Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Cancer Survivors

Depression Clinical Trial

Official title: Feasibility and Efficacy of a Digital Neurotherapy Protocol for Management of Depression, Cognition, and Quality of Life in Patients With Major Medical Illnesses

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

This is a randomized, waitlist-control study to evaluate the feasibility and efficacy of an 8-week DNT intervention in patients with major medical illnesses. Waitlisted subjects will be given the option of receiving the DNT after completion of the waitlist period. Subjects will not be blinded to treatment condition.

Hypothesis 1: It is hypothesized that an 8-week DNT intervention will be feasible for 2 groups of patients with major medical illnesses: 1) a group of cancer survivors, and 2) a group of patients with ESKD on dialysis.

Hypothesis 2: It is hypothesized that this intervention will decrease depression symptoms, improve quality of life, and improve attention, executive functioning, and memory.

Study Procedures

General procedure: Potential subjects will be informed of the study and their option to participate by staff and providers during routine clinic visits to the Cancer Survivorship Program at Smilow Cancer Hospital and at routine clinic visits through Yale Nephrology. Interested individuals will be contacted by a member of the research team to assess eligibility. After providing informed consent, subjects will be randomly assigned to either the DNT group or to a waiting-list control group who will then be offered 8 weeks of DNT training at the completion of the final outcome assessment.

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. The Rejuvenate program has 7 different games that together train attention, reaction inhibition, cognitive flexibility, use of categories, pattern recognition, memory, dealing with distraction, and auditory and visual perception. In each training session participants do 4 training games for 5 minutes each. Before each 5-minute game, participants are offered three games to choose from. The program keeps track of all the games they choose, and if their training becomes too unbalanced, the games they have been choosing most often are not offered among the three choices until appropriate balance is restored.

Assessment: Assessments will be conducted at 3 intervals (baseline, midpoint, endpoint) for each subject assigned to the experimental group during the 8-week experimental intervention. ;

Related Conditions & MeSH terms

• Cognition
• Depression
• Depressive Disorder
• Quality of Life

• NCT number: NCT04961047
• Study type: Interventional
• Source: Yale University
• Contact: Anushree Shirali, MD
• Phone: 877-925-3637
• Email: anushree.shirali@yale.edu
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2021
• Completion date: October 2024