Assessing Improvements in Mood and Sleep Trial

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

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.

Sponsors & Collaborators

• Emory University

  collaborator OTHER

• University of California, Berkeley

  collaborator OTHER

• University of California, Los Angeles

  collaborator OTHER

• Augusta University

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Pittsburgh

  lead OTHER

Principal Investigators

• Stephen F Smagula, Ph.D · University of Pittsburgh

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-20

Primary Completion

2029-08-31

Completion

2030-08-31

Countries

• United States

Study Locations