RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02
Study Completion:2029-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06627894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 50 years of age and older
  2. 2. Admitted to the intensive care for greater \> 48 hours
  3. 3. Able to understand and provide informed consent
  4. 4. Validated depression diagnosis (PHQ-9 \> 10)
  5. 5. Willing to participate in cognitive testing
  6. 6. Access to a telephone
  7. 7. Discharge to home or an independent or assisted living facility
  1. 1. 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
  2. 2. Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
  3. 3. Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
  4. 4. Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
  5. 5. Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
  6. 6. Ischemic or hemorrhagic stroke, traumatic brain injury, or undergoing neurosurgery prior, during or after ICU stay
  7. 7. Uncorrected visual or auditory impairment including legal blindness or deaf
  8. 8. Status post tracheostomy and not able to communicate
  9. 9. Incarcerated or on parole after ICU stay

Contacts and Locations

Study Contact

Babar Khan, MD, MS
CONTACT
317-274-9132
bakhan@iu.edu
Lori Rawlings, RN, BSN
CONTACT
317-274-9052
rawlingl@regenstrief.org

Principal Investigator

Babar Khan, MD, MS
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

Eskenazi Hospital
Indianapolis, Indiana, 46202
United States
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
United States

Collaborators and Investigators

Sponsor: Indiana University

  • Babar Khan, MD, MS, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02
Study Completion Date2029-10-30

Study Record Updates

Study Start Date2025-02
Study Completion Date2029-10-30

Terms related to this study

Keywords Provided by Researchers

  • Depression
  • Cognition

Additional Relevant MeSH Terms

  • Depression
  • Cognitive Decline