Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT06639477

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

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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

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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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