Recruiting

Assessing Improvements in Mood and Sleep Trial

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.

ClinicalTrials.gov IDNCT06639477

PhaseNA

Enrollment420

SponsorUniversity of Pittsburgh

Age55 Years

SexALL

I'm interested View official listing

Conditions studied

Depression, Suicidality, Sleep

About this study

Interventions

Other: Treatment As Usual — In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
Behavioral: Active Condition — Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
Behavioral: Active Comparator — Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

Primary outcomes

Depression Symptom Response (six months post-treatment)

Eligibility information

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.

Study locations

The Regents of the University of California, Los Angeles, Los Angeles, California 90095 United States
Augusta University, Augusta, Georgia 30912 United States
University of Pittsburgh, Pittsburgh, Pennsylvania 15213 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.