NCT06191484

Brief Summary

The purpose of the RISE study is to examine how the 24-hour rhythm of sleep and social activity relate to mood and suicidal ideation among older adults that recently lost a spouse or life partner.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
43mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Nov 2023Dec 2029

Study Start

First participant enrolled

November 20, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

November 12, 2025

Status Verified

November 1, 2025

Enrollment Period

5.1 years

First QC Date

December 19, 2023

Last Update Submit

November 7, 2025

Conditions

SuicideBereavement

Keywords

griefbereavementsuicidegeriatrichealthtechnologydepression

Outcome Measures

Primary Outcomes (2)

  • Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI)

    The BSSI is one of the most commonly used clinician-administered scales to assess presence and severity of suicidality. The total BSS score can range from 0 to 38, with higher values indicating a greater risk of suicide.

    Baseline and at month 1, 2, 3, 6, 9, and 12.

  • Change in perceived loneliness over 12 months using the UCLA Loneliness Scale

    The UCLA Loneliness Scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation. The total score ranges from 20 to 80. Higher scores indicate higher loneliness.

    Baseline and at month 1, 2, 3, 6, 9, and 12.

Secondary Outcomes (1)

  • Interdaily stability of the rest-activity rhythm

    Baseline and at month 1, 2, 3, 6, 9, and 12.

Study Arms (1)

WELL Behavioral Probe

EXPERIMENTAL

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

Behavioral: WELL Behavioral Probe

Interventions

WELL Behavioral ProbeBEHAVIORAL

Participant record the timing and regularity of sleep, meals, and social activity twice daily, for 3 months, using a digital diary. Participants also receive weekly motivational health coaching.

WELL Behavioral Probe

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Bereaved \< or = to 12 months from spousal/partner loss
  • \> or = to 65 years old
  • Verified history of suicide attempt/attempts and/or current or past history of Major Depressive Disorder/Major Depressive Episode (MDD/MDE) (without psychotic features), or history of depression severe enough to trigger treatment, or current subsyndromal depression (\> or = to 9 HDRS)
  • No diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis
  • Does not reside in nursing home
  • Not a current shift worker
  • No major cognitive impairment: TICS score of \> or = to 27

You may not qualify if:

  • Bereaved \>12 months from spousal/partner bereavement
  • \< 65 years old
  • Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
  • Prior diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis or medications listed indicate diagnosis of these disorders/MDD or MDE with psychotic features
  • Major cognitive impairment: TICS score of \<27
  • Current shift worker
  • Resides in a nursing home
  • Unstable medical condition (e.g., unstable angina, end stage renal disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh (UPMC)

Pittsburgh, Pennsylvania, 15212, United States

RECRUITING

MeSH Terms

Conditions

SuicideDepression

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Sarah Stahl, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilee Croswell, BA

CONTACT

4124408418croswellej@upmc.edu

Sarah Stahl, PhD

CONTACT

sts80@pitt.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Assistant Professor of Clinical and Translational Science

Study Record Dates

First Submitted

December 19, 2023

First Posted

January 5, 2024

Study Start

November 20, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 1, 2029

Last Updated

November 12, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)