Using internet therapy to reduce depression and cognitive decline in older ICU survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.