No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
50 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
300 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for older adults who were in intensive care and are experiencing depression and cognitive decline. Participants will use an online program to help manage their depression.
Are You a Good Fit for This Trial?
You may be able to join if
I am 50 years old or older
I was in intensive care for more than 48 hours
I can understand and give consent
I have elevated depressive symptoms
I am willing to participate in cognitive testing
I have access to a telephone
I have been discharged to home or an independent or assisted living facility
I have noticed changes in my memory or thinking
You may not be able to join if
I have been diagnosed with dementia or a neurodegenerative disease
I have a diagnosis of severe mental illness
I have persistent psychotic symptoms after my ICU stay
I have a recent or recurrent alcohol or substance use disorder
My life expectancy is less than 1 year
I have had a stroke or traumatic brain injury recently
I have uncorrected vision or hearing impairment
I am currently incarcerated or on parole
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 o…
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
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