Recruiting

Observational StudyAssessing Improvements in Mood and Sleep Trial

Sponsor:

University of Pittsburgh

Code:

NCT06639477

Conditions

Depression

Suicidality

Sleep

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Treatment As Usual

Active Condition

Active Comparator

Study Details

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

Study ID

NCT06639477

Start date

May 20, 2025

Status verified date

May, 2026

Completion date

Aug, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not 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
Any physical, mental, or neurological condition that would make participation in the study, including either treatment arm, unsafe or infeasible.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Concealed Control Intervention

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.

experimental: Active Condition

Interventions

Treatment As Usual

In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.

Active Condition

Active Comparator

Primary outcome measure

Depression Symptom Response [ Time Frame: six months post-treatment ]

Central Contacts and Locations

Central contacts

Sara Sellars, M.A

412-246-5963 alberts3@upmc.edu

Stephen Smagula, Ph.D

412-246-6674 smagulasf@upmc.edu

Locations

The Regents of the University of California, Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Michael Irwin, PhD

310-825-8281 mirwin1@ucla.edu

Jennifer Kruse, PhD

310-206-8095 jkruse@mednet.ucla.edu

Principal Investigator:

Michael Iriwn, PhD

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

William McCall, PhD

716-721-6719 wmccall@augusta.edu

Jessica Britt-Thomas, PhD

706-721-3141 jebritt@augusta.edu

Principal Investigator:

William McCall, PhD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Sara Sellars, M.A

412-246-5963 alberts3@upmc.edu

Principal Investigator:

Stephen F Smagula, PhD

More Information

Sponsor

University of Pittsburgh

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

Older Adults
Depression

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-05-19.