Assessing Improvements in Mood and Sleep Trial

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Pittsburgh
Study ID
NCT06639477
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Treatment As Usual — OTHER
    In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
  • Active Condition — BEHAVIORAL
    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.
  • Active Comparator — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
May 20, 2025
Status verified
May 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Concealed Control Intervention
    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.
  • Experimental: Active Condition
    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.

Primary Outcome Measure

Depression Symptom Response [ Time Frame: six months post-treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
The Regents of the University of California, Los AngelesLos AngelesCalifornia90095
Michael Irwin, PhD
[email protected]
310-825-8281
Jennifer Kruse, PhD
[email protected]
310-206-8095
Michael Iriwn, PhD (PRINCIPAL_INVESTIGATOR)
Jennifer Kruse, PhD (SUB_INVESTIGATOR)
Augusta UniversityAugustaGeorgia30912
William McCall, PhD
[email protected]
716-721-6719
Jessica Britt-Thomas, PhD
[email protected]
706-721-3141
William McCall, PhD (PRINCIPAL_INVESTIGATOR)
Jessica Britt-Thomas, PhD (SUB_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15213
Sara Sellars, M.A
[email protected]
412-246-5963
Stephen F Smagula, PhD (PRINCIPAL_INVESTIGATOR)
Daniel J Buysse, MD (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
The Regents of the University of California, Los Angeles· Los Angeles, CAAugusta University· Augusta, GAUniversity of Pittsburgh· Pittsburgh, PA

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