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Assessing Improvements in Mood and Sleep Trial

This study is for people aged 55 and older who are experiencing depression, suicidal thoughts or a history of suicide attempts, and sleep problems. The goal is to compare two different approaches, both involving weekly sessions with a therapist or health coach, to see which one is more effective at improving mood, sleep, and reducing suicidal thoughts. You would already be receiving standard depression treatment from your own doctor. The study aims to enroll 420 participants across three locations in the United States. Success will be measured by how much your depression symptoms improve six months after the treatment ends. The current recruitment status is unclear.

Study design
This is a randomized control trial, meaning participants will be randomly assigned to one of two groups, with 210 participants in each group. There are 420 participants planned in total.
What's involved
You would attend eight weekly sessions with a therapist/health coach, each lasting about 40 minutes. You will also complete assessments before the program, right after it ends, and six months later, and wear a wrist device and keep a sleep diary for a week around each assessment.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for six months after the therapy program ends to assess depression symptom response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06639477

Assessing Improvements in Mood and Sleep Trial

Recruiting
NAAges 55+InterventionalTreatment
University of Pittsburgh
~420 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Treatment As UsualActive ConditionActive Comparator

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depression Symptom Response
Measured over six months post-treatment

Conditions

Depression
Suicidality
Sleep

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Depression

NCT06639477

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Augusta University

    Augusta, Georgiastudy coordinator listed

    Recruiting

  • The Regents of the University of California, Los Angeles

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Stephen F Smagula, Ph.D · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Sara Sellars, M.A
[email protected]
412-246-5963
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Depression Symptom Responsesix months post-treatment

    The outcome is the rate of clinically significant depression symptom responses six-months post treatment, defined as having ≥50% reduction in pre-treatment depression severity six-months posttreatment. Depression severity will be assessed as total scores from the 14 non-sleep items of the clinician rated GRID Hamilton Depression Rating Scale. Lower scores on the GRID Hamilton would indicate a reduction in depression symptoms.