Attenuating DEPression with Internet CBT to Slow Cognitive Decline in Older ICU Survivors (ADEPT-ICU)
B
Babar Khan, MD
Primary Investigator
Enrolling By Invitation
50 years - 100 years
All
Phase
N/A
300 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
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. If our randomized controlled trial (RCT) is successful, the GDA intervention could be an efficacious, accessible, and scalable approach to reduce the burden of SCD, slow cognitive decline, and improve quality of life (QoL) in older ICU survivors.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Research staff will review the EHR of ICU patients for eligibility and approach their clinical teams to further clarify inclusion/exclusion criteria. Research staff will continue to follow ICU patients during their hospital course until hospital discharge. At the time of discharge, screened participants will undergo additional testing with the PHQ-9 to confirm depression criterion for eligibility. If they are eligible, we will conduct additional screening about their history of severe mental illness. We will also include a brief interview to obtain a mental health history using the screening psychiatric questions form. Once eligibility is confirmed, patients will be enrolled into the study.
Detailed description of study
What will happen during the study?
- We propose a two-arm, randomized, parallel-group, assessor-blinded clinical trial to evaluate the efficacy of internet CBT for depression compared to an active control in reducing SCD and slowing cognitive decline in older ICU survivors with post-ICU depression.
- The total duration of the intervention will be 6 months from randomization.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Depression
-
Age: 50 years - 100 years
-
Gender: All
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. Validated depression diagnosis (PHQ-9 > 10)
5. Willing to participate in cognitive testing
6. Access to a telephone
7. Discharge to home or an independent or assisted living facility
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
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. Validated depression diagnosis (PHQ-9 > 10)
5. Willing to participate in cognitive testing
6. Access to a telephone
7. Discharge to home or an independent or assisted living facility
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
Updated on
29 Jan 2025.
Study ID: PULM-IIR-ADEPT-ICU, 22761
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