DepressionADEPT-ICUNCT06627894
Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
A study testing Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression in people with Depression and Cognitive Decline, run by Indiana University at 2 sites in United States.
Trial 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 Alzheimer's disease and related dementias (ADRD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Depression, Cognitive Decline
- What is being tested?
- Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Mar 2025to 30 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50 years of age and older
- Admitted to the intensive care for greater > 48 hours
- Able to understand and provide informed consent
- 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)
- Willing to participate in cognitive testing
- Access to a telephone
- Discharge to home or an independent or assisted living facility
- 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.
Who cannot join
- 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
- Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
- Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
- Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
- Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
- Ischemic or hemorrhagic stroke, traumatic brain injury, or undergoing neurosurgery prior, during or after ICU stay
Show all 9Show fewer
- Uncorrected visual or auditory impairment including legal blindness or deaf
- Status post tracheostomy and not able to communicate
- Incarcerated or on parole after ICU stay
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Eskenazi Hospital
Indianapolis, Indiana, 46202
Babar Khan, MD, MS, 317-274-9132, bakhan@iu.edu
- Recruiting
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
Babar Khan, MD, MS, 317-274-9132, bakhan@iu.edu
About 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.
Read the detailed description
Alzheimer's 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 decline(SCD), i.e., 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.
- Conditions
- Depression, Cognitive Decline
- Being tested
- Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression, Active Control
- Keywords
- Depression, Cognition
- Medical subject headings
- Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapist-Assisted Internet Cognitive-Behavioral Therapy for DepressionBehavioural
Good Days Ahead (MindStreet, Inc.)
Active ControlBehavioural
Depression education, symptom monitoring, and standard depression care
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression | Experimental | Participants will complete nine 45-minute sessions of an internet CBT for depression called Good Days Ahead (GDA; MindStreet, Inc.) with 20 minutes of therapist assistance per session on the phone over six months. Receives: Behavioral: Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression |
| Active Control - Depression Education, Symptom Monitoring, and Usual Care | Active comparator | Participants will review nine 45-minute segments of depression education material on their own with 20 minutes of therapist assistance per segment on the phone over six months. They will also have access to and could receive current depression care in the targeted healthcare systems. Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Cognitive Decline
The primary outcome will be subjective cognitive decline (SCD), measured using the Cognitive Change Index self-report version (CCI-SR).
Measured: Measured at 6-month and 12-month follow-up.
Secondary outcomes (2)
Cognition status
Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Measured: Measured at 6-month and 12-month follow-up.
Quality of Life physical and mental component status
Medical Outcome Study Short Form (SF-36)
Measured: Measured at 6-month and 12-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study start13 Mar 2025
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Internet based CBT-D vs Active Control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Babar Khan, MD, MS, Indiana University
- Investigators
- Babar Khan, MD, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06627894
- Sponsor's protocol ID
- 22761
- Other IDs
- 1R01AG084754-01A1
- Acronym
- ADEPT-ICU
- Status last verified
- Oct 2025
- First submitted
- 3 Oct 2024
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Attenuating DEPression With Internet CBT to Slow Cognitive Decline in Older ICU Survivors(ADEPT-ICU)
- ClinicalTrials.gov ID
- NCT06627894
- Acronym / sponsor ID
- ADEPT-ICU / 22761
- Conditions
- Depression, Cognitive Decline
- Keywords
- Depression, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 13 Mar 2025 (actual)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 4 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alzheimer's 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 decline(SCD), i.e., 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Internet based CBT-D vs Active Control
| Arm | Type | Receives |
|---|---|---|
| Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression | Experimental | Behavioral: Therapist-Assisted Internet Cognitive-Behavioral Therapy for DepressionParticipants will complete nine 45-minute sessions of an internet CBT for depression called Good Days Ahead (GDA; MindStreet, Inc.) with 20 minutes of therapist assistance per session on the phone over six months. |
| Active Control - Depression Education, Symptom Monitoring, and Usual Care | Active comparator | Behavioral: Active ControlParticipants will review nine 45-minute segments of depression education material on their own with 20 minutes of therapist assistance per segment on the phone over six months. They will also have access to and could receive current depression care in the targeted healthcare systems. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 50 years of age and older
- Admitted to the intensive care for greater > 48 hours
- Able to understand and provide informed consent
- 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)
- Willing to participate in cognitive testing
Key exclusion criteria (9 listed)
- 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
- Diagnosis of severe mental illness (bipolar disorder, schizophrenia, schizoaffective) as per EHR and screening questions
- Persistent psychotic symptoms after ICU stay which would interfere with successful completion of intervention
- Recent or recurrent alcohol or substance use disorder as per HER and Drug Abuse Screening Test
- Life expectancy less than 1 year (e.g. terminal cancer diagnosis, discharged on hospice)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapist-Assisted Internet Cognitive-Behavioral Therapy for DepressionGood Days Ahead (MindStreet, Inc.) | Behavioural | Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression |
| Active ControlDepression education, symptom monitoring, and standard depression care | Behavioural | Active Control - Depression Education, Symptom Monitoring, and Usual Care |
Primary outcome
Subjective Cognitive Decline
Time frame: Measured at 6-month and 12-month follow-up.
The primary outcome will be subjective cognitive decline (SCD), measured using the Cognitive Change Index self-report version (CCI-SR).
2 secondary outcomes
Cognition status
Time frame: Measured at 6-month and 12-month follow-up.
Quality of Life physical and mental component status
Time frame: Measured at 6-month and 12-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Babar Khan, MD, MS principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression in people with Depression and Cognitive Decline, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Babar Khan, MD, MS (317-274-9132, bakhan@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Cognitive Decline (time frame: Measured at 6-month and 12-month follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.