What side effects are associated with this type of intervention?

Common treatments for ADHD include pharmacological options like stimulants (methylphenidate, amphetamines) and non-stimulants (atomoxetine). Stimulants can cause side effects such as insomnia, decreased appetite, weight loss, increased heart rate, and potential for substance misuse. Atomoxetine may cause gastrointestinal issues, fatigue, and mood swings. Non-pharmacological treatments like CBT, DBT, and MBCT generally have fewer side effects, but may include initial increases in anxiety or emotional discomfort as patients confront challenging thoughts and behaviors. Digital therapies delivering cognitive training and behavioral interventions via mobile apps are being studied for their efficacy and may offer a side-effect profile similar to traditional non-pharmacological treatments, with the added benefit of accessibility and convenience.

What prior FDA approvals exist?

The FDA has approved Akili Interactive's EndeavorRx, a digital therapy in the form of a video game, for the treatment of children with ADHD. This approval highlights the potential of digital platforms in delivering cognitive training and behavioral interventions. In addition to digital therapies, several medications have been approved for ADHD treatment, including stimulants like methylphenidate and amphetamines, as well as non-stimulants like atomoxetine and guanfacine.

What other types of research exist?

Promising novel alternatives to mobile app digital therapies for ADHD patients include: 1) Pharmacological treatments such as atomoxetine and guanfacine extended release, which have shown efficacy and safety in recent studies. 2) Complementary and integrative health approaches like guided imagery, hypnosis, and biofeedback, which are gaining acceptance for their benefits in managing ADHD symptoms. 3) Experimental treatments such as transcranial magnetic stimulation (TMS) and deep brain stimulation (DBS), which are being explored for their potential to enhance attention and manage ADHD symptoms.

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Behavioural Intervention

Mobile Apps for ADHD

N/A

Recruiting

Led By Robert Bilder, Ph.D

Research Sponsored by Think Now Incorporated

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to use a keyboard with both hands

Participant is aged 18-50 years at time of consent

Must not have

Current DSM5 diagnosis of posttraumatic stress disorder, or Major Depressive Disorder or Major Depressive Episode via self-report or as assessed with the MINI

History of severe sleep disorder, narcolepsy, epilepsy/seizure disorder, brain tumor, stroke, TBI, severe concussion resulting in loss of consciousness and hospitalization, serious oxygen deprivation (such as following heart attack, carbon monoxide poisoning, near drowning or near suffocation), encephalitis, meningitis, or other major neurological disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (day 0) and midpoint (day 25), and baseline (day 0) and endpoint (day 50)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing smartphone apps designed to help adults with ADHD. The apps aim to improve attention and other mental skills through brain-training exercises. Participants will use the apps at home for several weeks, with assessments conducted at different stages of the treatment period.

Who is the study for?

This trial is for adults who have been diagnosed with ADHD. The specific eligibility criteria are not provided, so it's important to contact the study organizers for detailed information on who can participate.

What is being tested?

The trial is testing two mobile app digital therapies, referred to as UC-A and UC-N, to see how they affect cognitive function and symptoms in adults with ADHD.

What are the potential side effects?

Since the interventions are mobile apps designed for therapeutic purposes, side effects may be minimal but could include eye strain or headache from screen use. Specific side effects will depend on the nature of the app activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can use a keyboard with both hands.

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I am between 18 and 50 years old.

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My vision and hearing are normal, or corrected to be normal.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with PTSD or major depression.

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I have a history of severe neurological or sleep disorders.

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I have a history of chronic fatigue syndrome or Long-COVID.

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I am currently taking guanfacine or other specific medications for focus and attention.

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I am not planning to start any new medications listed as excluded during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (day 0) and midpoint (day 25), and baseline (day 0) and endpoint (day 50)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (day 0) and midpoint (day 25), and baseline (day 0) and endpoint (day 50)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 0) and midpoint (day 25), and baseline (day 0) and endpoint (day 50) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)

Secondary study objectives

Barkley Adult ADHD Rating Scale (BAARS-IV) - Inattentive Subscale (Inatt). (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)

Nelson Denny Reading Comprehension Test (NDRT) - Reading Comprehension Scaled Score (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)

Other study objectives

Adult ADHD Quality of Life Scale (AAQoL) - Productivity. (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: UC-AActive Control1 Intervention

UC-0A is a digital mobile app intervention that uses cognitive control skills for task performance. The intervention is used once a day, 5 days a week, for 7 weeks.

Group II: UC-NActive Control1 Intervention

UC-0N is a digital mobile app intervention that uses cog control skills for problem solving. The intervention is used once a day, 5 days a week, for 7 weeks.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ADHD include pharmacological and non-pharmacological approaches. Stimulant medications like methylphenidate and amphetamines increase dopamine and norepinephrine levels in the brain, improving attention and reducing impulsivity and hyperactivity. Non-pharmacological treatments, such as cognitive-behavioral therapy (CBT), mindfulness-based cognitive therapy (MBCT), and cognitive training, focus on enhancing executive function, improving self-regulation, and teaching skills to manage behavior and thoughts. These mechanisms are important for ADHD patients as they help tailor treatment plans to individual needs, improving overall symptom management and quality of life.

Twenty years of research on attention-deficit/hyperactivity disorder (ADHD): looking back, looking forward.