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Promoting Widowed Elders Lifestyle After Loss

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ClinicalTrials.gov Identifier: NCT02631291
Recruitment Status : Recruiting
First Posted : December 16, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Sarah T. Stahl, PhD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Mood Disorders Depression Anxiety Grief Bereavement Health Behavior Behavioral: Behavioral self-monitoring Behavioral: Behavioral self-monitoring + Motivational interviewing Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Pilot Study of Behavioral Self-monitoring to Promote Mental Health Among Spousally Bereaved Older Adults
Study Start Date : November 2015
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: Lifestyle
Behavioral self-monitoring of daily physical activity, dietary, and sleep behaviors, for 12 weeks, into an electronic tablet.
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.

No Intervention: Usual Care
Participants randomized to this condition will receive the written education provided to all participants.
Experimental: LIfestyle + coaching
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
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 Measures :
  1. Depressive symptoms (Hamilton Rating Scale of Depression [HRSD]) [ Time Frame: 12 months ]
    Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]),


Secondary Outcome Measures :
  1. Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7]) [ Time Frame: 12 months ]
    Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7])

  2. Grief symptoms (Inventory of Complicated Grief [ICG]) [ Time Frame: 12 months ]
    Symptom levels of complicated grief (Inventory of Complicated Grief [ICG])



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631291


Contacts
Contact: Sarah T Stahl, PhD 412-246-6003 sts80@pitt.edu

Locations
United States, Pennsylvania
Sarah Stahl Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Sarah Stahl, PhD    412-246-6003    sts80@pitt.edu   
Contact: James Emanuel, BA    412-246-6004    emanuelje@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Sarah Stahl, PhD University of Pittsburgh

Responsible Party: Sarah T. Stahl, PhD, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02631291     History of Changes
Other Study ID Numbers: PRO14110233
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Mood Disorders
Mental Disorders