Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
Recruiting · NCT06627894 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Active ControlTherapist-Assisted Internet Cognitive-Behavioral Therapy for Depression
What this trial is about
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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 50 years of age and older
- Admitted to the intensive care for greater \> 48 hours
- Able to understand and provide informed consent
- 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)
- Willing to participate in cognitive testing
- Access to a telephone
- Discharge to home or an independent or assisted living facility
- 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
- 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
- Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
- Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
- Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
- Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
- Ischemic or hemorrhagic stroke, traumatic brain injury, or undergoing neurosurgery prior, during or after ICU stay
- Uncorrected visual or auditory impairment including legal blindness or deaf
- Status post tracheostomy and not able to communicate
- Incarcerated or on parole after ICU stay
Where it is running
2 locations listed across 1 US state.
- Eskenazi Hospital - Indianapolis, Indiana, United States
- IU Health Methodist Hospital - Indianapolis, Indiana, United States