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Psychobehavioral Intervention for Reducing Suicide Risk

New Haven, CT

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

No Placebo-Only Group

Summary

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

See full description

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

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I have been diagnosed with Bipolar Disorder or Major Depressive Disorder.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 1, week 7, week 12 and month 6

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 1Eligibility criteria met