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

220 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized clinical study to evaluate the feasibility and efficacy of a digital neurotherapy on depression, cognition, and quality of life in two groups of patients with major medical illness: 1) a sample of cancer survivors, and 2) a sample of patients with end stage kidney disease (ESKD) on dialysis.

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 data supports the effectiveness of the Digital Neurotherapy treatment for depression and cognitive improvement in cancer survivors?

Research shows that internet-delivered cognitive behavioral therapy (iCBT) can effectively reduce depression and anxiety in cancer survivors, suggesting that digital therapies like Digital Neurotherapy might also be beneficial. ^{1 2 3 4 5}

How is Digital Neurotherapy (DNT) Treatment different from other treatments for depression and cognitive issues in cancer survivors?

Digital Neurotherapy (DNT) is unique because it likely involves a digital or technology-based approach to address depression and cognitive issues, which may differ from traditional drug therapies or cognitive-behavioral therapy. This approach could offer a non-invasive and personalized treatment option, potentially using digital tools to target specific cognitive changes associated with cancer treatment. ^{5 6 7 8 9}

Research Team

Anushree Shirali, MD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England 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). [2020]

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

Evaluating an engaging and coach-assisted online cognitive behavioral therapy for depression among adolescent and young adult cancer survivors: A pilot feasibility trial. [2023]

3. Germany 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. [2018]

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

Making Internet-delivered cognitive behaviour therapy scalable for cancer survivors: a randomized non-inferiority trial of self-guided and technician-guided therapy. [2021]

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

Cancer-related depression: Part I--Neurologic alterations and cognitive-behavioral therapy. [2018]

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

Neuroimaging biomarkers and cognitive function in non-CNS cancer and its treatment: current status and recommendations for future research. [2021]

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

Emerging pharmacotherapy for cancer patients with cognitive dysfunction. [2022]

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

Longitudinal Analysis of Depression and Anxiety Symptoms as Independent Predictors of Neurocognitive Function in Primary Brain Tumor Patients. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluating cognitive complaints in breast cancer survivors with the FACT-Cog and quantitative electroencephalography. [2018]