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Promoting Widowed Elders Lifestyle After Loss

Primary Purpose

Mood Disorders, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral self-monitoring
Behavioral self-monitoring + Motivational interviewing
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mood Disorders

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts 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;

Sites / Locations

  • Sarah Stahl

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

Lifestyle

Usual Care

LIfestyle + coaching

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

Depressive symptoms (Hamilton Rating Scale of Depression [HRSD])
Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]),

Secondary Outcome Measures

Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])
Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7])
Grief symptoms (Inventory of Complicated Grief [ICG])
Symptom levels of complicated grief (Inventory of Complicated Grief [ICG])

Full Information

First Posted
December 7, 2015
Last Updated
March 26, 2020
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02631291
Brief Title
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
May 17, 2019 (Actual)
Study Completion Date
May 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mood Disorders, Depression, Anxiety, Grief, Bereavement, Health Behavior

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lifestyle
Arm Type
Experimental
Arm Description
Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to this condition will receive the written education provided to all participants.
Arm Title
LIfestyle + coaching
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral self-monitoring
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral self-monitoring + Motivational interviewing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms (Hamilton Rating Scale of Depression [HRSD])
Description
Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]),
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])
Description
Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7])
Time Frame
12 months
Title
Grief symptoms (Inventory of Complicated Grief [ICG])
Description
Symptom levels of complicated grief (Inventory of Complicated Grief [ICG])
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Stahl, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sarah Stahl
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Promoting Widowed Elders Lifestyle After Loss

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