WIdowed Elders' LIfestyle after Loss (WELL) for Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UPMC: WPIC- Bellefield Towers, Pittsburgh, PA
Depression+1 More
WIdowed Elders' LIfestyle after Loss (WELL) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a digital monitoring system may help improve sleep and circadian rhythms for individuals who have recently lost a spouse.

See full description

Eligible Conditions

  • Depression

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether WIdowed Elders' LIfestyle after Loss (WELL) will improve 1 primary outcome and 1 secondary outcome in patients with Depression. Measurement will happen over the course of baseline vs. 3 months.

baseline vs. 3 months
Change from baseline in depression symptom burden at 3 months
Change from baseline in the rest-activity rhythm at 3 months

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Enhanced Usual Care
1 of 2
Widowed Elders' Lifestyle after Loss (WELL)
1 of 2
Active Control
Experimental Treatment

This trial requires 250 total participants across 2 different treatment groups

This trial involves 2 different treatments. WIdowed Elders' LIfestyle After Loss (WELL) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Widowed Elders' Lifestyle after Loss (WELL)
Behavioral
digital monitoring of sleep, meals, physical activity; motivational health coaching; personalized feedback
Enhanced Usual Care
Other
enhanced usual care

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline vs. 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline vs. 3 months for reporting.

Who is running the study

Principal Investigator
S. T. S.
Prof. Sarah T. Stahl, PhD
University of Pittsburgh

Closest Location

UPMC: WPIC- Bellefield Towers - Pittsburgh, PA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
aged 60 years and older;
spousally (or partner) bereaved within 6 months post-loss or 12 months if 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 >/= 9), together with absence of current MDD, generalized anxiety disorder, post-traumatic stress disorder, or persistent complex bereavement disorder

Patient Q&A Section

Can depression be cured?

"Depressed individuals can get better, but there is a high risk of relapse at some points. Even when they are treatment-successful, the depression may not be completely gone forever. As the disease has a considerable impact on quality of life, treatment should be pursued even when it is clear that there is the risk of relapse." - Anonymous Online Contributor

Unverified Answer

What are the signs of depression?

"When asked about symptoms of depression, patients usually describe a general state of malaise or fatigue, but often the term 'depression' is substituted. Also people with depression often experience thoughts of suicide. It is not surprising then that other psychiatric problems are highly prevalent among those with depression, such as anxiety, anger, irritability and restlessness. Anxiety is the most common co–morbid condition – as is substance abuse.\n\nWhat are the signs of asthma?\n\nA person suffering from asthma may feel short of breath as a result of asthma. They might experience coughing or feel their chest tightening or contracting as they try to breathe." - Anonymous Online Contributor

Unverified Answer

What are common treatments for depression?

"In a recent study, findings provide a basic overview of the types of treatments that are used to treat major depression, such as antidepressants, psychotherapy, and cognitive behavioral therapy, and that have been researched in detail." - Anonymous Online Contributor

Unverified Answer

What causes depression?

"The pathophysiology of depression is a complex set of interwoven processes, including the peripheral nervous system and the central nervous system. Neuroimaging studies have revealed that depression is associated with abnormalities in glucose metabolism. This reflects the fact that many neurotransmitters are disrupted in the nervous system of depressed patients. In the case of brain structures of the CNS, there is evidence for changes in synaptic plasticity or function or for reductions in grey matter volumes. There were also findings in favour of reductions in white matter microstructure, in terms of changes in diffusion or connectivity. The present findings support the conclusion that the pathophysiology of depression may be multi-faceted." - Anonymous Online Contributor

Unverified Answer

How many people get depression a year in the United States?

"As one in six Americans, over one-third of the population, are likely to suffer from a mood abnormality at some point in their life, and nearly half of these are likely to have a disabling form. We are witnessing unprecedented levels of mental illness and disability in the United States. This is due in large part to a combination of societal and environmental factors. We urge urgent concerted action (to address the many contributing factors) across all levels of government (national, state and local) and in the health system." - Anonymous Online Contributor

Unverified Answer

What is depression?

"Depression is the most common psychiatric disorder, with major depressive disorder occurring in about one-third of elderly persons. Depression is more common at younger ages, and in women. The disease is highly prevalent and disabling, and is largely treatable in elderly patients." - Anonymous Online Contributor

Unverified Answer

What does widowed elders' lifestyle after loss (well) usually treat?

"The widowed elders' lifestyle after loss (Well) treats the most basic of essential needs, especially concerning the psychological one. The widowed elders' lifestyle after loss (Well) also promotes a healthy adjustment to the new role of being widowed." - Anonymous Online Contributor

Unverified Answer

Does depression run in families?

"Data from a recent study of the current study provide insight that familial depression may be associated with a higher prevalence of early-onset depression and poorer treatment outcomes. The impact of depression on family caregivers warrants urgent investigation and the need for support and interventions to help parents gain greater insight toward their child's experiences." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving widowed elders' lifestyle after loss (well)?

"The loss of a spouse presents a difficult clinical decision. Elderly widowers and widows presenting to a geriatrician require careful discussion on their options. More research is warranted before they should be advised to stop their routine medications for one to two years." - Anonymous Online Contributor

Unverified Answer

What is the latest research for depression?

"Depression is prevalent in medical emergency admission. The prevalence of depression in emergency admissions may partly be a consequence of physicians who perceive depression to be an under recognized symptom of medical illness." - Anonymous Online Contributor

Unverified Answer

How serious can depression be?

"Depression is a illness as serious and alarming as, say, tuberculosis and can be a debilitating illness where a person loses the will to work or a relationship with their loved ones." - Anonymous Online Contributor

Unverified Answer

Does widowed elders' lifestyle after loss (well) improve quality of life for those with depression?

"Elderly widowers' lifestyle after loss may be beneficial to those with concurrent depression. They had a higher quality of life than those without depression, although quality of life was worse in older widowers question: Does pre-operative fasting reduce nausea and vomiting after elective gastric bypass? answer: Pre-operative fasting had no effect on the incidence of postoperative vomiting after bariatric surgery. Routine use of fasting before major abdominal surgery may be omitted." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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