Clinical trial NCT02631291: Promoting Widowed Elders Lifestyle After Loss
Official title: A Randomized Pilot Study of Behavioral Self-monitoring to Promote Mental Health Among Spousally Bereaved Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Depression
Anxiety
Grief
Bereavement
Health Behavior
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2015-12-16
Enrollment: 57
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Depressive symptoms (Hamilton Rating Scale of Depression [HRSD])
timeFrame: 12 months
Secondary outcomes:
measure: Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])
timeFrame: 12 months
measure: Grief symptoms (Inventory of Complicated Grief [ICG])
timeFrame: 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Sarah Stahl
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sarah Stahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: