Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
ADEPT-ICU
2 other identifiers
interventional
300
1 country
2
Brief Summary
Depression affects one-third of intensive care unit (ICU) survivors and represents a potentially modifiable target to slow cognitive decline and reduce the risk of Alzheimer's disease and related dementias (ADRD). Our multi-PI team proposes a two-arm RCT called ADEPT-ICU (Attenuating DEPression with Internet CBT to Slow Cognitive Decline in Older ICU Survivors), which will test the efficacy of an internet CBT intervention called Good Days Ahead (GDA) to reduce the burden of subjective cognitive decline (SCD) in older ICU survivors with moderate to severe depressive symptoms after ICU hospitalization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Mar 2025
Longer than P75 for not_applicable depression
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2024
CompletedFirst Posted
Study publicly available on registry
October 4, 2024
CompletedStudy Start
First participant enrolled
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 30, 2029
December 17, 2025
October 1, 2025
4.6 years
October 3, 2024
December 13, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective Cognitive Decline
The primary outcome will be subjective cognitive decline (SCD), measured using the Cognitive Change Index self-report version (CCI-SR).
Measured at 6-month and 12-month follow-up.
Secondary Outcomes (2)
Cognition status
Measured at 6-month and 12-month follow-up.
Quality of Life physical and mental component status
Measured at 6-month and 12-month follow-up.
Study Arms (2)
Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression
EXPERIMENTALParticipants will complete nine 45-minute sessions of an internet CBT for depression called Good Days Ahead (GDA; MindStreet, Inc.) with 20 minutes of therapist assistance per session on the phone over six months.
Active Control - Depression Education, Symptom Monitoring, and Usual Care
ACTIVE COMPARATORParticipants will review nine 45-minute segments of depression education material on their own with 20 minutes of therapist assistance per segment on the phone over six months. They will also have access to and could receive current depression care in the targeted healthcare systems.
Interventions
Depression education, symptom monitoring, and standard depression care
Good Days Ahead (MindStreet, Inc.)
Eligibility Criteria
You may qualify if:
- years of age and older
- Admitted to the intensive care for greater \> 48 hours
- Able to understand and provide informed consent
- Elevated depressive symptoms, defined as Screening PHQ-9 or PHQ-8 ≥ 10 or Screening PHQ-9 or PHQ-8 = 5-9 with the presence a core symptom of anhedonia (PHQ-9 or PHQ-8 Item 1) or depressed mood (PHQ-9 or PHQ-8 Item 2)
- Willing to participate in cognitive testing
- Access to a telephone
- Discharge to home or an independent or assisted living facility
- Response is a 1,2, or 3 on PHQ-9 or PHQ-8 item 7, answered yes to "Have you experienced a change in your memory or other aspect of thinking in the past 1 to 3 years?", or score in the 25% percentile or lower on the Montreal Cognitive Assessment (MOCA) based on normative data which account for age, gender, race, ethnicity and education.
You may not qualify if:
- Diagnosis of dementia or neurodegenerative disease (e.g. Alzheimer's disease, vascular dementia as per EHR and IQCODE, or Parkinson's disease) or on anti-dementia medications prior to ICU stay
- Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
- Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
- Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
- Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
- Ischemic or hemorrhagic stroke, traumatic brain injury, or undergoing neurosurgery prior, during or after ICU stay
- Uncorrected visual or auditory impairment including legal blindness or deaf
- Status post tracheostomy and not able to communicate
- Incarcerated or on parole after ICU stay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- National Institute on Aging (NIA)collaborator
Study Sites (2)
Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Babar Khan, MD, MS
Indiana University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The unblinded study coordinator is aware of randomization. The investigator and study team members responsible for the delivery of the intervention will be unblinded. The study team staff performing outcomes assessments and the investigators overseeing this process will be blinded.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 3, 2024
First Posted
October 4, 2024
Study Start
March 13, 2025
Primary Completion (Estimated)
October 30, 2029
Study Completion (Estimated)
October 30, 2029
Last Updated
December 17, 2025
Record last verified: 2025-10