Assessing Improvements in Mood and Sleep Trial

Launched by UNIVERSITY OF PITTSBURGH · Oct 10, 2024

Keywords

ClinConnect Summary

The Assessing Improvements in Mood and Sleep Trial is a research study aimed at helping people aged 55 and older who are experiencing symptoms of depression, difficulty sleeping, and potential suicidal thoughts or behaviors. The trial will compare two different treatment approaches to find out which one works best in improving mood, sleep quality, and reducing suicidality. If you or someone you know is interested in participating, you must meet certain criteria, including having a depression score of 10 or higher and a recent history of suicidal thoughts or attempts.

Participants in this trial will take part in interviews and complete questionnaires to assess their mental health, as well as wear a device that tracks their sleep patterns for eight weeks. It's important to note that this study is not yet recruiting, and those with specific mental health conditions, active treatment plans, or serious health issues may not be eligible. Overall, this trial aims to find effective ways to support older adults dealing with challenging mental health issues.

Gender

ALL

Eligibility criteria

• 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