Can talk therapy beat insomnia and depression in seniors? new study aims to find out.
NCT ID NCT06639477
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two behavioral approaches to see which works better for improving mood, sleep, and reducing suicide risk in adults aged 55 and older with depression. Participants will complete interviews, questionnaires, and wear a sleep tracker for 8 weeks. The goal is to find the most effective way to help older adults feel better and sleep well.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 420 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Augusta University
RECRUITINGAugusta, Georgia, 30912, United States
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The Regents of the University of California, Los Angeles
RECRUITINGLos Angeles, California, 90095, United States
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University of Pittsburgh
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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Other studies related to the condition(s) this trial covers.
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- Project QUIT+: adapting and testing a smoking cessation intervention for transgender and gender expansive individuals
- Evaluation of a wearable sleep monitoring platform with acoustic stimulation for mood regulation
- Can a nudge toward healthy habits boost an online depression and anxiety program?
- Can brain activity reveal why some people with depression lose motivation and pleasure?