Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
420 participants
INTERVENTIONAL
2025-05-20
2030-08-31
Brief Summary
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Participants will complete diagnostic interviews, self-report scales, and wear an actigraphy device for the 8 weeks starting at the baseline visit.
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Detailed Description
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Participants will be randomized to receive one of two evidence-based programs that are designed to help improve outcomes. Each group will contain 210 participants. Researchers will enroll a total of 140 participants (70 in each group) at the University of Pittsburgh. Both groups will meet with a study therapist once a week to complete the assigned 8-week program. To determine which (if any) program has beneficial effect over time, researchers will ask participants to complete assessments of their sleep, mood, and health before and after the therapy. Certain information regarding the nature of the interventions is withheld to protect the scientific integrity of the study design.
There are three main study visits where participants will complete assessments about their sleep, mood, cognition and health. These would be:
* Before the therapy program begins
* Right after it ends
* Six months later
Around the time of each visit, researchers will ask participants to wear an actigraphy watch on their wrist 24/7 for a week while completing a sleep diary. The actigraphy watch is a wrist-watch like device that measures movement so that researchers can estimate the participant's activity and sleep levels.
After the first main visit is complete, participants will be randomly assigned to one of two programs that include meeting with a study clinician for 30-50 minutes each week for 8 weeks (8 sessions total). Both groups will receive educational information and, depending on the group the participants are assigned to, may include guided discussions, activities, and/or support addressing any stressors participants face, sleep problems, and/or depression.
During the therapy period, researchers would ask participants to continue wearing the actigraphy watch. Researchers would also ask participants to answer questions on the phone with study staff weekly (that would take about 30-40 minutes a week).
After the participant's last therapy session, researchers would repeat the phone assessments once a month until the last main visit occurs (six-months after therapy ends).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Treatment As Usual
In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
Active Comparator
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 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.
Treatment As Usual
In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
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.
Interventions
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Treatment As Usual
In this trial, all participants will have depression symptoms and will be receiving TAU from their own doctors.
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.
Active Comparator
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
ALL
No
Sponsors
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Emory University
OTHER
University of California, Berkeley
OTHER
University of California, Los Angeles
OTHER
Augusta University
OTHER
National Institutes of Health (NIH)
NIH
National Institute of Mental Health (NIMH)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Stephen Smagula
Associate Professor of Psychiatry
Principal Investigators
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Stephen F Smagula, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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The Regents of the University of California, Los Angeles
Los Angeles, California, United States
Augusta University
Augusta, Georgia, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY24030049
Identifier Type: -
Identifier Source: org_study_id
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