Assessing Improvements in Mood and Sleep Trial

About

Brief 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.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

55 Years

Maximum Age

N/A

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