Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT06191484

Conditions

Suicide

Bereavement

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

WELL Behavioral Probe

Study Details

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.

Conditions

Suicide

Bereavement

Study ID

NCT06191484

Start date

Nov 20, 2023

Status verified date

Nov, 2025

Completion date

Dec 1, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Older adults who recently lost their spouse or life partner and are high risk for suicidal thoughts and/or behavior.

Inclusion Criteria:

1. Bereaved < or = to 12 months from spousal/partner loss
2. > or = to 65 years old
3. 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)
4. No diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis
5. Does not reside in nursing home
6. Not a current shift worker
7. No major cognitive impairment: TICS score of > or = to 27

Exclusion Criteria:

1. Bereaved >12 months from spousal/partner bereavement
2. < 65 years old
3. Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
4. Prior diagnosis of schizophrenia/schizoaffective disorders/bipolar/current psychosis or medications listed indicate diagnosis of these disorders/MDD or MDE with psychotic features
5. Major cognitive impairment: TICS score of <27
6. Current shift worker
7. Resides in a nursing home
8. Unstable medical condition (e.g., unstable angina, end stage renal disease)

Study Design

Enrollment

169 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: WELL Behavioral Probe

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

Interventions

WELL Behavioral Probe

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.

Primary outcome measure

  • Change in suicidal ideation over 12 months using the Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: Baseline and at month 1, 2, 3, 6, 9, and 12. ]
  • Change in perceived loneliness over 12 months using the UCLA Loneliness Scale [ Time Frame: Baseline and at month 1, 2, 3, 6, 9, and 12. ]

Central Contacts and Locations

Central contacts

Emilee Croswell, BA

4124408418croswellej@upmc.edu

Sarah Stahl, PhD

sts80@pitt.edu

Locations

University of Pittsburgh (UPMC)

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Emilee Croswell

412-440-8418RISE_research@pitt.edu

Sarah Stahl

sts80@pitt.edu

Principal Investigator:

Sarah Stahl, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • grief
  • bereavement
  • suicide
  • geriatric
  • health
  • technology
  • depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2025-11-12.