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Lifestyle coaching may ward off depression in widowed seniors

NCT ID NCT04016896

Prevention Sponsor: University of Pittsburgh Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a 12-week healthy lifestyle program could prevent depression in older adults who recently lost a spouse. Participants used digital tools to track sleep, meals, and activity, plus received weekly health coaching. The goal was to see if this approach reduces depression risk compared to standard support.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
healthy lifestyle program (digital monitoring of sleep, meals, physical activity; motivational health coaching; web-based feedback)
What this could lead to
If it works, this could offer a non-drug way to prevent depression in older adults after losing a spouse.
What could go wrong
This is a completed trial with 151 participants, so results are limited. The program requires active participation, and benefits may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

151 people

The number who actually took part.

Started

Oct 2020

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * aged 60 years and older; * spousally (or partner) bereaved up to 12 months (includes bereaved as a result of COVID-19); * at-risk for major depressive disorder (MDD), based on high-risk markers defined as subthreshold symptoms of depression (Hamilton Depression Rating Scale score of \> or = 9), together with absence of current MDD, post-traumatic stress disorder, or persistent complex bereavement disorder Exclusion Criteria: * current Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-5) criteria for syndromal mood, psychosis within the last 12 months; * dementia/cognitive impairment; Telephone Interview Cognitive Screening (TICS) \<19; * acute suicide risk; based on Herbeck et al. protocol for suicide risk management; * patients taking new psychotropic medications after spousal death to stabilize depression including antidepressants and benzodiazepines \>4 days/week for more than two months. Individuals who have been on a stable dose for at least 1 month and agree not to change during participation, unless it is medically necessary, will be included.

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Conditions

The condition(s) this trial relates to.

Depression depressive disorder major depressive disorder prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Depression

Contacts and locations

Locations

  • UPMC: WPIC- Bellefield Towers

    Pittsburgh, Pennsylvania, 15213, United States

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Other studies related to the condition(s) this trial covers.