Assessing Improvements in Mood and Sleep Trial
Recruiting now · Not applicable
Conditions studied: Depression, Suicidality, Sleep
In brief
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.
Key facts
- Study ID
- NCT06639477
- Run by
- University of Pittsburgh
- People needed
- 420
- Starts
- 2025-05-20
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2026-05-19
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 55 Years and older
- Patient Health Questionnaire -9 score of 10 or higher
- Past month Scale for Suicide Ideation score of 3 or higher OR any history of suicide attempt
- PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher
- Pharmacotherapy for depression meeting minimum adequate dose level as defined by FDA approval documents for at least 4 weeks.
You may not qualify if…
- 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.
Where it is running
- The Regents of the University of California, Los Angeles — Los Angeles, California, United States (enrolling)
- Augusta University — Augusta, Georgia, United States (enrolling)
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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