Reducing Suicide Risk in Adolescents and Young Adults Via a Psychobehavioral Intervention to Regularize Daily Rhythms
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT05317481
- Status
- Completed
Conditions
- Bipolar Disorder
- Major Depressive Disorder
- Mood Disorders
- Suicidal Ideation
- Suicide
Eligibility Criteria
- Sex
- ALL
- Age
- 16 Years - 29 Years
- Healthy Volunteers
- Not accepted
Interventions
- BE-SMART-DR — BEHAVIORALTherapy that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk
- psychoeducational control comparator condition (CC) — BEHAVIORALStructured sessions, matched for BE-SMART-DR session number and time, that will emphasize established strategies to manage health and well being
Study Details
The purpose of this study is to advance a non-pharmacologic suicide preventive intervention with wide dissemination potential as an innovative high-yield solution to reduce suicide rates. The investigators aim to achieve this with this study of Brain Emotion Circuitry Self-Monitoring and Regulation Therapy for Daily Rhythms (BE-SMART-DR), that provides self-directed strategies to regularize sleep and other DRs to reduce short-term suicide risk that can be used lifelong to potentially also reduce long-term suicide risk.
Key Dates
- Start date
- Apr 1, 2022
- Status verified
- Mar 2026
- Primary completion
- Mar 31, 2025
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 65 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: BE-SMART-DRParticipation 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.
- Active Comparator: control comparator conditionMatched 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.
Primary Outcome Measure
Mean Score Measuring Suicidal Ideation/Propensity (SI/P) Using Concise Health Risk Tracking Scale-Self Reported (CHRT-SR) to Assess for Propensity [ Time Frame: Baseline (pre- intervention), 6 weeks (midpoint of intervention), 12 weeks (immediately after the intervention) ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Magnetic Resonance Research Center | New Haven | Connecticut | 06510 | - |
| Mood Disorders Research Program | New Haven | Connecticut | 06510 | - |
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