NCT06627894

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression	Good Days Ahead (MindStreet, Inc.)
BEHAVIORAL	Active Control	Depression education, symptom monitoring, and standard depression care

Timeline

• Start date: 2025-03-13
• Primary completion: 2029-10-30
• Completion: 2029-10-30
• First posted: 2024-10-04
• Last updated: 2025-12-17

Locations

2 sites across 1 country: United States