because of subthreshold symptoms of depression.
Feasibility analyses demonstrate a preliminary efficacy signal (with respect to reducing depression) and show
that this intervention stabilizes circadian rhythms (the “target” or hypothesized mechanism of action). Results of
this pilot study support moving forward with a full-scale efficacy trial. The primary aim of this R01 application is
to test the efficacy of a technology-based behavioral intervention that targets the timing and regularity of sleep,
meals, and physical activity for stabilizing circadian rhythms, to reduce symptoms of depression among older
spousally-bereaved adults. Using an indicated prevention approach, we propose to enroll 150 spousally-
bereaved adults aged 60 years and older in the first 6 months after spousal death who are at high risk for MDD
because of subthreshold symptoms of depression. A confirmatory efficacy trial will be conducted in which
participants will be randomly assigned to (a) self-monitor sleep, meals, and physical activity for 12 weeks using
digital monitoring plus motivational health coaching (WELL; n=75); or (b) enhanced usual care (EUC, usual care
plus study assessments, n=75). Objective actigraphic measures of the 24-hour pattern of day and nighttime
activity – known as the rest-activity rhythm – will be measured to evaluate circadian rhythms as a mediator of
treatment outcomes. Participants will be assessed at baseline, post-intervention, and 3-, 6-, and 12-months post-
intervention. Results from this trial, whether positive or negative, will provide definitive decisions about future
intervention development (i.e., effectiveness testing or dissemination of the intervention). The proposed trial
aligns with Strategic Objective 3 (Strive for Prevention) and is responsive to research priority 3.2 by “developing
context dependent interventions that target core mechanisms, including those that are common across mental
illnesses, related to the prodromal, recent onset, and chronic stages of mental illness, in...

## Key facts

- **NIH application ID:** 10165830
- **Project number:** 5R01MH118270-03
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Sarah T Stahl
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $554,863
- **Award type:** 5
- **Project period:** 2019-08-23 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10165830

## Citation

> US National Institutes of Health, RePORTER application 10165830, Efficacy of a Healthy Lifestyle Intervention to Prevent Depression in Older Spousally-bereaved Adults (5R01MH118270-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10165830. Licensed CC0.

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