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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Treatment As Usual
Other interventionIn this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
Active Condition
BehavioralParticipants 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.
Active Comparator
BehavioralParticipants 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.
Treatment groups
420 Participants
are divided into 2 treatment groupsGroup A: Concealed Control InterventionActive comparator 2 interventions
Group B: Active ConditionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Depression Symptom Response
The outcome is the rate of clinically significant depression symptom responses six-months post treatment, defined as having ≥50% reduction in pre-treatment depression severity six-months posttreatment. Depression severity will be assessed as total scores from the 14 non-sleep items of the clinician rated GRID Hamilton Depression Rating Scale. Lower scores on the GRID Hamilton would indicate a reduction in depression symptoms.
Time frame
six months post-treatmentSecondary outcomes
1
Change in Suicide Ideation Severity
Measuring rates of clinically significant past-month active SI at the six-month follow-up defined as Columbia Suicide Severity Rating Scale (CSSR) ideation dimension scores ≥ 3. This level on the CSSR, equivalent to having at least SI with a method, was identified as an optimal cut-off for predicting future suicide death. Lower scores on the Columbia Suicide Severity Rating Scale would indicate lower levels of suicide ideation.
Time frame
from Enrollment to the end of treatment at 6-months post-intervention2
Suicide Behavior Outcomes
Any suicidal behaviors over the six-month follow-up defined as escalating planning, suicide attempt, or suicide-related hospitalization.
Time frame
from Enrollment to the end of treatment at 6-months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
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