Trial Outcomes & Findings for Depression Prevention in Older Spousally-bereaved Adults (NCT NCT04016896)

NCT ID: NCT04016896

Last Updated: 2026-01-28

Results Overview

Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression

Recruitment status

COMPLETED

Study phase

Target enrollment

151 participants

Primary outcome timeframe

baseline vs. 3 months

Results posted on

2026-01-28

Participant Flow

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.

Participants were randomized 1:1 to intervention or control.

Participant milestones

Participant milestones
Measure	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.	Enhanced Usual Care Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Overall Study STARTED	75	76
Overall Study COMPLETED	58	66
Overall Study NOT COMPLETED	17	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Depression Prevention in Older Spousally-bereaved Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Widowed Elders' Lifestyle After Loss (WELL) n=75 Participants 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.	Enhanced Usual Care n=76 Participants Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months	Total n=151 Participants Total of all reporting groups
Age, Continuous	70.3 years STANDARD_DEVIATION 6.8 • n=41 Participants	70.3 years STANDARD_DEVIATION 7.2 • n=1581 Participants	70.3 years STANDARD_DEVIATION 7.0 • n=4626 Participants
Sex: Female, Male Female	60 Participants n=41 Participants	61 Participants n=1581 Participants	121 Participants n=4626 Participants
Sex: Female, Male Male	15 Participants n=41 Participants	15 Participants n=1581 Participants	30 Participants n=4626 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Asian	0 Participants n=41 Participants	2 Participants n=1581 Participants	2 Participants n=4626 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Black or African American	9 Participants n=41 Participants	6 Participants n=1581 Participants	15 Participants n=4626 Participants
Race (NIH/OMB) White	66 Participants n=41 Participants	68 Participants n=1581 Participants	134 Participants n=4626 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Depressive symptoms	12.6 score on a scale STANDARD_DEVIATION 12.3 • n=41 Participants	3.0 score on a scale STANDARD_DEVIATION 3.2 • n=1581 Participants	12.4 score on a scale STANDARD_DEVIATION 3.0 • n=4626 Participants
Anxiety symptoms	4.1 score on a scale STANDARD_DEVIATION 3.5 • n=41 Participants	2.9 score on a scale STANDARD_DEVIATION 2.9 • n=1581 Participants	3.5 score on a scale STANDARD_DEVIATION 3.3 • n=4626 Participants
Complicated grief symptoms	23.4 score on a scale STANDARD_DEVIATION 11.1 • n=41 Participants	21.9 score on a scale STANDARD_DEVIATION 10.8 • n=1581 Participants	22.7 score on a scale STANDARD_DEVIATION 10.9 • n=4626 Participants
Posttraumatic stress symptoms	15.4 score on a scale STANDARD_DEVIATION 10.3 • n=41 Participants	14.3 score on a scale STANDARD_DEVIATION 10.6 • n=1581 Participants	14.8 score on a scale STANDARD_DEVIATION 10.4 • n=4626 Participants

PRIMARY outcome

Timeframe: baseline vs. 3 months

Population: Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3.

Depression symptoms measured by the clinician administered Hamilton Rating Scale for Depression

Outcome measures

Outcome measures
Measure	Widowed Elders' Lifestyle After Loss (WELL) n=58 Participants 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).	Enhanced Usual Care n=66 Participants Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Change From Baseline in Depression Symptom Burden at 3 Months	5.6 score on a scale Standard Deviation 4.0	7.4 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: baseline vs. 3 months

Population: Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3.

Anxiety symptoms measured with the Generalized Anxiety Disorder - 7

Outcome measures

Outcome measures
Measure	Widowed Elders' Lifestyle After Loss (WELL) n=58 Participants 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).	Enhanced Usual Care n=66 Participants Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Change From Baseline in Anxiety Symptom Burden at 3 Months	1.6 score on a scale Standard Deviation 2.5	2.1 score on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: baseline vs. 3 months

Population: Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3.

Complicated grief symptoms measured with the Inventory of Complicated Grief

Outcome measures

Outcome measures
Measure	Widowed Elders' Lifestyle After Loss (WELL) n=58 Participants 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).	Enhanced Usual Care n=66 Participants Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Change From Baseline in Complicated Grief Symptom Burden at 3 Months	16.5 score on a scale Standard Deviation 9.1	16.5 score on a scale Standard Deviation 9.7

SECONDARY outcome

Timeframe: baseline vs. 3 months

Population: Of the 75 randomized to intervention, 58 were retained to month 3. Of the 76 randomized to control, 66 were retained to month 3.

Posttraumatic stress symptoms measured with the PTSD Checklist for DSM-5

Outcome measures

Outcome measures
Measure	Widowed Elders' Lifestyle After Loss (WELL) n=58 Participants 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).	Enhanced Usual Care n=66 Participants Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Change From Baseline in Posttraumatic Stress Symptom Burden at 3 Months	9.5 score on a scale Standard Deviation 9.0	10.2 score on a scale Standard Deviation 8.3

Adverse Events

Widowed Elders' Lifestyle After Loss (WELL)

Serious events: 4 serious events

Other events: 34 other events

Deaths: 0 deaths

Enhanced Usual Care

Serious events: 4 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Widowed Elders' Lifestyle After Loss (WELL) n=75 participants at risk 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.	Enhanced Usual Care n=76 participants at risk Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Reproductive system and breast disorders Cancer	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Infections and infestations Respiratory illness	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Cardiac disorders Personal injury	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Cardiac disorders Myocardial infarction	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Gastrointestinal disorders Hernia	1.3% 1/75 • Number of events 1 • from enrollment until end of intervention, up to 3 months.	0.00% 0/76 • from enrollment until end of intervention, up to 3 months.
Infections and infestations Urinary tract infection	1.3% 1/75 • Number of events 1 • from enrollment until end of intervention, up to 3 months.	0.00% 0/76 • from enrollment until end of intervention, up to 3 months.
Surgical and medical procedures Surgery	2.7% 2/75 • Number of events 2 • from enrollment until end of intervention, up to 3 months.	0.00% 0/76 • from enrollment until end of intervention, up to 3 months.

Other adverse events

Additional Information

Sarah T. Stahl, PhD

University of Pittsburgh

Phone: 4122466003

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Widowed Elders' Lifestyle After Loss (WELL) n=75 participants at risk 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.	Enhanced Usual Care n=76 participants at risk Health education, referral for mental health and grief support, and telephone delivered support (weekly) for 3 months
Endocrine disorders Hyperglycemia	2.7% 2/75 • Number of events 2 • from enrollment until end of intervention, up to 3 months.	0.00% 0/76 • from enrollment until end of intervention, up to 3 months.
Blood and lymphatic system disorders Cancer	1.3% 1/75 • Number of events 1 • from enrollment until end of intervention, up to 3 months.	0.00% 0/76 • from enrollment until end of intervention, up to 3 months.
Immune system disorders Lupus	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Cardiac disorders Cardiovascular problems	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Surgical and medical procedures Surgery	4.0% 3/75 • Number of events 3 • from enrollment until end of intervention, up to 3 months.	6.6% 5/76 • Number of events 5 • from enrollment until end of intervention, up to 3 months.
Psychiatric disorders Suicidal ideation	10.7% 8/75 • Number of events 11 • from enrollment until end of intervention, up to 3 months.	13.2% 10/76 • Number of events 14 • from enrollment until end of intervention, up to 3 months.
Psychiatric disorders Mood/anxiety disorder	8.0% 6/75 • Number of events 7 • from enrollment until end of intervention, up to 3 months.	5.3% 4/76 • Number of events 6 • from enrollment until end of intervention, up to 3 months.
General disorders Personal injury	6.7% 5/75 • Number of events 5 • from enrollment until end of intervention, up to 3 months.	7.9% 6/76 • Number of events 6 • from enrollment until end of intervention, up to 3 months.
Psychiatric disorders Alcohol use disorders	9.3% 7/75 • Number of events 7 • from enrollment until end of intervention, up to 3 months.	7.9% 6/76 • Number of events 6 • from enrollment until end of intervention, up to 3 months.
Musculoskeletal and connective tissue disorders Arthritis and/or Pain	9.3% 7/75 • Number of events 9 • from enrollment until end of intervention, up to 3 months.	6.6% 5/76 • Number of events 5 • from enrollment until end of intervention, up to 3 months.
Infections and infestations Infections	6.7% 5/75 • Number of events 5 • from enrollment until end of intervention, up to 3 months.	13.2% 10/76 • Number of events 12 • from enrollment until end of intervention, up to 3 months.
Renal and urinary disorders Bladder Infection	0.00% 0/75 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.
Nervous system disorders Nervous system disorders	4.0% 3/75 • Number of events 3 • from enrollment until end of intervention, up to 3 months.	5.3% 4/76 • Number of events 4 • from enrollment until end of intervention, up to 3 months.
Gastrointestinal disorders Gastrointestinal problems	1.3% 1/75 • Number of events 1 • from enrollment until end of intervention, up to 3 months.	6.6% 5/76 • Number of events 5 • from enrollment until end of intervention, up to 3 months.
General disorders Fatigue	1.3% 1/75 • Number of events 1 • from enrollment until end of intervention, up to 3 months.	1.3% 1/76 • Number of events 1 • from enrollment until end of intervention, up to 3 months.