Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06627894
- Status
- Recruiting
Conditions
- Cognitive Decline
- Depression
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression — BEHAVIORALGood Days Ahead (MindStreet, Inc.)
- Active Control — BEHAVIORALDepression education, symptom monitoring, and standard depression care
Study Details
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.
Key Dates
- Start date
- Mar 13, 2025
- Status verified
- Oct 2025
- Primary completion
- Oct 30, 2029
- Completion
- Oct 30, 2029
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention - Internet Cognitive-Behavioral Therapy (CBT) for DepressionParticipants 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 Comparator: Active Control - Depression Education, Symptom Monitoring, and Usual CareParticipants 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 Measure
Subjective Cognitive Decline [ Time Frame: Measured at 6-month and 12-month follow-up. ]
Central Contacts
- Babar Khan, MD, MS317-274-9132
- Lori Rawlings, RN, BSN317-274-9052
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eskenazi Hospital | Indianapolis | Indiana | 46202 | |
| IU Health Methodist Hospital | Indianapolis | Indiana | 46202 |
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