Promoting Widowed Elders Lifestyle After Loss

University of Pittsburgh

Status: Completed

Conditions: Grief; Bereavement; Health Behavior; Depression; Anxiety; Mood Disorders

Treatments: Behavioral: Behavioral self-monitoring; Behavioral: Behavioral self-monitoring + Motivational interviewing

Study type: Interventional

Funder types: Other

Identifiers

NCT02631291

PRO14110233

Details and patient eligibility

About

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.

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

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

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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57 participants in 3 patient groups

Lifestyle

Experimental group

Description:

Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet.

Treatment:

Behavioral: Behavioral self-monitoring

Usual Care

No Intervention group

Description:

Participants randomized to this condition will receive the written education provided to all participants.

LIfestyle + coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral self-monitoring + Motivational interviewing