Actively Recruiting
Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults with Depression and Suicidality
Led by University of Pittsburgh · Updated on 2026-05-19
420
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Pittsburgh
Lead Sponsor
E
Emory University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a multi-site randomized control trial to evaluate two different behavioral approaches aimed at improving mood, sleep, and suicidality symptoms in adults aged 55 and older who currently experience depression and have an additional suicide risk factor. The study will include 420 participants across three sites in the United States and aims to identify which program better helps with issues like trouble sleeping and bad moods. Participants will be randomly assigned to one of two evidence-based therapy programs, each consisting of eight weekly sessions lasting about 40 minutes with a therapist or health coach. Both programs include educational content and may involve guided discussions, activities, and support related to stress, sleep problems, and depression. Throughout the 8-week therapy period, participants will wear an actigraphy watch to monitor activity and sleep, and complete phone assessments every other week starting at week 2. Participants will attend three main study visits: before starting therapy, immediately after therapy ends, and six months later. During these visits, assessments of sleep, mood, cognition, and health will be completed. In addition, participants will continue phone assessments monthly after therapy until six months post-therapy and have a final call 12 months after therapy ends. The primary outcome measured is depression symptom response six months after treatment, with additional focus on changes in suicidal ideation and behavior.
CONDITIONS
Brief Title
Assessing Improvements in Mood and Sleep Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 years or older
- Patient Health Questionnaire-9 score of 10 or higher indicating depression symptoms
- Current suicidal thoughts with a Scale for Suicide Ideation score of 3 or higher in the past month, or any history of suicide attempt
- PROMIS Sleep Disturbance or impairment scale t-scores of 55 or higher indicating sleep problems
- On adequate pharmacotherapy for depression for at least 4 weeks at minimum FDA approved dose
You will not qualify if you...
- Active suicide planning with intent or judged too high risk for outpatient treatment, or currently inpatient
- Diagnosis of bipolar disorder
- Diagnosis of psychotic disorder
- Diagnosis of borderline personality disorder
- Currently receiving active cognitive or behavioral therapy (e.g., CBT-I), esketamine (ketamine), ECT, or TMS treatment
- Illness with life expectancy less than 1 year or plans to leave study area
- Inability to consent or diagnosis of dementia
- Active moderate or severe substance use disorder
- Working night shifts
- Any physical, mental, or neurological condition making study participation unsafe or impractical
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants meet with a study therapist once a week for 8 weeks to complete the assigned behavioral program designed to improve mood and sleep.
Weekly visits for 8 weeks
Duration - Up to 12 months after treatment ends
Participants complete assessments and phone interviews to monitor mood, sleep, and health outcomes up to 12 months after therapy ends.
3 main assessment visits and phone assessments every other week during treatment, then monthly calls until 6 months post-treatment, plus one call at 12 months post-treatment
Trial Site Locations
Total: 3 locations
1
The Regents of the University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
2
Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
Research Team
S
Sara Sellars, M.A
S
Stephen Smagula, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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