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

NCT ID: NCT06627894

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-13
• Study Completion Date: 2029-10-30

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.

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.

Conditions

Depression; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression

Intervention Type: BEHAVIORAL

Good Days Ahead (MindStreet, Inc.)

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.

Group Type: ACTIVE_COMPARATOR

Active Control

Intervention Type: BEHAVIORAL

Depression education, symptom monitoring, and standard depression care

Interventions

Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression

Good Days Ahead (MindStreet, Inc.)

Intervention Type: BEHAVIORAL

Active Control

Depression education, symptom monitoring, and standard depression care

Intervention Type: BEHAVIORAL

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, 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Babar Khan, MD, MS

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Babar Khan, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Eskenazi Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

IU Health Methodist Hospital

Indianapolis, Indiana, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Babar Khan, MD, MS

Role: CONTACT

bakhan@iu.edu

317-274-9132

Lori Rawlings, RN, BSN

Role: CONTACT

rawlingl@regenstrief.org

317-274-9052

Facility Contacts

Babar Khan, MD, MS

Role: primary

bakhan@iu.edu

317-274-9132

Babar Khan, MD, MS

Role: primary

bakhan@iu.edu

317-274-9132

Other Identifiers

1R01AG084754-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22761

Identifier Type: -

Identifier Source: org_study_id