No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
55 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
University of Pittsburgh · Other
Who this trial is looking for
This trial is looking for older adults aged 55 and up with depression symptoms and a history of suicidal thoughts or attempts. Participants will undergo interviews, answer questionnaires, and wear a device to monitor sleep for 8 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I am 55 years or older
I have a Patient Health Questionnaire score of 10 or higher
I have a recent suicidal ideation score of 3 or higher or a history of suicide attempt
I have a sleep disturbance score of 55 or higher
I have been taking depression medication at an adequate dose for at least 4 weeks
You may not be able to join if
I have active plans to commit suicide
I have bipolar disorder
I have a psychotic disorder
I have borderline personality disorder
I am receiving active Cognitive/Behavioral Therapy or esketamine treatment
I have a serious illness that affects my life expectancy
I cannot provide consent or have dementia
I have a severe substance use disorder
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 intervi…
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.
Trial Locations
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Eligibility 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 depressio…
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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