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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Cognitive Decline
• Intervention / Treatment: Behavioral: Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression; Behavioral: Active Control

Detailed Description

Alzheimer's disease and related dementias (ADRD) affect 47 million people worldwide with an annual global cost of $818 billion. The risk of developing ADRD is disproportionately borne by older adults with multiple chronic conditions from underrepresented racial and ethnic groups (URGs). One such high risk group is older survivors of critical illness who were admitted to the intensive care units (ICUs). Nearly half of ICU survivors experience subjective cognitive decline(SCD), i.e., perceived decline in memory and thinking even with normal objective cognitive data. With over 5 million adult ICU admissions in the US each year, an intervention reducing SCD in older ICU survivors could significantly prevent or lower the incidence of ADRD. Thus, there is an urgent need for an inclusive randomized controlled trial (RCT) to rigorously test whether a novel, accessible, and scalable intervention can reduce SCD in a diverse cohort of older ICU survivors. One potential target for such interventions is post-ICU depression, which affects about one-third of ICU survivors. To date, there are no large scale RCTs which have rigorously tested whether depression focused psychotherapies, such as cognitive behavioral therapy (CBT), reduce SCD in a diverse cohort of older ICU survivors with depression.

We propose a two-arm, randomized, parallel-group, assessor-blinded clinical trial to evaluate the efficacy of internet CBT for depression compared to an active control in reducing SCD and slowing cognitive decline in older ICU survivors with post-ICU depression. The total duration of the intervention will be 6 months from randomization.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Babar Khan, MD, MS; Phone Number: 317-274-9132; Email: bakhan@iu.edu
• Study Contact Backup: Name: Lori Rawlings, RN, BSN; Phone Number: 317-274-9052; Email: rawlingl@regenstrief.org

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Methodist Hospital
      • Contact: Babar Khan, MD, MS; Phone Number: 317-274-9132; Email: bakhan@iu.edu
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Eskenazi Hospital
      • Contact: Babar Khan, MD, MS; Phone Number: 317-274-9132; Email: bakhan@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, or Parkinson's disease) or on anti-dementia medications prior to ICU stay
2. Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
3. Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
4. Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
5. Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
6. Ischemic or hemorrhagic stroke, traumatic brain injury, or undergoing neurosurgery prior, during or after ICU stay
7. Uncorrected visual or auditory impairment including legal blindness or deaf
8. Status post tracheostomy and not able to communicate
9. Incarcerated or on parole after ICU stay

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression; Participants 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.	Behavioral: Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression; Good Days Ahead (MindStreet, Inc.)
Active Comparator: Active Control - Depression Education, Symptom Monitoring, and Usual Care; Participants 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.	Behavioral: Active Control; Depression education, symptom monitoring, and standard depression care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognition status	Repeatable Battery for Assessment of Neuropsychological Status (RBANS)	Measured at 6-month and 12-month follow-up.
Quality of Life physical and mental component status	Medical Outcome Study Short Form (SF-36)	Measured at 6-month and 12-month follow-up.

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Babar Khan, MD, MS, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2025
• Primary Completion (Estimated): October 30, 2029
• Study Completion (Estimated): October 30, 2029

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 3, 2024
• First Posted (Actual): October 4, 2024

Study Record Updates

• Last Update Posted (Actual): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Depression; Cognition
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Cognition Disorders; Behavior; Cognitive Dysfunction; Depression
• Other Study ID Numbers: 22761; 1R01AG084754-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No