BE-SMART-DR for Suicidal Thoughts

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Mood Disorders Research Program, New Haven, CTSuicidal Thoughts+4 MoreBE-SMART-DR - Behavioral
Eligibility
16 - 29
All Sexes
What conditions do you have?
Select

Study Summary

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

Eligible Conditions
  • Suicidal Thoughts
  • Suicide
  • Mood Disorders
  • Depression
  • Bipolar Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

5 Primary · 0 Secondary · Reporting Duration: baseline, week 1, week 7, week 12 and month 6

Month 6
Change from baseline in BE-SMART-DR Suicidal Ideation/Propensity (SI/P) using Beck Scale for Suicide Ideation (SSI)
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)
up to 6 months
Change from baseline in BE-SMART-DRs Daily Rhythm (DR) using the Social Rhythm Metric (SRM)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

control comparator condition
1 of 2
BE-SMART-DR
1 of 2

Active Control

Experimental Treatment

128 Total Participants · 2 Treatment Groups

Primary Treatment: BE-SMART-DR · No Placebo Group · N/A

BE-SMART-DR
Behavioral
Experimental Group · 1 Intervention: BE-SMART-DR · Intervention Types: Behavioral
control comparator condition
Behavioral
ActiveComparator Group · 1 Intervention: psychoeducational control comparator condition (CC) · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, week 1, week 7, week 12 and month 6

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,703 Previous Clinical Trials
21,174,681 Total Patients Enrolled
American Foundation for Suicide PreventionOTHER
29 Previous Clinical Trials
8,727 Total Patients Enrolled
1 Trials studying Suicidal Thoughts
60 Patients Enrolled for Suicidal Thoughts
Hilary Blumberg, MDPrincipal InvestigatorYale University

Eligibility Criteria

Age 16 - 29 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have attempted suicide in the past or have a high score on a suicidal behavior assessment called SSI.
You have been diagnosed with bipolar disorder type I, type II, or otherwise specified, or major depressive disorder according to the DSM5.

Who else is applying?

What state do they live in?
New York100.0%
How old are they?
65+100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.