Promoting Widowed Elders Lifestyle After Loss

NCT02631291 | Completed DMC

• 1 other identifier: PRO14110233
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms (Hamilton Rating Scale of Depression [HRSD])

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

  12 months

Secondary Outcomes (2)

• Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7])

  12 months

• Grief symptoms (Inventory of Complicated Grief [ICG])

  12 months

Study Arms (3)

Lifestyle

EXPERIMENTAL

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

Behavioral: Behavioral self-monitoring

Usual Care

NO INTERVENTION

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

LIfestyle + coaching

EXPERIMENTAL

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

Interventions

Behavioral self-monitoring BEHAVIORAL

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.

Lifestyle

Behavioral self-monitoring + Motivational interviewing BEHAVIORAL

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.

LIfestyle + coaching

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Sarah Stahl

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Stahl ST, Croswell E, Patel K, Neagoe I, Minhaj S, Lopaczynski A, Lyew T. Long-term follow-up of clinical trial participants: Predictors of post-trial response in older subjects. Contemp Clin Trials. 2024 Aug;143:107579. doi: 10.1016/j.cct.2024.107579. Epub 2024 May 22.

  PMID: 38789080 DERIVED

MeSH Terms

Conditions

Mood Disorders; Depression; Anxiety Disorders; Health Behavior

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Sarah Stahl, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 16, 2015
• Study Start: November 1, 2015
• Primary Completion: May 17, 2019
• Study Completion: May 17, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)