RecruitingNot ApplicableNCT06627894

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


Sponsor

Indiana University

Enrollment

300 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Inclusion Criteria8

  • 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.

Exclusion Criteria9

  • 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

Interventions

BEHAVIORALTherapist-Assisted Internet Cognitive-Behavioral Therapy for Depression

Good Days Ahead (MindStreet, Inc.)

BEHAVIORALActive Control

Depression education, symptom monitoring, and standard depression care


Locations(2)

Eskenazi Hospital

Indianapolis, Indiana, United States

IU Health Methodist Hospital

Indianapolis, Indiana, United States

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NCT06627894


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