Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01MH118270 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Enhanced Usual Care | Active Comparator | Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WIdowed Elders' LIfestyle after Loss (WELL) | Behavioral | Digital monitoring of sleep, meals, physical activity (daily); motivational health coaching (weekly); and web-based performance feedback (in real-time) for 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Depression Symptom Burden at 3 Months | Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression | baseline vs. 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Anxiety Symptom Burden at 3 Months | Anxiety symptoms measured with the Generalized Anxiety Disorder - 7 | baseline vs. 3 months |
| Change From Baseline in Complicated Grief Symptom Burden at 3 Months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| sarah t stahl, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC: WPIC- Bellefield Towers | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36414207 | Derived | Kazan 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. |
Not provided
Not provided
Participants were randomized 1:1 to intervention or control.
Participants were recruited from university-affiliated research registries, social media, local hospice organizations, grief support groups, and specialty-care medicine at the University of Pittsburgh Medical Center.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Widowed Elders' Lifestyle After Loss (WELL) | Behavioral self-monitoring of sleep, meals, and physical activity via digital diaries (daily); motivational health coaching (weekly); and performance feedback on health goals (in real time), for 3 months. |
| FG001 | Enhanced Usual Care | Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Widowed Elders' Lifestyle After Loss (WELL) | Behavioral self-monitoring of sleep, meals, and physical activity via digital diaries (daily); motivational health coaching (weekly); and performance feedback on health goals (in real time) for 3 months. |
| BG001 | Enhanced Usual Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Self-reported age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Depression Symptom Burden at 3 Months | Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression | Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3. | Posted | Mean | Standard Deviation | score on a scale | baseline vs. 3 months |
|
from enrollment until end of intervention, up to 3 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Widowed Elders' Lifestyle After Loss (WELL) | Behavioral self-monitoring of sleep, meals, and physical activity via digital diaries (daily); motivational health coaching (weekly); and performance feedback on health goals (in real time) for 3 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah T. Stahl, PhD | University of Pittsburgh | 4122466003 | sts80@pitt.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 3, 2020 | Jan 12, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 22, 2024 | Dec 11, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Enhanced Usual Care | Other | Health education, referral to mental health support, and telephone-delivered support (weekly) for 12 weeks. |
|
Complicated grief symptoms measured with the Inventory of Complicated Grief
| 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 | baseline vs. 3 months |
Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Self-reported sex | Count of Participants | Participants |
|
| Race (NIH/OMB) | Self-reported race | Count of Participants | Participants |
|
| Depressive symptoms | Total score on the Hamilton Rating Scale for Depression. Score range: 0-52 with higher scores indicate greater depression severity. | Mean | Standard Deviation | score on a scale |
|
| Anxiety symptoms | Total score on the Generalized Anxiety Disorder - 7. Score range = 0-21 with higher scores indicating greater anxiety severity. | Mean | Standard Deviation | score on a scale |
|
| Complicated grief symptoms | Total score on the Inventory of Complicated Grief. Score range: 0-76 with higher scores indicating greater complicated grief severity. | Mean | Standard Deviation | score on a scale |
|
| Posttraumatic stress symptoms | Total score on the PTSD Checklist for DSM-5. Score range = 0-80 with higher scores indicating greater PTSD symptom severity | Mean | Standard Deviation | score on a scale |
|
Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
|
|
|
| Secondary | Change From Baseline in Anxiety Symptom Burden at 3 Months | Anxiety symptoms measured with the Generalized Anxiety Disorder - 7 | Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3. | Posted | Mean | Standard Deviation | score on a scale | baseline vs. 3 months |
|
|
|
|
| Secondary | Change From Baseline in Complicated Grief Symptom Burden at 3 Months | Complicated grief symptoms measured with the Inventory of Complicated Grief | Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3. | Posted | Mean | Standard Deviation | score on a scale | baseline vs. 3 months |
|
|
|
|
| Secondary | Change From Baseline in Posttraumatic Stress Symptom Burden at 3 Months | Posttraumatic stress symptoms measured with the PTSD Checklist for DSM-5 | Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3. | Posted | Mean | Standard Deviation | score on a scale | baseline vs. 3 months |
|
|
|
|
| 0 |
| 75 |
| 4 |
| 75 |
| 34 |
| 75 |
| EG001 | Enhanced Usual Care | Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months | 0 | 76 | 4 | 76 | 35 | 76 |
| Respiratory illness | Infections and infestations | Systematic Assessment |
|
| Personal injury | Cardiac disorders | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
|
| Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
|
| Surgery | Surgical and medical procedures | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
|
| Mood/anxiety disorder | Psychiatric disorders | Systematic Assessment |
|
| Personal injury | General disorders | Systematic Assessment |
|
| Alcohol use disorders | Psychiatric disorders | Systematic Assessment |
|
| Arthritis and/or Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Infections | Infections and infestations | Systematic Assessment |
|
| Bladder Infection | Renal and urinary disorders | Systematic Assessment |
|
| Nervous system disorders | Nervous system disorders | Systematic Assessment |
|
| Gastrointestinal problems | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| Cancer | Blood and lymphatic system disorders | Systematic Assessment |
|
| Lupus | Immune system disorders | Systematic Assessment |
|
| Cardiovascular problems | Cardiac disorders | Systematic Assessment |
|
Not provided
Not provided