Assessing Improvements in Mood and Sleep Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorUniversity of Pittsburgh
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Treatment As Usual
- Active Condition
- Active Comparator
Treatment groups
420 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Pittsburgh
Lead sponsor
Emory University
Collaborator
University of California, Berkeley
Collaborator
University of California, Los Angeles
Collaborator
Augusta University
Collaborator
National Institutes of Health (NIH)
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov