Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Pittsburgh
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
WELL Behavioral Probe
BehavioralParticipant 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.
Treatment groups
169 Participants
are divided into 1 treatment groupGroup A: WELL Behavioral ProbeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and at month 1, 2, 3, 6, 9, and 12.2
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.
Time frame
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.
Time frame
Baseline and at month 1, 2, 3, 6, 9, and 12.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pittsburgh
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov