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
University of Pittsburgh
420 participants
May 20, 2025
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
Inclusion Criteria5
- 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 Criteria9
- 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
Interventions
In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
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.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06639477