DepressionWELLNCT04016896
Depression Prevention in Older Spousally-bereaved Adults
A study testing WIdowed Elders' LIfestyle after Loss (WELL) in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder because of subthreshold symptoms of depression. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- WIdowed Elders' LIfestyle after Loss (WELL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 17 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC: WPIC- Bellefield Towers
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults
Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder 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, months 1 \& 2, post-intervention, and 3, 6,12, 18-months post-intervention. In addition, the investigators will include a subset of participants bereaved by COVID-19 (or suspected as bereaved by COVID-19). Participants in this subset will undergo the same research procedures as the main cohort. Participants in both the main cohort and subset determined to be fully eligible will be randomized into two groups with a total of: enhanced usual care (EUC; n=75) and WELL (WELL; n=75).
Read the detailed description
The primary aim of this R01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression in older acutely-bereaved adults. This trial began at the onset of the SARS-CoV-2/COVID-19 pandemic when grief and loss where ubiquitous and access to mourning services was limited. To test whether this intervention could reduce the severity of associated psychopathological conditions common after spousal death, we added secondary outcomes of anxiety, complicated grief, and posttraumatic stress.
- Conditions
- Depression
- Being tested
- WIdowed Elders' LIfestyle after Loss (WELL), Enhanced Usual Care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIdowed Elders' LIfestyle after Loss (WELL)Behavioural
Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks.
Enhanced Usual CareOther
Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Widowed Elders' Lifestyle after Loss (WELL) | Experimental | Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks. Receives: Behavioral: WIdowed Elders' LIfestyle after Loss (WELL) |
| Enhanced Usual Care | Active comparator | Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Depression Symptom Burden at 3 Months
Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression
Measured: baseline vs. 3 months
Secondary outcomes (3)
Change From Baseline in Anxiety Symptom Burden at 3 Months
Anxiety symptoms measured with the Generalized Anxiety Disorder - 7
Measured: baseline vs. 3 months
Change From Baseline in Complicated Grief Symptom Burden at 3 Months
Complicated grief symptoms measured with the Inventory of Complicated Grief
Measured: baseline vs. 3 months
Change From Baseline in Posttraumatic Stress Symptom Burden at 3 Months
Posttraumatic stress symptoms measured with the PTSD Checklist for DSM-5
Measured: baseline vs. 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start20 Oct 2020
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah T. Stahl, PhD, University of Pittsburgh
- Investigators
- sarah t stahl, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016896
- Sponsor's protocol ID
- STUDY19080030
- Other IDs
- R01MH118270
- Acronym
- WELL
- Status last verified
- Apr 2025
- First submitted
- 8 Jul 2019
- Last updated
- 28 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Stahl ST, Croswell E, Minhaj S, Gebara MA, Smagula SF, Reynolds CF, Rollman BL, Namdari J, Krafty RT. Effects of an internet-delivered behavioral self-monitoring intervention on depressive symptoms in older widowed adults: A randomized controlled trial. J Consult Clin Psychol. 2026 Sep;94(9):553-562. doi: 10.1037/ccp0001030.
PubMed 42911790Kazan J, Lyew T, Croswell E, Buysse DJ, Gebara MA, Karp JF, Krafty RT, Rashied AA, Reynolds CF 3rd, Rollman BL, Smagula SF, Stahl ST. 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. Contemp Clin Trials. 2023 Jan;124:107016. doi: 10.1016/j.cct.2022.107016. Epub 2022 Nov 19.
PubMed 36414207
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Healthy Lifestyle Intervention to Reduce Depression in Older Spousally-bereaved Adults
- ClinicalTrials.gov ID
- NCT04016896
- Acronym / sponsor ID
- WELL / STUDY19080030
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using an indicated prevention approach, investigators propose to enroll 150 spousally-bereaved adults aged 60 years and older in the first 12 months after spousal death who are at high risk for major depression disorder 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, months 1 \& 2, post-intervention, and 3, 6,12, 18-months post-intervention. In addition, the investigators will include a subset of participants bereaved by COVID-19 (or suspected as bereaved by COVID-19). Participants in this subset will undergo the same research procedures as the main cohort. Participants in both the main cohort and subset determined to be fully eligible will be randomized into two groups with a total of: enhanced usual care (EUC; n=75) and WELL (WELL; n=75).
Detailed description
The primary aim of this R01 application is to test the efficacy of a new behavioral intervention that targets the timing and regularity of sleep, meals, and physical activity to stabilize circadian rhythms, for reducing symptoms of depression in older acutely-bereaved adults. This trial began at the onset of the SARS-CoV-2/COVID-19 pandemic when grief and loss where ubiquitous and access to mourning services was limited. To test whether this intervention could reduce the severity of associated psychopathological conditions common after spousal death, we added secondary outcomes of anxiety, complicated grief, and posttraumatic stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Widowed Elders' Lifestyle after Loss (WELL) | Experimental | Behavioral: WIdowed Elders' LIfestyle after Loss (WELL)Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks. |
| Enhanced Usual Care | Active comparator | Other: Enhanced Usual CareHealth education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WIdowed Elders' LIfestyle after Loss (WELL)Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks. | Behavioural | Widowed Elders' Lifestyle after Loss (WELL) |
| Enhanced Usual CareHealth education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks. | Other | Enhanced Usual Care |
Primary outcome
Change From Baseline in Depression Symptom Burden at 3 Months
Time frame: baseline vs. 3 months
Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression
3 secondary outcomes
Change From Baseline in Anxiety Symptom Burden at 3 Months
Time frame: baseline vs. 3 months
Change From Baseline in Complicated Grief Symptom Burden at 3 Months
Time frame: baseline vs. 3 months
Change From Baseline in Posttraumatic Stress Symptom Burden at 3 Months
Time frame: baseline vs. 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42911790Stahl ST, Croswell E, Minhaj S, Gebara MA, Smagula SF, Reynolds CF, Rollman BL, Namdari J, Krafty RT. Effects of an internet-delivered behavioral self-monitoring intervention on depressive symptoms in older widowed adults: A randomized controlled trial. J Consult Clin Psychol. 2026 Sep;94(9):553-562. doi: 10.1037/ccp0001030.
- Derived from this study: PubMed 36414207Kazan J, Lyew T, Croswell E, Buysse DJ, Gebara MA, Karp JF, Krafty RT, Rashied AA, Reynolds CF 3rd, Rollman BL, Smagula SF, Stahl ST. 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. Contemp Clin Trials. 2023 Jan;124:107016. doi: 10.1016/j.cct.2022.107016. Epub 2022 Nov 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sarah t stahl, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIdowed Elders' LIfestyle after Loss (WELL) in people with Depression, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Depression Symptom Burden at 3 Months (time frame: baseline vs. 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.