Digital Neurotherapy for Depression and Cognitive Improvement in Cancer Survivors

Overseen By Lauren Liberti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Stage 4 cancer, Brain cancer, Psychosis, Dementia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital neurotherapy to determine its effectiveness in improving depression, thinking skills, and quality of life for individuals with major health issues. Participants use a brain training program on a tablet or computer for a short time each week. The trial seeks cancer survivors who have undergone treatments like chemotherapy or radiation, as well as individuals with end-stage kidney disease receiving dialysis. Interested participants should be able to use a computer and have no severe mental illnesses or sensory issues that would hinder participation. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this digital neurotherapy is safe for cancer survivors and patients with end stage kidney disease?

Studies have shown that digital therapies, like the digital neurotherapy (DNT) being tested, are generally easy to use and well-received. Research indicates that similar digital therapies, such as digital cognitive-behavioral therapy, have been positively received by cancer survivors. These therapies are engaging and user-friendly.

Digital neurotherapies do not involve medication, so they usually have fewer side effects compared to drug treatments. Reports of serious unexpected medical problems with these digital therapies are rare. This makes them a promising and safe option for managing symptoms like depression and cognitive issues in people with major medical conditions.

For those considering joining a trial with digital neurotherapy, existing evidence suggests it is a safe choice with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Digital Neurotherapy (DNT) is unique because it offers a non-invasive, digital approach to addressing depression and cognitive issues in cancer survivors, unlike traditional methods that might involve medication or talk therapy. This treatment involves interactive brain training exercises delivered right in the participant's home using their tablet or computer. Researchers are excited about DNT because it promises to improve mental health conveniently and potentially with fewer side effects, allowing patients to engage in therapy without the need to travel or adhere to clinic schedules.

What evidence suggests that digital neurotherapy is effective for depression and cognitive improvement in cancer survivors?

Research has shown that digital neurotherapy (DNT), which participants in this trial may receive, can help cancer survivors enhance their cognitive and emotional well-being. One study found that this therapy improved mental, physical, and emotional health, as well as overall quality of life. Another review indicated that online brain exercises helped cancer survivors feel better emotionally and think more clearly. Additionally, some cancer survivors using neurofeedback, a similar brain training method, reported fewer issues like fatigue and cognitive difficulties. These findings suggest that DNT could be beneficial for addressing depression and cognitive challenges in cancer survivors. Participants in the waitlist control group will receive DNT training after the final outcome assessment. ^{1 4 6 7 8}

Who Is on the Research Team?

Anushree Shirali, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for adult cancer survivors from Smilow Cancer Hospital who have undergone chemotherapy, radiation, or immunotherapy. Participants must understand English and be willing to follow the study's procedures. Those with serious mental illness, cognitive impairment, severe hearing or vision issues, stage 4 cancer, or brain cancer cannot join.

Inclusion Criteria

You are willing to comply with all study procedures and are available for the duration of the study.

Provision of signed and date informed consent form.

You are able to understand and read English.

Exclusion Criteria

You have been diagnosed with a serious mental illness such as psychosis.

You have been diagnosed with a cognitive impairment, such as dementia or intellectual disability.

My hearing and vision allow me to do computer exercises.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Treatment

Participants receive 8 weeks of digital neurotherapy (DNT) 4 times a week for 30 minutes at home using the Rejuvenate brain training program

8 weeks

Home-based sessions

Follow-up

Participants are monitored for changes in depression, cognition, and quality of life through assessments conducted at baseline, midpoint, and endpoint

8 weeks

Waitlist Control

Participants in the waitlist control group are offered 8 weeks of DNT training after the final outcome assessment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Neurotherapy (DNT) Treatment
• Wait list control group

Trial Overview The study is testing a digital neurotherapy (DNT) treatment aimed at improving depression symptoms, cognition, and quality of life in cancer survivors. It's a randomized trial where participants are either placed in the DNT group or put on a wait list as a control.

How Is the Trial Designed?

Group I: Digital neurotherapy (DNT) Treatment Experimental Treatment 1 Intervention

The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program

Group II: Wait list control group Active Control 1 Intervention

Waiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Published Research Related to This Trial

An eight-lesson internet-delivered CBT program for anxiety and depression in early-stage cancer patients received high acceptability from participants, indicating it is user-friendly and engaging.

Participants supported the idea of combining resources for anxiety and depression, but suggested that a separate course should be developed for those with advanced-stage cancer, highlighting the need for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an internet cognitive behavioural therapy program for people with early-stage cancer and cancer survivors with depression and/or anxiety: thematic findings from focus groups. Karageorge, A., Murphy, MJ., Newby, JM., et al.[2018]

Neuroimaging techniques, such as MRI and PET, reveal that structural and functional changes in the brain are associated with cognitive impairments in patients undergoing treatment for non-CNS cancers, particularly those receiving chemotherapy.

There is a need for larger, multicenter studies and a standardized approach to better understand cognitive changes and develop targeted interventions, which could lead to personalized treatment strategies for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroimaging biomarkers and cognitive function in non-CNS cancer and its treatment: current status and recommendations for future research. Saykin, AJ., de Ruiter, MB., McDonald, BC., et al.[2021]

In a study of 114 cancer survivors, internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of anxiety and depression compared to treatment-as-usual, with a large effect size (Hedges g = 1.51).

Participants in the iCBT group also experienced lower general distress, reduced fear of cancer recurrence, and improved quality of life, indicating that this therapy is an effective and efficient option for managing mental health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). Murphy, MJ., Newby, JM., Butow, P., et al.[2020]

Cancer treatments, particularly chemotherapy and radiotherapy, can lead to cognitive dysfunction due to their cytotoxic effects, which may impair neurogenesis and affect memory and mood.

Several emerging pharmacotherapies, including stimulants like modafinil and methylphenidate, as well as anti-Alzheimer's drugs like memantine and donepezil, are being investigated to help alleviate cognitive dysfunction in cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emerging pharmacotherapy for cancer patients with cognitive dysfunction. Davis, J., Ahlberg, FM., Berk, M., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04961047

Feasibility and Efficacy of a Digital Neurotherapy Protocol ... This is a prospective, randomized clinical study to evaluate the feasibility and efficacy of a digital neurotherapy on depression, cognition, and quality of ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/record/NCT04961047?cntry=US

Feasibility and Efficacy of a Digital Neurotherapy Protocol ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10049401/

Effectiveness of a Computerized Home-Based Cognitive ... Cognitive, physical, and emotional improvements were observed, along with decreased interference in daily life activities and a better overall quality of life.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000589

Web-based cognitive interventions on subjective ... This review demonstrated that web-based cognitive interventions optimized SCI and overall psychosocial and emotional statuses for the cancer survivors.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6287382/

Exploring the Use of Neurofeedback by Cancer Survivors [15] Results revealed some cancer survivors are using neurofeedback to reduce or eliminate persistent symptoms such as fatigue, cognitive impairment, sleep ...

6. withpower.com withpower.com/trial/phase-depression-4-2025-1e657

Behavioral Activation Therapy for Cancer Survivors with ... Research shows that behavioral activation therapy can lead to significant improvements in depression symptoms for cancer patients, with many experiencing sudden ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12334484/

a qualitative study of cancer survivor' coping strategies This study highlights important strategies for cancer survivors to cope with cognitive impairments such as challenging the brain through ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12103371/

Cancer survivors' acceptability and perspectives on ... Results suggest digital CBT-I is well-accepted among cancer survivors. Digital CBT-I offers opportunities for treatment engagement.