Recruiting

Internet CBT

Sponsor:

Indiana University

Code:

NCT06627894

Conditions

Depression

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression

Active Control

Study Details

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 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.

Conditions

Depression

Cognitive Decline

Study ID

NCT06627894

Start date

Mar 13, 2025

Status verified date

Oct, 2025

Completion date

Oct 30, 2029

Anticipated

Primary completion date

Oct 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention - Internet Cognitive-Behavioral Therapy (CBT) for Depression

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.

active comparator: Active Control - Depression Education, Symptom Monitoring, and Usual Care

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.

Interventions

Therapist-Assisted Internet Cognitive-Behavioral Therapy for Depression

Good Days Ahead (MindStreet, Inc.)

Active Control

Depression education, symptom monitoring, and standard depression care

Primary outcome measure

  • Subjective Cognitive Decline [ Time Frame: Measured at 6-month and 12-month follow-up. ]

Central Contacts and Locations

Central contacts

Locations

Eskenazi Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Babar Khan, MD, MS

317-274-9132bakhan@iu.edu

IU Health Methodist Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Babar Khan, MD, MS

317-274-9132bakhan@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Dec 17, 2025

Last verified

Oct, 2025

Keywords

  • Depression
  • Cognition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-12-17.