Evaluating a Digital Cognitive Training Intervention in Adults With ADHD

NCT ID: NCT07050225

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-02-28

Brief Summary

The goal of this clinical trial is to evaluate whether a digital cognitive training program can reduce symptoms of ADHD, improve executive functioning, and decrease problematic internet use in adults aged 18-65 with a diagnosis of moderate to severe ADHD. The main questions it aims to answer are:

Can digital cognitive training improve executive function, and ADHD symptoms in adults with ADHD?

Does digital cognitive training reduce problematic internet use in this population?

Researchers will compare the digital cognitive training intervention group to a non-cognitive training digital platform to see if the training leads to greater improvements in cognitive and behavioral outcomes.

Participants will:

Complete an 11-week digital cognitive training program (3, 1-hour sessions/week) or placebo intervention (3, 1-hour sessions/week)

Attend baseline, midpoint, and post-intervention assessments

Participate in weekly check-ins to monitor engagement and tolerability

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Digital Cognitive Training

Participants randomized to the intervention group will receive 1-hour cognitive training sessions three times weekly for 10 weeks. The digital cognitive training platform will consist of personalized gamified cognitive tasks that target individual cognitive deficits associated with ADHD including attention, impulsivity, working memory, and cognitive flexibility.

Group Type: EXPERIMENTAL

Digital Cognitive Training

Intervention Type: OTHER

This digital cognitive training program uses gamified tasks in order to enhance cognitive skills in an engaging manner using machine learning AI algorithms to target the intervention to individual cognitive skill deficits. It consists of personalized gamified cognitive tasks that target individual cognitive deficits associated with ADHD including attention, impulsivity, working memory, and cognitive flexibility.

Digital Non-cognitive Training Intervention

Participants will use a control gamified computer platform matched for time but lacking cognitive training components. Participants will engage in this activity for 1 hour three times a week for a duration of 10 weeks.

Group Type: PLACEBO_COMPARATOR

Digital Non-cognitive Training Intervention

Intervention Type: OTHER

This is a gamified computer platform lacking cognitive training components.

Interventions

Digital Cognitive Training

This digital cognitive training program uses gamified tasks in order to enhance cognitive skills in an engaging manner using machine learning AI algorithms to target the intervention to individual cognitive skill deficits. It consists of personalized gamified cognitive tasks that target individual cognitive deficits associated with ADHD including attention, impulsivity, working memory, and cognitive flexibility.

Intervention Type: OTHER

Digital Non-cognitive Training Intervention

This is a gamified computer platform lacking cognitive training components.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Participants must provide informed consent and agree to comply with study protocols for the duration of the study.
• Participants must be fluent in speaking and reading English and able to complete rating scales and assessments.
• Participants must be adults aged 18-65 years.
• Participants must have a clinical diagnosis of ADHD based on DSM-5 Criteria, as confirmed by the Mini Neuropsychiatric interview.
• Participants being treated with pharmacotherapy must be stable and on a consistent dose for at least 6 weeks prior to study entry.
• Participants must have access to a computer capable of running the cognitive training platform.
• Participants must be comfortable operating a computer and be able to log on to the platform without assistance.

Exclusion Criteria

• Exclude individuals who meet DSM-5 criteria for psychiatric conditions such as borderline personality disorder, schizophrenia, severe depression, or other psychotic disorders as well as neurological conditions such as epilepsy, dementia, and amnesia, that may interfere with cognitive training.
• Exclude participants with active substance use disorders.
• Exclude participants receiving behavioral therapy or undergoing similar cognitive training programs for ADHD and/or PIU.
• Exclude individuals with severe visual, auditory, or motor impairments that affect the ability to perform the digital cognitive training intervention.
• Exclude participants who are uncomfortable using applications or required technology.
• Exclude participants who have changed their treatment regimen in the last 6 weeks.
• Exclude participants who are not fluent in English.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

DCOG_ADHD

Identifier Type: -

Identifier Source: org_study_id