Behavioral Probe for Grief and Suicide Risk

(RISE Trial)

Overseen By Emilee Croswell, BA

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Schizophrenia, Bipolar, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

169 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how daily patterns in sleep and social activities affect mood and thoughts of self-harm in older adults who recently lost a spouse or partner. Researchers use the WELL Behavioral Probe, a digital tool, to monitor sleep, meals, and social interactions for three months. The study seeks participants aged 65 and older who have lost their spouse or partner within the past year and have a history of depression or suicidal thoughts. As an unphased trial, it offers participants the opportunity to contribute to valuable research that could enhance mental health support for others in similar situations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the WELL Behavioral Probe is safe?

Research shows that the WELL Behavioral Probe uses digital tools to track sleep, meals, and social activities. This method involves no medication or medical procedures, generally making it safer for participants. As a study of behavior, the risk of side effects is much lower than with drug treatments. Previous studies have not reported any negative effects from this type of monitoring. The study aims to understand daily activity patterns, making it easy for participants to handle. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The WELL Behavioral Probe is unique because it digitally monitors sleep, meals, and social activity, offering a holistic approach to understanding grief and suicide risk. Unlike traditional treatments that might focus on therapy or medication, this method provides real-time data on daily habits and lifestyle, potentially allowing for more personalized and timely interventions. Researchers are excited about this approach because it could reveal new insights into behavioral patterns that are linked to grief and suicide risk, leading to more effective prevention strategies.

What evidence suggests that the WELL Behavioral Probe is effective for grief and suicide risk?

Research shows that tracking daily activities such as sleep, meals, and social interactions can help researchers understand mood changes and suicidal thoughts in older adults who have lost a spouse. Studies have indicated that the period immediately following the loss of a loved one is crucial, with an increased risk of mental health issues. In this trial, participants will use the WELL Behavioral Probe, which employs digital tools to monitor these daily habits over three months, aiming to identify risks early. Although specific evidence on this exact method's effectiveness is limited, tracking behaviors has generally proven helpful in spotting risks and improving support in similar situations. ^{1 3 6 7 8}

Who Is on the Research Team?

Sarah Stahl, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for people aged 65 or older who have lost a spouse or life partner within the last year. They must have a history of suicide attempts, major depression without psychosis, or be currently experiencing significant depressive symptoms. Individuals with schizophrenia, bipolar disorder, current psychosis, cognitive impairment, or those living in nursing homes are not eligible.

Inclusion Criteria

No major cognitive impairment: TICS score of ≥ 27

I lost my spouse or partner less than a year ago.

I am 65 years old or older.

Exclusion Criteria

I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or have had psychosis.

Current shift worker

Resides in a nursing home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Behavioral Probe

Participants complete a 3-month behavioral probe designed to promote self-care behaviors using technology and motivational health coaching, focusing on regular routines of sleep, meals, and social activities.

12 weeks

Monthly assessments

Follow-up

Participants are monitored for changes in perceived loneliness and suicidal ideation over 12 months using the UCLA Loneliness Scale and Beck Scale for Suicidal Ideation.

12 months

Assessments at month 1, 2, 3, 6, 9, and 12

What Are the Treatments Tested in This Trial?

Interventions

• WELL Behavioral Probe

Trial Overview

The RISE study is testing how sleep and social activity patterns over a full day affect mood and thoughts of suicide in older adults grieving the recent loss of their spouse. The WELL Behavioral Probe will be used to monitor these rhythms.

How Is the Trial Designed?

Group I: WELL Behavioral Probe Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

This clinical trial will evaluate the effectiveness of an updated version of Problem Solving Therapy (emotion-centered PST) combined with enhanced usual care (EUC) in reducing suicidal ideation among 150 older Veterans with active suicidal thoughts, compared to EUC alone.

The study aims to assess changes in suicidal ideation and reasons for living over multiple time points, providing insights into how effective EC-PST is in improving coping skills and potentially informing future clinical guidelines for suicide prevention in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond maintaining safety: Examining the benefit of emotion-centered problem solving therapy added to safety planning for reducing late life suicide risk. Beaudreau, SA., Lutz, J., Wetherell, JL., et al.[2023]

The study analyzed responses from 49 patients regarding helpful aspects of their treatment for suicidal risk, leading to the development of a reliable coding system to identify major themes in their experiences.

Insights gained from 52 patients on what they learned from their clinical care can inform future suicide-specific treatments, highlighting the importance of patient feedback in improving therapeutic approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Suicidal Risk. Schembari, BC., Jobes, DA., Horgan, RJ.[2022]

In a study of 130 elderly individuals who lost their spouses, those with high levels of complicated grief were significantly more likely to experience suicidal ideation, with 57% of high grief patients reporting such thoughts compared to only 24% of those with low grief.

The findings suggest that high levels of complicated grief and depression can increase vulnerability to suicidal thoughts, indicating that clinicians should monitor grief symptoms closely to identify patients at risk for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suicidal ideation in elderly bereaved: the role of complicated grief. Szanto, K., Prigerson, H., Houck, P., et al.[2007]

A clinical trial comparing behavior therapy to insight-oriented therapy for repeated suicide attempters showed that behavior therapy was more effective in reducing depression, anxiety, and suicidal ideation over a nine-month follow-up period.

The success of the behavior therapy package was attributed to its structured approach and assertive follow-up, which likely enhanced patient outcomes during the ten-day inpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavior therapy vs insight-oriented therapy for repeated suicide attempters. Liberman, RP., Eckman, T.[2019]

Current clinical trials for behavioral health interventions often do not monitor adverse events as thoroughly as those for medications and medical devices, focusing mainly on serious incidents like suicide attempts and hospitalizations.

There is a need for expanded monitoring of adverse events in psychotherapy trials to better inform patients about potential risks, including temporary increases in anxiety, which are often overlooked but can impact treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The need for expanded monitoring of adverse events in behavioral health clinical trials. Peterson, AL., Roache, JD., Raj, J., et al.[2012]

A systematic review of 115 psychotherapy study protocols revealed that while 77 protocols explicitly addressed harm, there was a lack of standardization in how harm was conceptualized and assessed, particularly regarding adverse events.

The review highlighted that although serious adverse events were defined consistently, the definitions and considerations for adverse events varied widely, suggesting a need for more standardized approaches in clinical research to effectively monitor and report harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining and assessing adverse events and harmful effects in psychotherapy study protocols: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

A study involving 60 recently bereaved widows and widowers found that they experienced significantly higher levels of suicidal ideation compared to 60 matched married individuals, with widows showing the highest levels.

The increased suicidal thoughts in bereaved individuals were linked to feelings of extreme emotional loneliness and severe depressive symptoms, suggesting that addressing these emotional factors is crucial for reducing suicide risk in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The broken heart: suicidal ideation in bereavement. Stroebe, M., Stroebe, W., Abakoumkin, G.[2015]

In a study involving 122 participants, it was found that individuals with suicide ideation after a suicide loss are at a higher risk for negative bereavement outcomes and often have a history of mental disorders.

Cognitive-behavior therapy as a grief intervention appears to be effective in reducing maladaptive grief reactions among those with suicide ideation, suggesting that they can significantly benefit from such therapy following a suicide loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of family-based cognitive-behavior grief therapy to prevent complicated grief in relatives of suicide victims: the mediating role of suicide ideation. de Groot, M., Neeleman, J., van der Meer, K., et al.[2018]

A review of 20 randomized clinical trials found that certain psychosocial interventions and one pharmacotherapy were effective in reducing suicide attempts compared to standard treatments or placebo.

The effectiveness of psychosocial interventions was notably higher when targeting high-risk suicidal individuals, suggesting that these treatments are most beneficial for those with greater immediate risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral treatments of suicidal behaviors. Definitional obfuscation and treatment outcomes. Linehan, MM.[2022]

A pilot study involving 17 older adults at risk for suicide showed that a 16-session Interpersonal Psychotherapy (IPT) intervention significantly reduced suicide ideation and depressive symptoms.

Participants also reported improvements in psychological well-being, social adjustment, and perceived social support, indicating that this adapted IPT could be beneficial for older adults in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting interpersonal psychotherapy for older adults at risk for suicide. Heisel, MJ., Talbot, NL., King, DA., et al.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

In a study involving 1,687 substance-abusing participants over 27,198 person-weeks, 12% experienced serious adverse events (SAEs), but none were deemed related to the psychosocial interventions being tested.

There were no significant differences in the incidence rates of SAEs between those receiving standard care and those receiving additional interventions like contingency management or motivational enhancement, suggesting that these psychosocial treatments are safe in terms of serious adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious adverse events in randomized psychosocial treatment studies: safety or arbitrary edicts? Petry, NM., Roll, JM., Rounsaville, BJ., et al.[2021]

In a study of 1324 discharged patients, 10.88% experienced adverse events (AEs), with medication-related AEs occurring in 90% of those affected, highlighting the significant risk of harm from neuropsychiatric treatments.

The neuropsychiatry trigger tool (NPTT) was highly effective, identifying 30 times more AEs than traditional reporting methods, suggesting it could be a valuable tool for improving patient safety and reducing harm in hospital settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Trigger Tool to Identify Adverse Events and Harm in a Neuropsychiatry Setting. Sharma, S., Kapoor, K., Nasare, N., et al.[2023]

In a study of 149 patients with complicated grief, 65% reported thoughts of wanting to die after losing a loved one, highlighting a significant risk of suicidal ideation in this population.

Among those expressing suicidal thoughts, 38% engaged in self-destructive behaviors, including 9% who attempted suicide, indicating that the severity of complicated grief symptoms and a history of suicide attempts are critical factors associated with post-loss suicidal behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect self-destructive behavior and overt suicidality in patients with complicated grief. Szanto, K., Shear, MK., Houck, PR., et al.[2019]

In a study of 58 bereaved adolescents aged 12-17, grief reactions were found to significantly influence suicide ideation through feelings of thwarted belongingness, highlighting a potential pathway for increased suicide risk.

The results suggest that clinicians should pay close attention to signs of thwarted belongingness in bereaved youth, as it may serve as an important indicator of their risk for suicidal thoughts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding grief reactions, thwarted belongingness, and suicide ideation in bereaved adolescents: Toward a unifying theory. Hill, RM., Kaplow, JB., Oosterhoff, B., et al.[2020]

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