Promoting Widowed Elders Lifestyle After Loss

Not Applicable

Completed

• Conditions: Anxiety; Depression; Grief; Bereavement; Health Behavior; Mood Disorders
• Interventions: Behavioral: Behavioral self-monitoring; Behavioral: Behavioral self-monitoring + Motivational interviewing

• Registration Number: NCT02631291
• Lead Sponsor: University of Pittsburgh

Brief Summary

This study is for adults 60 years and older who are grieving the recent loss of a spouse or partner. Bereavement is one of the most distressing transitions faced by older adults and triggers dramatic changes to older adults' daily routine which puts them at-risk for a mood disorder. The purpose of this study is to promote bereaved elders' mental health by focusing on healthy lifestyle practices. Study treatment involves using a tablet to record their daily physical activity, diet, and sleep behaviors, for 12 weeks. The investigators follow-up with people for up to one year.

Detailed Description

Preventing mental health problems that develop following spousal bereavement is important because these conditions are highly prevalent and have lasting adverse consequences for the well-being of the bereaved survivor. The proposed research will evaluate the feasibility and acceptability of a healthy lifestyle intervention that uses a technology-based behavioral self-monitoring protocol to encourage engagement in physical activity, healthy eating, and good sleep practices following spousal bereavement. Data from 10 participants will be used for the development of a prevention intervention manual (Aim 1). A small pilot study will be conducted (Aim 2) in which 50 participants will be randomly assigned to 12 weeks of (1) behavioral self-monitoring using a smartphone (n=20), (2) behavioral self-monitoring using a smartphone + motivational interviewing-based lifestyle coaching (n=20), or (3) enhanced usual care (n=10). Blood samples will be collected to explore inflammatory cytokines as a potential mediator/moderator of mental health risk.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-12-07
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-16
• Primary Completion: 2019-05-17
• Study Completion: 2019-05-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• 60 years and older
• experiencing the recent death (within 8 months) of a spouse or partner
• at-risk for developing mental health problems, based on high-risk markers defined as: subthreshold symptoms of depression (Hamilton Depression Rating Scale [HAM-D]101 of 9-14), anxiety (Generalized Anxiety Disorder Scale [GAD-7] ≥ 10, and/or complicated grief (Inventory of Complicated Grief [ICG] of 20-29), together with absence of current major depression, generalized anxiety, post-traumatic stress, or suicidiality; or high medical comorbidity (2 or more systems on the CIRS-G), low social support (Perceived Isolation Scale below zero), functional disability (limitation with at least 1 ADL/IADL),or

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Exclusion Criteria

• current DSM-V criteria for syndromal mood, psychosis, anxiety, eating disorder, or substance abuse dependence;
• dementia; 3MS<80;
• patients taking psychotropic medications to stabilize mental health problems including antidepressants and benzodiazepines;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Lifestyle	Behavioral self-monitoring	Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet.
LIfestyle + coaching	Behavioral self-monitoring + Motivational interviewing	Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet; and behavioral self-monitoring + motivational interviewing lifestyle coaching.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms (Hamilton Rating Scale of Depression [HRSD])	12 months	Symptom levels of depression (Hamilton Rating Scale of Depression \[HRSD\]),

Secondary Outcome Measures

Name	Time	Method
Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])	12 months	Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale \[GAD-7\])
Grief symptoms (Inventory of Complicated Grief [ICG])	12 months	Symptom levels of complicated grief (Inventory of Complicated Grief \[ICG\])

Trial Locations

Locations (1)

Sarah Stahl; 🇺🇸 Pittsburgh, Pennsylvania, United States