Comparing two 8-week programs to improve mood, sleep, and suicidal thoughts in people 55 and older.
Official title: Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
Run by University of Pittsburgh · NCT06639477 · Data updated 2026-11-12
This trial will test whether one of two weekly 8-week behavioral programs helps people aged 55+ with depression and recent suicidal thoughts or past suicide attempts sleep better and feel less depressed.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years and up |
| Sex | All |
| Enrollment | 420 (estimated) |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Status | Recruiting |
| Started | May 20, 2025 |
| Main results expected | August 2029 |
| Study ends | August 2030 |
| Registry record updated | May 19, 2026 |
| Trial ID | NCT06639477 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 55 or older with a PHQ-9 score ≥10, a past-month Scale for Suicide Ideation score ≥3 or any history of suicide attempt, elevated sleep disturbance (PROMIS t-score ≥55), and who have been on an adequate dose of antidepressant medication for at least four weeks.
✕Probably not a fit
People with active suicidal intent or plans requiring inpatient care, bipolar disorder, psychotic disorder, borderline personality disorder, dementia or incapacity to consent, moderate-to-severe substance use disorder, current CBT-I or concurrent ketamine/ECT/TMS treatment, or a life expectancy under one year are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multi-site randomized controlled trial will enroll about 420 adults age 55 and older with current depressive symptoms and either recent suicidal ideation or a past suicide attempt, across three U.S. sites (Pittsburgh, Los Angeles, Augusta). Participants will be randomized to one of two evidence-based 8-week therapy programs and will meet with a study therapist once weekly. Researchers will collect diagnostic interviews, self-report scales, and one-week continuous actigraphy monitoring around the baseline, post-treatment, and six-month visits to measure sleep, mood, cognition, and health. Certain intervention details are withheld to preserve scientific integrity while outcomes will compare changes in sleep disturbance, depressive symptoms, and suicidality over time.
Why it matters
Potential benefit: If successful, the results could identify which program more effectively reduces sleep problems, depressive symptoms, and suicidal thoughts in older adults, helping clinicians choose better treatments.
How similar studies have gone: Both programs are described as evidence-based and prior research supports behavioral sleep and psychotherapy approaches for improving mood and suicidal ideation, but direct head-to-head comparisons in older adults are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The Regents of the University of California, Los Angeles
Los Angeles, California, United States Recruiting -
Augusta University
Augusta, Georgia, United States Recruiting -
University of Pittsburgh
Pittsburgh, Pennsylvania, United States Recruiting
Study contacts
- Principal investigator: Stephen F Smagula, Ph.D — University of Pittsburgh
- Study coordinator: Sara Sellars, M.A
- Email: alberts3@upmc.edu
- Phone: 412-246-5963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.