Promoting Widowed Elders Lifestyle After Loss

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631291
• Other study ID #: PRO14110233
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: May 17, 2019

Study information

• Verified date: March 2020
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 17, 2019
• Est. primary completion date: May 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Anxiety
• Bereavement
• Depression
• Grief
• Health Behavior
• Mood Disorders

Intervention

Behavioral:
• Behavioral self-monitoring
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.
• Behavioral self-monitoring + Motivational interviewing
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.

Locations

Country	Name	City	State
United States	Sarah Stahl	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms (Hamilton Rating Scale of Depression [HRSD])	Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]),	12 months
Secondary	Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])	Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7])	12 months
Secondary	Grief symptoms (Inventory of Complicated Grief [ICG])	Symptom levels of complicated grief (Inventory of Complicated Grief [ICG])	12 months