Promoting Widowed Elders Lifestyle After Loss
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Depressive symptoms (Hamilton Rating Scale of Depression [HRSD]) [12 months]
Symptom levels of depression (Hamilton Rating Scale of Depression [HRSD]),
Secondary Outcome Measures
- Anxiety symptoms (7-item Generalized Anxiety Disorder Scale [GAD-7]) [12 months]
Symptom levels of anxiety (7-item Generalized Anxiety Disorder Scale [GAD-7])
- Grief symptoms (Inventory of Complicated Grief [ICG]) [12 months]
Symptom levels of complicated grief (Inventory of Complicated Grief [ICG])
Eligibility Criteria
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;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sarah Stahl | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- University of Pittsburgh
Investigators
- Principal Investigator: Sarah Stahl, PhD, University of Pittsburgh
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PRO14110233