Using internet therapy to reduce depression and cognitive decline in older ICU survivors
Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
This study is testing if an online therapy program can help older adults who have been in the ICU feel less depressed and think better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06627894 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of an internet-based cognitive behavioral therapy (CBT) intervention called Good Days Ahead (GDA) aimed at reducing depression and subjective cognitive decline in older adults who have survived an intensive care unit (ICU) stay. The study involves a two-arm randomized controlled trial comparing the internet CBT intervention to an active control group. Participants will be older adults aged 50 and above who have experienced moderate to severe depressive symptoms after ICU hospitalization. The goal is to determine if addressing depression can help slow cognitive decline and reduce the risk of Alzheimer's disease and related dementias.
Who should consider this trial
Good fit: Ideal candidates for this study are older adults aged 50 and above who have been admitted to the ICU for more than 48 hours and are experiencing moderate to severe depressive symptoms.
Not a fit: Patients with a diagnosis of dementia, severe mental illness, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health and cognitive outcomes for older ICU survivors, potentially lowering the risk of developing Alzheimer's disease and related dementias.
How similar studies have performed: While there have been studies on CBT for depression, this specific approach targeting cognitive decline in older ICU survivors is novel and has not been rigorously tested on a large scale.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana and 1 other locations
- Eskenazi Hospital — Indianapolis, Indiana, United States (Recruiting)
- IU Health Methodist Hospital — Indianapolis, Indiana, United States (Recruiting)
Study contacts
- Principal investigator: Babar Khan, MD, MS — Indiana University
- Study coordinator: Babar Khan, MD, MS
- Email: bakhan@iu.edu
- Phone: 317-274-9132
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.