Interventional Recruiting
NCT06639477 on ClinicalTrials.gov
Assessing Improvements in Mood and Sleep Trial
Official title: Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
- Sponsor: University of Pittsburgh
- Collaborators: Emory University, University of California, Berkeley, University of California, Los Angeles, Augusta University, National Institutes of Health (NIH), National Institute of Mental Health (NIMH)
- Enrollment: 420 (Estimated)
- Study start: 2025-05-20 (Actual)
- Primary completion: 2029-08-01 (Estimated)
- Study completion: 2030-08-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief 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.
Conditions
- Depression
- Suicidality
- Sleep
Intervention / Treatment
- Other: Treatment As Usual
- Behavioral: Active Condition
- Behavioral: Active Comparator
Primary Outcome Measures
-
Depression Symptom Response
(six months post-treatment)
The outcome is the rate of clinically significant depression symptom responses six-months post treatment, defined as having ≥50% reduction in pre-treatment depression severity six-months posttreatment. Depression severity will be assessed as total scores from the 14 non-sleep items of the clinician rated GRID Hamilton Depression Rating Scale. Lower scores on the GRID Hamilton would indicate a reduction in depression symptoms.
Countries
United States
Locations and Investigators
-
The Regents of the University of California, Los Angeles, Los Angeles, United States (Recruiting)
- Michael Irwin, PhD
- Jennifer Kruse, PhD
- Michael Iriwn, PhD (Principal Investigator)
- Jennifer Kruse, PhD
-
Augusta University, Augusta, United States (Recruiting)
- William McCall, PhD
- Jessica Britt-Thomas, PhD
- William McCall, PhD (Principal Investigator)
- Jessica Britt-Thomas, PhD
-
University of Pittsburgh, Pittsburgh, United States (Recruiting)
- Sara Sellars, M.A
- Stephen F Smagula, PhD (Principal Investigator)
- Daniel J Buysse, MD
Study Officials
- Stephen F Smagula, Ph.D (Principal Investigator) — University of Pittsburgh