RecruitingNot ApplicableNCT06639477

Assessing Improvements in Mood and Sleep Trial

Multi-site Randomized Controlled Trial Comparing the Efficacy of Behavioral Approaches to Improve Mood and Sleep in Adults


Sponsor

University of Pittsburgh

Enrollment

420 participants

Start Date

May 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study (AIMS Trial) tests treatments to improve mood and sleep in older adults (55+) who have depression with suicidal thoughts and significant sleep problems that have not improved on antidepressants. Researchers want to find better combinations of therapy and medication for this difficult-to-treat group. **You may be eligible if...** - You are 55 years old or older - You are currently taking an antidepressant medication at the proper dose for at least 4 weeks - You have significant depression symptoms (PHQ-9 score ≥ 10) - You have suicidal thoughts (Scale for Suicide Ideation score ≥ 3) OR a history of a suicide attempt - You have significant sleep disturbance or impairment **You may NOT be eligible if...** - You have active suicidal plans or are currently hospitalized for psychiatric reasons - You have bipolar disorder, a psychotic disorder, or borderline personality disorder - You are currently in active cognitive-behavioral therapy or receiving ketamine, ECT, or TMS - You have a life-limiting illness with less than 1 year to live - You have a moderate to severe substance use disorder - You work night shifts Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERTreatment As Usual

In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.

BEHAVIORALActive Condition

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.

BEHAVIORALActive Comparator

Participants receive eight \~40 minute sessions (one per week) with a therapist/health coach. Specific information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.


Locations(3)

The Regents of the University of California, Los Angeles

Los Angeles, California, United States

Augusta University

Augusta, Georgia, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT06639477


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