Promoting Widowed Elders Lifestyle After Loss

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Pilot Study of Behavioral Self-monitoring to Promote Mental Health Among Spousally Bereaved Older Adults

Conditions
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Mood Disorders, Depression, Anxiety, Grief, Bereavement, Health Behavior

Intervention / Treatment
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* Behavioral: Behavioral self-monitoring
* Behavioral: Behavioral self-monitoring + Motivational interviewing


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle<br>Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet. | Behavioral: Behavioral self-monitoring<br>* Behavioral self-monitoring will teach older adults to pay attention to their daily lifestyle practices and the conditions in which they occur. Behavioral self-monitoring is crucial for detecting change early, thereby preventing complications (mental illness symptom burden) that are associated with disruptions in healthy lifestyle practices. The steps of behavioral self-monitoring include: (1) selecting a goal, (2) paying attention to some aspect of behavior, and (3) recording some details of that behavior in a diary.<br>|
| No Intervention: Usual Care<br>Participants randomized to this condition will receive the written education provided to all participants. | |
| Experimental: LIfestyle + coaching<br>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. | Behavioral: Behavioral self-monitoring + Motivational interviewing<br>* Participants will receive the same Behavioral self-monitoring intervention; participants in this condition will interact with a 'lifestyle coach' about their recorded behaviors, weekly. The lifestyle coach will use motivational interviewing to enhance older adults' confidence and intrinsic motivation to engage in healthy lifestyle practices.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depressive symptoms (Hamilton Rating Scale of Depression [HRSD]) | Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]), | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7]) | Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7]) | 12 months | 
| Grief symptoms (Inventory of Complicated Grief [ICG]) | Symptom levels of complicated grief (Inventory of Complicated Grief [ICG]) | 12 months |