An interventional study of Digital Cognitive Training and Digital Non-cognitive Training Intervention in ADHD, sponsored by McMaster University. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 52 is below the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
This is a gamified computer platform lacking cognitive training components.
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 11 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 11 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 11 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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