RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

OTHER

Treatment As Usual

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

BEHAVIORAL

Active 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.

BEHAVIORAL

Active Comparator

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