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Psychobehavioral Intervention for Reducing Suicide Risk

N/A
Recruiting
Led By Hilary Blumberg, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with Diagnostic and Statistical Manual 5 (DSM5) Bipolar Disorder (BD) I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD)
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 1, week 7, week 12 and month 6
Awards & highlights

Study Summary

This trial is testing a new suicide prevention intervention that could be widely used to help reduce suicide rates.

Who is the study for?
This trial is for young individuals with Bipolar Disorder or Major Depressive Disorder who have attempted suicide or have significant suicidal thoughts. They must be able to consent and not be pregnant, overly manic, psychotic, or under certain substance influences. Those with severe medical conditions or undergoing specific psychotherapies are excluded.Check my eligibility
What is being tested?
The study tests BE-SMART-DR, a non-drug intervention aiming to regularize daily rhythms like sleep to reduce suicide risk in adolescents and young adults. It's compared against a psychoeducational control condition to measure effectiveness.See study design
What are the potential side effects?
Since the intervention is psychobehavioral rather than medicinal, traditional side effects associated with drugs may not apply. However, participants might experience emotional discomfort when discussing sensitive topics during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Bipolar Disorder or Major Depressive Disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 1, week 7, week 12 and month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 1, week 7, week 12 and month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Concise Health Risk Tracking Scale (CHRT)
Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Brief Social Rhythm Scale (BSRS)
Change from baseline in BE-SMART-DRs Daily Rhythms (DR) using the Pittsburgh Sleep Quality Index (PSQI)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: BE-SMART-DRExperimental Treatment1 Intervention
Participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.
Group II: control comparator conditionActive Control1 Intervention
Matched for experimental, participation will include research clinical/behavioral interviews and symptom self-ratings, magnetic resonance imaging (MRI) scanning, actigraphy wearables, and use of smart phones for ecological momentary assessment (EMA). Subjects will participate in 12 weekly sessions and 6-month in person follow-up.

Find a Location

Who is running the clinical trial?

American Foundation for Suicide PreventionOTHER
33 Previous Clinical Trials
9,647 Total Patients Enrolled
1 Trials studying Suicidal Thoughts
60 Patients Enrolled for Suicidal Thoughts
Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,313 Total Patients Enrolled
Hilary Blumberg, MDPrincipal InvestigatorYale University

Media Library

BE-SMART-DR Clinical Trial Eligibility Overview. Trial Name: NCT05317481 — N/A
Suicidal Thoughts Research Study Groups: BE-SMART-DR, control comparator condition
Suicidal Thoughts Clinical Trial 2023: BE-SMART-DR Highlights & Side Effects. Trial Name: NCT05317481 — N/A
BE-SMART-DR 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317481 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being sought for this research project?

"The trial is still recruiting patients if the information on clinicaltrials.gov is accurate. According to the website, the trial was posted on 8/2/2022 and last updated 8/3/2022. There should be 128 enrollees at 2 different locations by the end of recruitment."

Answered by AI

To whom does this clinical trial offer the opportunity to participate?

"To be eligible for this study, 128 patients between the ages of 16 and 29 must present with suicidal ideation as well as a history of at least one suicide attempt and/or a score of 3 or higher on the SSI. Patients must also meet the DSM5 criteria for Bipolar disorder I, II or Otherwise Specified (OS) or Major Depressive Disorder (MDD)."

Answered by AI

Is this research project open to people over the age of 55?

"This particular trial is searching for participants that fall in the 16-29 year old age bracket."

Answered by AI

What is the largest group size that has been observed in this trial?

"That is correct. The clinical trial was originally posted on 8/2/2022 and is currently recruiting 128 patients from 2 centres."

Answered by AI

Who else is applying?

What state do they live in?
New York
How old are they?
65+
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
2022. "Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05317481.
All > Depression New York > Bipolar Disorder
~40 spots leftby Mar 2025
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