Promoting Widowed Elders Lifestyle After Loss



Status:Recruiting
Conditions:Anxiety, Anxiety, Depression, Healthy Studies, Psychiatric
Therapuetic Areas:Psychiatry / Psychology, Other
Healthy:No
Age Range:60 - Any
Updated:3/8/2019
Start Date:November 2015
End Date:January 31, 2020
Contact:Sarah T Stahl, PhD
Email:sts80@pitt.edu
Phone:412-246-6003

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

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.

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.

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;
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Phone: 412-246-6003
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Pittsburgh, PA
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