Comparing two 8-week programs to improve mood, sleep, and suicidal thoughts in people 55 and older.
Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults
NA · University of Pittsburgh · NCT06639477
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh (other) |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT06639477 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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
Where this trial is running
Los Angeles, California and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Depression, Suicidality, Sleep, Older Adults