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NCT Number: NCT06191484

Risk and Resilience to Suicide Following Late-Life Spousal Bereavement

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh (UPMC)

Pittsburgh, Pennsylvania, 15212, United States

Location status: Recruiting

Location contact

Emilee Croswell

CONTACT

[email protected]

412-440-8418

Sarah Stahl

CONTACT

[email protected]

Sarah Stahl, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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)

Treatment and study plan

WELL Behavioral Probe

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Interdaily stability of the rest-activity rhythm

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

    Measured using 1-week of accelerometry recordings.

Study contacts

Contact information is provided by the study sponsor or research team.

Emilee Croswell, BA

CONTACT

[email protected]

4124408418

Sarah Stahl, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Risk and Resilience to Late-life Suicidal Ideation and Behavior After Spousal Bereavement: Targeting Social Connectedness to Strengthen Circadian Rhythmicity

Acronym: RISE

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Jan 5, 2024
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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