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Behavioral Intervention
Digital Therapeutics for Depression
N/A
Waitlist Available
Led By Lauren Oberlin, PhD
Research Sponsored by AdventHealth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, mid-treatment (week 2), and post-treatment (week 4)
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a digital brain training program for older adults with depression-related apathy. The program is expected to improve brain connections and reduce apathy symptoms by enhancing cognitive control.
Who is the study for?
This trial is for people over 60 with major depressive disorder and significant apathy, but no psychotic features. They must have a certain level of depression severity, be stable on antidepressants or other psychotropic meds for at least 8 weeks, and not plan to change doses soon. Participants need computer access, can follow instructions in English, are able to undergo MRI scans (no metal implants), and aren't at suicide risk or have serious medical/neurological conditions.
What is being tested?
The study tests whether a custom digital cognitive training program can improve brain function related to apathy in older adults with depression. Over four weeks, participants will use this program aiming to reduce symptoms of apathy as well as enhance cognitive control performance.
What are the potential side effects?
Since the interventions involve non-invasive digital cognitive exercises rather than medication or invasive procedures, side effects may include eye strain or headache from screen time; however specific side effects are not detailed in the provided information.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, mid-treatment (week 2), and post-treatment (week 4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, mid-treatment (week 2), and post-treatment (week 4)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Resting State Functional Connectivity among the Salience, Executive Control, and Reward Networks
Secondary study objectives
Change in Apathy Evaluation Scale (AES) score
Change in Stroop Interference score
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: Targeted Cognitive Training InterventionExperimental Treatment1 Intervention
Group II: General Cognitive Training InterventionActive Control1 Intervention
Find a Location
Who is running the clinical trial?
AdventHealthLead Sponsor
115 Previous Clinical Trials
31,281 Total Patients Enrolled
National Institute of Mental Health (NIMH)NIH
2,910 Previous Clinical Trials
2,738,926 Total Patients Enrolled
1 Trials studying Apathy
22 Patients Enrolled for Apathy
Weill Medical College of Cornell UniversityLead Sponsor
1,084 Previous Clinical Trials
1,138,794 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had electroconvulsive therapy in the last year.I can sign and understand the consent form for the study.I am currently in a cognitive rehabilitation program.I've been on a stable dose of antidepressants for 8 weeks and don't plan to change it.I am 60 years old or older.I have or had a serious brain or nerve condition like Alzheimer's, MS, or epilepsy.I have been on a stable dose of my mental health medication for at least 8 weeks.I am not taking any psychoactive drugs that could affect the study, except for antidepressants or benzodiazepines.I have been diagnosed with major depression without psychosis.I do not have any severe health conditions that could affect my participation in the study.I will not travel for 2+ weeks in a row during the study, preventing MRI data collection.
Research Study Groups:
This trial has the following groups:- Group 1: Targeted Cognitive Training Intervention
- Group 2: General Cognitive Training Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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