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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment General Cognitive Training Intervention and Targeted Cognitive Training Intervention for depression?

Research shows that computerized cognitive training can improve mood and cognitive functions like attention and memory in people with depression. Studies have found that engaging in these cognitive exercises can lead to better cognitive performance and may help manage depressive symptoms. ^{1 2 3 4 5}

Is digital cognitive training safe for humans?

The studies reviewed did not report any safety concerns related to digital cognitive training interventions for depression, suggesting they are generally safe for human use. ^{5 6 7 8 9}

How does the Targeted Cognitive Training Intervention treatment for depression differ from other treatments?

The Targeted Cognitive Training Intervention is unique because it uses digital tools to enhance cognitive control over emotional information processing, often incorporating gamification to improve motivation and engagement. Unlike traditional therapies, it focuses on improving cognitive functions like attention and memory, which are often impaired in depression, through structured, computerized exercises. ^{1 2 3 5 7}

Research Team

Lauren Oberlin, PhD

Principal Investigator

AdventHealth

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Cognitive remediation for treatment-resistant depression: effects on cognition and functioning and the role of online homework. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Gamification improves antidepressant effects of cognitive control training-A pilot trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Computerized cognitive training in young adults with depressive symptoms: Effects on mood, cognition, and everyday functioning. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Improvement in self-reported cognitive functioning but not in rumination following online working memory training in a two-year follow-up study of remitted major depressive disorder. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Online neurocognitive remediation therapy to improve cognition in community-living individuals with a history of depression: A pilot study. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Digital interventions for common mental disorders in low- and middle-income countries: A systematic review and meta-analysis. [2023]

7. England pubmed.ncbi.nlm.nih.gov

A randomized, controlled pilot trial of the Emotional Faces Memory Task: a digital therapeutic for depression. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of depressed mood on objective and subjective measures of attention. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Digital interventions for the treatment of depression: A meta-analytic review. [2021]