NCT06191484 · University of Pittsburgh
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
(RISE)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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 measures
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.
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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)
Where
- Pittsburgh, Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 12, 2025 · Source of record for eligibility and locations