Evaluating a Digital Cognitive Training Intervention in Adults With ADHD

Evaluating the Feasibility and Tolerability of a Digital Cognitive Training Intervention in Adults With ADHD: A Randomized, Placebo-controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: ADHD
• Intervention / Treatment: Other: Digital Cognitive Training; Other: Digital Non-cognitive Training Intervention

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Placebo Comparator: 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.	Other: Digital Non-cognitive Training Intervention; This is a gamified computer platform lacking cognitive training components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who prematurely withdraw from the study protocol	Tolerability of the digital cognitive training intervention will be assessed by calculating the number of participants who discontinue participation before completing the full 11-week study protocol. Premature withdrawal will be defined as any participant who discontinues the intervention and/or does not complete post-treatment assessments.	From enrollment to the end of treatment at 11 weeks
The feasibility of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity	Feasibility will be evaluated based on the number of people who contact the study team, percent of people who contact who are eligible, and percent of eligible participants who enroll. Percent of participants lost to follow-up will be a key determinant of feasibility, as well as number of completers.	From enrollment to the end of treatment at 11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effects of digital cognitive training on problematic internet use in adults diagnosed with ADHD of moderate-severe severity	Changes in the severity of problematic internet use will be evaluated via changes in Compulsive Internet Use Scale (CIUS) scores.	From enrollment to the end of treatment at 11 weeks
The effects of digital cognitive training on visual processing and working memory in adults diagnosed with ADHD of moderate-severe severity	Performance on Trails A and B task will be evaluated.	From enrollment to the end of treatment at 11 weeks
The effects of digital cognitive training on cognitive flexibility in adults diagnosed with ADHD of moderate-severe severity	Performance on Berg's Card Sorting Task will be evaluated.	From enrollment to the end of treatment at 11 weeks
The effects of digital cognitive training on working memory in adults diagnosed with ADHD of moderate-severe severity	Performance on N-back Task will be evaluated.	From enrollment to the end of treatment at 11 weeks
The effects of digital cognitive training on verbal short-term and working memory in adults diagnosed with ADHD of moderate-severe severity	Performance on the Digit Span Test will be evaluated.	From enrollment to the end of treatment at 11 weeks
The effect of digital cognitive training on ADHD symptoms in adults diagnosed with ADHD of moderate-severe severity	ADHD symptom severity will be measured via the Barkley Adult ADHD Rating Scale (BAARS-IV). The minimum score on the Barkley ADHD Rating Scale is 0, and the maximum score is 54. The scale consists of 18 items, each rated on a scale of 0 to 3, where 0 indicates the absence of the symptom and 3 indicates a high level of severity.	From enrollment to the end of treatment at 11 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes on symptoms of anxiety	The Generalized Anxiety Disorder 7-item (GAD-7), a 7-item questionnaire will be used to screen for the severity of symptoms of anxiety. The Generalized Anxiety Disorder 7-item (GAD-7) scale has a minimum score of 0 and a maximum score of 21. The scale uses a 4-point Likert scale for each of its 7 items, ranging from 0 ("Not at all") to 3 ("Nearly every day"). Higher scores indicate more severe anxiety symptoms.	From enrollment to the end of treatment at 11 weeks
Changes on symptoms of depression	The Patient Health Questionnaire (PHQ)-9, the major depressive disorder (MDD) module of the full PHQ will be used to measure the severity of depressive symptoms. The PHQ-9 is a widely used tool for assessing depression severity. The minimum possible score on the PHQ-9 is 0, and the maximum is 27. Each of the 9 questions is scored from 0 to 3, with higher scores indicating more severe symptoms.	From enrollment to the end of treatment at 11 weeks
Changes in quality of life	World Health Organization Quality of Life Brief Version (WHOQOL-BREF) will be used to assess impairment and quality of life. The WHOQOL-BREF (World Health Organization Quality of Life Brief Version) is scored on a 1-5 scale for each of the 26 items. These scores are then transformed to a 0-100 scale. The minimum possible score for each domain is 0, representing the worst possible quality of life, and the maximum is 100, representing the best possible quality of life.	From enrollment to the end of treatment at 11 weeks

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: June 6, 2025
• First Submitted That Met QC Criteria: June 24, 2025
• First Posted (Actual): July 3, 2025

Study Record Updates

• Last Update Posted (Actual): July 22, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Executive Functioning; ADHD; Attention Deficit Hyperactivity Disorder; Attention; Digital Health; Hyperactivity; Adult ADHD; Problematic Internet Use; Cognitive Training Intervention; Adjunct Therapy; PIU; ADHD Symptoms
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: DCOG_ADHD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No