NCT06627894 Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
| NCT ID | NCT06627894 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2029-10-30 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-03-13 with a primary completion date of 2029-10-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Babar Khan, MD, MS
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT06627894 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06627894 currently recruiting?
Yes, NCT06627894 is actively recruiting participants. Contact the research team at bakhan@iu.edu for enrollment information.
Where is the NCT06627894 trial being conducted?
This trial is being conducted at Indianapolis, United States, Indianapolis, United States.
Who is sponsoring the NCT06627894 clinical trial?
NCT06627894 is sponsored by Indiana University. The principal investigator is Babar Khan, MD, MS at Indiana University. The trial plans to enroll 300 participants.
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