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Assessing Improvements in Mood and Sleep Trial
Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
Who can join
Ages 55 and older · All sexes
Full eligibility criteria
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 * Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.
About the study
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.
What is being tested
- Treatment As Usual (other)
- Active Condition (behavioral)
- Active Comparator (behavioral)
Sponsor: University of Pittsburgh · Participants: 420 · Started: May 20, 2025
Contact the study team
- Sara Sellars, M.A · Phone: 412-246-5963
- Stephen Smagula, Ph.D · Phone: 412-246-6674
Official record on ClinicalTrials.gov — NCT06639477
Locations in the U.S.
| California | The Regents of the University of California, Los Angeles, Los Angeles |
| Georgia | Augusta University, Augusta |
| Pennsylvania | University of Pittsburgh, Pittsburgh |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.