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

Not Applicable

Recruiting

• Conditions: Depression; Cognitive Decline
• Interventions: Behavioral: Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression; Behavioral: Active Control

• Registration Number: NCT06627894
• Lead Sponsor: Indiana University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Study First Posted: 2024-10-04
• Study Start: 2025-03-13
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-01
• Primary Completion: 2029-10-30
• Study Completion: 2029-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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. Validated depression diagnosis (PHQ-9 > 10)
5. Willing to participate in cognitive testing
6. Access to a telephone
7. Discharge to home or an independent or assisted living facility

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression	Therapist-Assisted Internet Cognitive-Behavioral Therapy 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.
Active Control - Depression Education, Symptom Monitoring, and Usual Care	Active Control	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.

Primary Outcome Measures

Name	Time	Method
Subjective Cognitive Decline	Measured at 6-month and 12-month follow-up.	The primary outcome will be subjective cognitive decline (SCD), measured using the Cognitive Change Index self-report version (CCI-SR).

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Eskenazi Hospital; 🇺🇸 Indianapolis, Indiana, United States

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States