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Behavioral Probe for Grief and Suicide Risk (RISE Trial)

N/A
Recruiting
Led By Sarah Stahl, PhD
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bereaved ≤ 12 months from spousal/partner loss
≥ 65 years old
Must not have
Prior diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis or medications listed indicate diagnosis of these disorders/MDD or MDE with psychotic features
Unstable medical condition (e.g., unstable angina, end stage renal disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and at month 1, 2, 3, 6, 9, and 12.
Awards & highlights
No Placebo-Only Group

Summary

This trial is called the RISE study and it aims to understand how the sleep patterns and social activities of older adults who have recently lost their spouse or life partner are related to their mood and thoughts of

Who is the study for?
This trial is for people aged 65 or older who have lost a spouse or life partner within the last year. They must have a history of suicide attempts, major depression without psychosis, or be currently experiencing significant depressive symptoms. Individuals with schizophrenia, bipolar disorder, current psychosis, cognitive impairment, or those living in nursing homes are not eligible.
What is being tested?
The RISE study is testing how sleep and social activity patterns over a full day affect mood and thoughts of suicide in older adults grieving the recent loss of their spouse. The WELL Behavioral Probe will be used to monitor these rhythms.
What are the potential side effects?
Since this study involves monitoring behavior rather than medication intervention, traditional side effects are not applicable. However, participants may experience emotional distress due to discussions about grief and suicidal thoughts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I lost my spouse or partner less than a year ago.
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I am 65 years old or older.
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I have never been diagnosed with schizophrenia, schizoaffective disorders, bipolar disorder, or current psychosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or have had psychosis.
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I do not have any unstable health conditions like severe heart or kidney problems.
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I am younger than 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and at month 1, 2, 3, 6, 9, and 12.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and at month 1, 2, 3, 6, 9, and 12. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in perceived loneliness over 12 months using the UCLA Loneliness Scale
Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)
Secondary study objectives
Interdaily stability of the rest-activity rhythm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: WELL Behavioral ProbeExperimental Treatment1 Intervention
Digital monitoring of sleep, meals, and social activity, for 3 months.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,740,003 Total Patients Enrolled
University of PittsburghLead Sponsor
1,789 Previous Clinical Trials
16,359,454 Total Patients Enrolled
Sarah Stahl, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
57 Total Patients Enrolled
~113 spots leftby Dec 2028
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