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Recruiting NCT06627894

NCT06627894 Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)

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Clinical Trial Summary
NCT ID NCT06627894
Status Recruiting
Phase
Sponsor Indiana University
Condition Depression
Study Type INTERVENTIONAL
Enrollment 300 participants
Start Date 2025-03-13
Primary Completion 2029-10-30

Trial Parameters

Condition Depression
Sponsor Indiana University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 300
Sex ALL
Min Age 50 Years
Max Age N/A
Start Date 2025-03-13
Completion 2029-10-30
Interventions
Therapist-Assisted Internet Cognitive-Behavioral Therapy for DepressionActive Control

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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.

Eligibility Criteria

Inclusion Criteria 1. 50 years of age and older 2. Admitted to the intensive care for greater \> 48 hours 3. Able to understand and provide informed consent 4. 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) 5. Willing to participate in cognitive testing 6. Access to a telephone 7. Discharge to home or an independent or assisted living facility 8. 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. Exclusion Criteria: 1. Diagnosis of dementia or neurodegenerative disease (e.g. Alzheimer's disease, vascular dementia as per EHR and IQCODE, o

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