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Behavioral Intervention

Internet Cognitive Behavioral Therapy for Depression (ADEPT-ICU Trial)

N/A
Waitlist Available
Led By Babar Khan, MD, MS
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
50 years of age and older
Admitted to the intensive care for greater than 48 hours
Must not have
Uncorrected visual or auditory impairment including legal blindness or deaf
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured at 6-month and 12-month follow-up.
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test an internet-based therapy program called Good Days Ahead (GDA) to help older intensive care unit (ICU) survivors who are experiencing depression and cognitive decline. The goal is

Who is the study for?
This trial is for older individuals who survived an ICU stay and are experiencing moderate to severe depression, which may contribute to cognitive decline. The goal is to see if treating depression can slow down memory and thinking problems that sometimes lead to dementia.
What is being tested?
The ADEPT-ICU study compares two groups: one receives Internet Cognitive-Behavioral Therapy (CBT) specifically designed for depression called Good Days Ahead (GDA), while the other group participates in a control activity not specified here.
What are the potential side effects?
Internet CBT like GDA typically doesn't have physical side effects but can sometimes cause emotional discomfort as participants work through personal issues related to their depression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 50 years old or older.
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I have been in the ICU for more than 48 hours.
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I understand the study and can give my consent.
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I will be discharged to my home or a facility where I can live with some assistance.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe vision or hearing loss that hasn't been corrected.
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I was diagnosed with a neurodegenerative disease like Alzheimer's before my ICU stay.
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I have had a stroke, brain injury, or brain surgery before, during, or after an ICU stay.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured at 6-month and 12-month follow-up.
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at 6-month and 12-month follow-up. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Subjective Cognitive Decline
Secondary study objectives
Cognition status
Quality of Life physical and mental component status

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Internet Cognitive-Behavioral Therapy (CBT) for DepressionExperimental Treatment1 Intervention
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.
Group II: Active Control - Depression Education, Symptom Monitoring, and Usual CareActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,045 Previous Clinical Trials
1,316,584 Total Patients Enrolled
32 Trials studying Depression
11,584 Patients Enrolled for Depression
National Institute on Aging (NIA)NIH
1,804 Previous Clinical Trials
28,194,599 Total Patients Enrolled
40 Trials studying Depression
31,666 Patients Enrolled for Depression
Babar Khan, MD, MSPrincipal InvestigatorIndiana University
1 Previous Clinical Trials
160 Total Patients Enrolled
~200 spots leftby Oct 2029