Actively Recruiting
Assessing Improvements in Mood and Sleep Trial
Led by University of Pittsburgh · Updated on 2025-06-05
420
Participants Needed
3
Research Sites
271 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing Improvements in Mood and Sleep Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 at or above minimum adequate dose for at least 4 weeks
You will not qualify if you...
- Active suicide planning with intent or judged too high risk for outpatient treatment or currently inpatient
- Bipolar disorder
- Psychotic disorder
- Borderline personality disorder
- Current cognitive behavioral therapy, esketamine (ketamine) treatment, or active phase of ECT/TMS
- Illness with life expectancy less than 1 year or plans to leave study area
- Incapacity to consent or dementia diagnosis
- Active moderate or greater substance use disorder
- Active night-shift work
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Regents of the University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Sara Sellars, M.A
CONTACT
S
Stephen Smagula, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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