RECRUITING

Assessing Improvements in Mood and Sleep Trial

Description

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.

Conditions

DepressionSuicidalitySleep
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Related Conditions:

DepressionSuicidalitySleep

Study Overview

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Study Details

Study overview

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.

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

Assessing Improvements in Mood and Sleep Trial

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Regents of the University of California, Los Angeles, Los Angeles, California, United States, 90095

Augusta

Augusta University, Augusta, Georgia, United States, 30912

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pittsburgh,

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

Study Record Dates

2030-08