Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06627894
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Attenuating DEPression with Internet CBT to Slow Cognitive Decline in Older ICU SurvivorsADEPT-ICU
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Attenuating DEPression with Internet CBT to Slow Cognitive Decline in Older ICU SurvivorsADEPT-ICU
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADEPT-ICU
Brief Summary:
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 Alzheimers 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
Detailed Description:
Alzheimers disease and related dementias ADRD affect 47 million people worldwide with an annual global cost of 818 billion The risk of developing ADRD is disproportionately borne by older adults with multiple chronic conditions from underrepresented racial and ethnic groups URGs One such high risk group is older survivors of critical illness who were admitted to the intensive care units ICUs Nearly half of ICU survivors experience subjective cognitive declineSCD ie perceived decline in memory and thinking even with normal objective cognitive data With over 5 million adult ICU admissions in the US each year an intervention reducing SCD in older ICU survivors could significantly prevent or lower the incidence of ADRD Thus there is an urgent need for an inclusive randomized controlled trial RCT to rigorously test whether a novel accessible and scalable intervention can reduce SCD in a diverse cohort of older ICU survivors One potential target for such interventions is post-ICU depression which affects about one-third of ICU survivors To date there are no large scale RCTs which have rigorously tested whether depression focused psychotherapies such as cognitive behavioral therapy CBT reduce SCD in a diverse cohort of older ICU survivors with depression
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None