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WELL Behavioral Probe for Suicide (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and at month 1, 2, 3, 6, 9, and 12.

Awards & highlights

RISE Trial 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.Check my eligibility

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.See study design

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.

RISE Trial 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.

RISE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and at month 1, 2, 3, 6, 9, and 12.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Interdaily stability of the rest-activity rhythm

RISE Trial Design

1Treatment groups

Experimental Treatment

Group I: WELL Behavioral ProbeExperimental Treatment1 Intervention

Digital monitoring of sleep, meals, and social activity, for 3 months.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,530 Total Patients Enrolled

112 Trials studying Suicide

1,156,650 Patients Enrolled for Suicide

University of PittsburghLead Sponsor

1,723 Previous Clinical Trials

16,342,787 Total Patients Enrolled

7 Trials studying Suicide

2,559 Patients Enrolled for Suicide

Sarah Stahl, PhDPrincipal InvestigatorUniversity of Pittsburgh

1 Previous Clinical Trials

57 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"Indeed, as per the details provided on clinicaltrials.gov, this trial is currently in search of eligible participants. The initial posting date for this study was November 20th, 2023, and it received its most recent update on January 3rd, 2024."

Answered by AI

What is the upper limit for the total number of participants involved in this clinical study?

"Indeed, the information on clinicaltrials.gov verifies that this medical trial is currently seeking eligible individuals. The trial was initially published on November 20th, 2023 and last modified on January 3rd, 2024. Researchers aim to recruit a total of 169 participants from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

Sarah T. Stahl, PhD 2023. "Risk and Resilience to Suicide Following Late-Life Spousal Bereavement". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191484.

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