Assessing Improvements in Mood and Sleep Trial (NCT06639477)
🩺 Plain-English Summary (8th-Grade Level)
This is a multi-site randomized control trial involving people age 55+ years who have current depression symptoms plus another suicide risk indicator (either current suicidal ideation or a past history of attempt). Our goal is evaluate which of two different approaches works best to improve things like trouble sleeping, bad moods, and any suicidality. Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (11 items).
Location: The Regents of the University of California, Los Angeles — Los Angeles, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Active suicide planning with intent or clinical judgement that suicide risk is too high for outpatient treatment OR being currently treated at an inpatient unit.
- Bipolar disorder
- Psychotic disorder
- Borderline personality disorder.
- Active Cognitive/Behavioral Therapy (e.g., CBT-I), current or upcoming esketamine (ketamine) treatment, or active phase of ECT/TMS treatment course.
- Illness with life expectancy of less than 1 year or plans to leave the study area
- Incapacity to consent/dementia diagnosis
- Active substance use disorder of at least moderate severity
- Active night-shift work
- Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (3 Sites)
- The Regents of the University of California, Los Angeles — Los Angeles, California
- Augusta University — Augusta, Georgia
- University of Pittsburgh — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.