SuicideRISENCT06191484
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
A study testing WELL Behavioral Probe in people with Suicide and Bereavement, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Suicide, Bereavement
- What is being tested?
- WELL Behavioral Probe
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 1 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bereaved < or = to 12 months from spousal/partner loss (+ 4 weeks)
- > or = to 60 years old
- Current major depressive episode (w/o psychotic features) as established by the MINI diagnostic interview. A) Subsyndromal or syndromal depression (> 9 HDRS) B) Current major depressive episode (w/o psychotic features) as established by the MINI diagnostic interview. C) History of depression severe enough to trigger treatment (e.g., antidepressant, counselling). D) Verified history of unipolar or bipolar major depressive disorder (MDD)*,
- Please note, we will include those with a life-time history of Manic or Hypomanic episode as established by the MINI diagnostic interview), if they are currently in a depressive episode.
- Even if there is no indication of depression (see A-D above), we include those who have A) history of suicide attempt
- or currently have significant suicidal ideation (Scale of Suicidal Ideation score >4)
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- Does not reside in nursing home
- Not a current shift worker
- No major cognitive impairment: TICS score of > or = to 27
Who cannot join
- Bereaved >12 months (+ 4 weeks) from spousal/partner bereavement
- < 60 years old
- Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
- Diagnosis of schizophrenia/schizoaffective disorders
- Current and/or lifetime history of psychosis (or medications listed indicate diagnosis of these disorders)
- Current Manic or Hypomanic Episode (note past history of Manic or Hypomanic episodes are not exclusion)
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- 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)
- Resides outside of PA, WV or OH
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Stahl, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh (UPMC)
Pittsburgh, Pennsylvania, 15212
Emilee Croswell, 412-440-8418, RISE_research@pitt.edu
Sarah Stahl, sts80@pitt.edu
About this study
Official title: Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity
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.
Read the detailed description
Experiencing the death of a spouse or life partner is a profoundly distressing event that may cause abrupt changes in one's daily routine, including decreased self-care and withdrawal from social activities. While most individuals adapt over time, a substantial number of older bereaved spouses (20-35%) experience depression, loneliness, suicidal thoughts, and early mortality, including death by suicide.
The objective of this study is to examine the risk for and resilience to late life suicide during the early spousal bereavement period by investigating the extent to which (1) social connectedness influences suicide risk and (2) whether circadian rhythm instability (inconsistent patterns of sleep, activity, meals, and socialization) helps explain this association.
The investigators will enroll 169 adults aged 60+ years who experienced the death of a spouse or life partner within the previous 12 months. All participants will complete repeated assessments of social connectedness, clinical assessments of depression and suicide ideation, and accelerometry recordings of the 24-hour pattern of sleep and activity. Participants will also complete a 3-month behavioral probe, designed to promote self-care behaviors in older bereaved spouses using technology and motivational health coaching. The behavioral probe targets circadian rhythm stability by focusing on regular routine of sleep, meals, and social activities. The behavioral probe will determine whether modifying social connectedness reduces suicide risk and whether circadian rhythm stability explains part of this association.
- Conditions
- Suicide, Bereavement
- Being tested
- WELL Behavioral Probe
- Keywords
- grief, bereavement, suicide, geriatric, health, technology, depression
- Medical subject headings
- Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WELL Behavioral ProbeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| WELL Behavioral Probe | Experimental | Digital monitoring of sleep, meals, and social activity, for 3 months. Receives: Behavioral: WELL Behavioral Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and at month 1, 2, 3, 6, 9, and 12.
Secondary outcomes (1)
Interdaily stability of the rest-activity rhythm
Measured using 1-week of accelerometry recordings.
Measured: Baseline and at month 1, 2, 3, 6, 9, and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start20 Nov 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sarah T. Stahl, PhD, University of Pittsburgh
- Investigators
- Sarah Stahl, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191484
- Sponsor's protocol ID
- STUDY23060037
- Other IDs
- R01MH132114
- Acronym
- RISE
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stahl ST, Franzen P, Gujral S, Szanto K. Protocol for a Digital Health Intervention to Improve Behavioral Rhythms and Social Connectedness for Reducing Suicide Risk Among Older Bereaved Marital Partners. Biopsychosoc Sci Med. 2026 Sep 22. doi: 10.1097/PSY.0000000000001532. Online ahead of print.
PubMed 42771861
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity
- ClinicalTrials.gov ID
- NCT06191484
- Acronym / sponsor ID
- RISE / STUDY23060037
- Conditions
- Suicide, Bereavement
- Keywords
- grief, bereavement, suicide, geriatric, health, technology, depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 169 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Experiencing the death of a spouse or life partner is a profoundly distressing event that may cause abrupt changes in one's daily routine, including decreased self-care and withdrawal from social activities. While most individuals adapt over time, a substantial number of older bereaved spouses (20-35%) experience depression, loneliness, suicidal thoughts, and early mortality, including death by suicide.
The objective of this study is to examine the risk for and resilience to late life suicide during the early spousal bereavement period by investigating the extent to which (1) social connectedness influences suicide risk and (2) whether circadian rhythm instability (inconsistent patterns of sleep, activity, meals, and socialization) helps explain this association.
The investigators will enroll 169 adults aged 60+ years who experienced the death of a spouse or life partner within the previous 12 months. All participants will complete repeated assessments of social connectedness, clinical assessments of depression and suicide ideation, and accelerometry recordings of the 24-hour pattern of sleep and activity. Participants will also complete a 3-month behavioral probe, designed to promote self-care behaviors in older bereaved spouses using technology and motivational health coaching. The behavioral probe targets circadian rhythm stability by focusing on regular routine of sleep, meals, and social activities. The behavioral probe will determine whether modifying social connectedness reduces suicide risk and whether circadian rhythm stability explains part of this association.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WELL Behavioral Probe | Experimental | Behavioral: WELL Behavioral ProbeDigital monitoring of sleep, meals, and social activity, for 3 months. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Bereaved < or = to 12 months from spousal/partner loss (+ 4 weeks)
- > or = to 60 years old
- Current major depressive episode (w/o psychotic features) as established by the MINI diagnostic interview. A) Subsyndromal or syndromal depression (> 9 HDRS) B) Current major depressive episode (w/o psychotic features) as established by the MINI diagnostic interview. C) History of depression severe enough to trigger treatment (e.g., antidepressant, counselling). D) Verified history of unipolar or bipolar major depressive disorder (MDD)*,
- Please note, we will include those with a life-time history of Manic or Hypomanic episode as established by the MINI diagnostic interview), if they are currently in a depressive episode.
- Even if there is no indication of depression (see A-D above), we include those who have A) history of suicide attempt
Key exclusion criteria (11 listed)
- Bereaved >12 months (+ 4 weeks) from spousal/partner bereavement
- < 60 years old
- Patient is not spousal/partner bereaved (ex: parent, sibling, etc.)
- Diagnosis of schizophrenia/schizoaffective disorders
- Current and/or lifetime history of psychosis (or medications listed indicate diagnosis of these disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WELL Behavioral ProbeParticipant 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. | Behavioural | WELL Behavioral Probe |
Primary outcome
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.
1 secondary outcome
Interdaily stability of the rest-activity rhythm
Time frame: Baseline and at month 1, 2, 3, 6, 9, and 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Derived from this study: PubMed 42771861Stahl ST, Franzen P, Gujral S, Szanto K. Protocol for a Digital Health Intervention to Improve Behavioral Rhythms and Social Connectedness for Reducing Suicide Risk Among Older Bereaved Marital Partners. Biopsychosoc Sci Med. 2026 Sep 22. doi: 10.1097/PSY.0000000000001532. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Stahl, PhD contact
Sarah Stahl, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WELL Behavioral Probe in people with Suicide and Bereavement, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilee Croswell, BA (4124408418, croswellej@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06191484, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.