Digital Therapeutics for Depression

Recruiting at 3 trial locations

Overseen By Lauren Oberlin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: AdventHealth

Must be taking: Antidepressants, Psychotropics

Must not be taking: Cholinesterase inhibitors, Antipsychotics

Disqualifiers: Neurologic disorders, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital cognitive training program to determine its effectiveness in reducing apathy (lack of interest or concern) in individuals with late-life depression. Participants will use a targeted digital tool designed to improve brain connections and boost overall mental function. The trial seeks individuals aged 60 and older who have been diagnosed with depression and experience significant apathy. Those who have been stable on their current antidepressant for at least eight weeks and have access to a computer or tablet with Wi-Fi may find this trial suitable. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance mental health treatments for others.

Will I have to stop taking my current medications?

The trial requires that you either be off antidepressants or on a stable dose for at least 8 weeks, and you should not plan to change the dose in the next 5 weeks. You also need to be on a stable dose of other psychotropic medications for at least 8 weeks. If you are taking other psychoactive drugs, you may need to stop if they could affect the study data.

What prior data suggests that this digital cognitive training intervention is safe for treating depression?

Research has shown that digital brain training is generally safe for adults, including those with major depression. One study found that a digital tool called AKL-T03 was safe and helped with cognitive issues related to major depression. Another study demonstrated that a video game-like program improved brain function and mood in middle-aged and older adults with major depressive disorder (MDD). These findings suggest that digital brain training programs are well-tolerated and have not raised any serious safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a fresh approach to tackling depression by using digital cognitive training. Unlike traditional antidepressants or therapy sessions, the Targeted Cognitive Training Intervention focuses on enhancing specific cognitive functions through digital exercises, potentially providing a more personalized and engaging way to manage depression. This method could complement existing treatments, offering a non-invasive and accessible option that can be tailored to individual needs. By leveraging technology, it might also provide immediate feedback and progress tracking, which could enhance motivation and adherence to the therapy.

What evidence suggests that this trial's treatments could be effective for depression?

Research shows that specific brain exercises can improve thinking skills in people with depression. Several studies have found that these exercises can ease daily life and reduce depression symptoms. In this trial, participants will join one of two treatment arms: the Targeted Cognitive Training Intervention or the General Cognitive Training Intervention. One study found that people improved their ability to remember words after brain training. Another study reported that participants felt less depressed and had more positive thoughts after completing online brain exercises. While results can differ, these findings suggest that targeted brain exercises might help treat lack of motivation and thinking problems in older adults with depression. ^{6 7 8 9 10}

Who Is on the Research Team?

Lauren Oberlin, PhD

Principal Investigator

AdventHealth

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

DRS total score > 129 or DRS scaled score of 5 based on age and education-adjusted normative data

I can sign and understand the consent form for the study.

Montgomery-Åsberg Depression Rating Scale (MADRS) score > or = 16

Exclusion Criteria

I have not had electroconvulsive therapy in the last year.

Color Blindness

I am currently in a cognitive rehabilitation program.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 4-week customized digital cognitive training program to target brain function in apathy of late-life depression

4 weeks

Baseline, Mid-treatment (Week 2), and Post-treatment (Week 4)

Follow-up

Participants are monitored for changes in brain connectivity, apathy severity, and cognitive control performance after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• General Cognitive Training Intervention
• Targeted Cognitive Training Intervention

Trial Overview

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.

How Is the Trial Designed?

Group I: Targeted Cognitive Training Intervention Experimental Treatment 1 Intervention

Group II: General Cognitive Training Intervention Active Control 1 Intervention

Who Is Running the Clinical Trial?

AdventHealth

Lead Sponsor

Trials

118

Recruited

31,800+

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

Digital interventions for depression have a significant medium effect size (g = .52) compared to control conditions, based on a systematic review of 83 studies involving 15,530 participants.

Interventions with human therapeutic guidance are more effective (g = .63) than self-help interventions (g = .34), and there is no significant difference in outcomes between digital interventions and traditional face-to-face therapy, suggesting that digital options can be a viable alternative for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital interventions for the treatment of depression: A meta-analytic review. Moshe, I., Terhorst, Y., Philippi, P., et al.[2021]

In a study involving 46 young adults with mild depressive symptoms, executive functioning and processing speed (EF/PS)-focused computerized cognitive training (CCT) led to greater improvements in those specific cognitive areas compared to verbal ability-focused CCT.

Both types of CCT resulted in significant improvements in mood and everyday functioning, but the EF/PS group achieved similar mood benefits with only half the training time, suggesting that the content of CCT may not be as crucial as the engagement in the training itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. Motter, JN., Grinberg, A., Lieberman, DH., et al.[2019]

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