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Assessing Improvements in Mood and Sleep Trial

RECRUITINGN/ASponsored by University of Pittsburgh
Actively Recruiting
PhaseN/A
SponsorUniversity of Pittsburgh
Started2025-05-20
Est. completion2029-08
Eligibility
Age55 Years+
Healthy vol.Accepted
Locations3 sites

Summary

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.

Eligibility

Age: 55 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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.

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

Conditions3

DepressionSleepSuicidality

Locations3 sites

California

1 site
The Regents of the University of California, Los Angeles
Los Angeles, California, 90095
Michael Irwin, PhD310-825-8281mirwin1@ucla.edu

Georgia

1 site
Augusta University
Augusta, Georgia, 30912
William McCall, PhD716-721-6719wmccall@augusta.edu

Pennsylvania

1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Sara Albert, M.A412-246-5963alberts3@upmc.edu

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