Guided ADHD Therapy for ADHD

(GAMES Trial)

No longer recruiting at 14 trial locations

Overseen By Bob Schafer, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Lumos Labs, Inc.

Must not be taking: Non-stimulants, Psychoactive drugs

Disqualifiers: PTSD, Bipolar, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new at-home, game-based digital therapy for adults with Attention-Deficit/Hyperactivity Disorder (ADHD). Researchers aim to determine if this digital therapy is safe and effective in treating ADHD symptoms. Participants will use either this new ADHD therapy or a different control therapy for comparison. This trial may suit adults diagnosed with ADHD who are not currently taking stimulant medications and can regularly connect to the internet. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future ADHD treatments.

Will I have to stop taking my current medications?

If you are currently taking medications like methylphenidate or amphetamine for ADHD, you may need to stop them if you and the study doctor agree it's appropriate. If you're on non-stimulant ADHD medications, you cannot participate in the trial.

What prior data suggests that this digital therapy is safe for treating ADHD?

Research has shown that digital therapy for ADHD is under study to assess its safety and effectiveness. One study with children evaluated the safety of digital therapy, and the results suggested it was well-tolerated, with most children experiencing no serious side effects. Although this study focused on children, it suggests that digital therapy might also be safe for adults.

It is important to note that this trial is at a stage where all safety details might not yet be available. However, the ongoing testing of this therapy indicates researchers' optimism about its safety. Considering participation in this trial is a positive sign that digital therapies for ADHD are being carefully studied for both safety and effectiveness. Always consult a healthcare provider with any questions or concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Guided ADHD Therapy because it offers a personalized approach to managing ADHD symptoms, which differs from standard treatments like medication and traditional behavior therapy. Unlike the standard care that often focuses on a one-size-fits-all strategy, this therapy tailors interventions based on individual needs, potentially improving effectiveness and patient engagement. The method emphasizes guided sessions that adapt to the specific challenges of each person with ADHD, fostering a more interactive and responsive treatment experience.

What evidence suggests that this game-based digital therapy is effective for ADHD?

Research shows that digital therapies can help manage ADHD symptoms. In this trial, participants will receive either ADHD Therapy or Control Therapy. One study found that digital treatments reduced inattention and hyperactivity/impulsivity in people with ADHD. Another study on cognitive behavioral therapy (CBT) for adults with ADHD found that 31% of participants improved by at least 20% on a self-report scale. Digital therapy has also shown effectiveness for children with ADHD, demonstrating positive results in managing symptoms. These findings suggest that digital and game-based therapies might offer a promising way to treat ADHD at home. ^{4 6 7 8 9}

Who Is on the Research Team?

Ann Childress, MD

Principal Investigator

Clinical Research of Southern Nevada, LLC

Are You a Good Fit for This Trial?

Adults aged 22-55 with ADHD, an IQ score of at least 80, and a clinician-rated ADHD-RS total score ≥28 can join. They must speak English, not be on certain ADHD medications or agree to stop them if they are, and have daily access to a wireless network. People with severe psychiatric disorders, recent substance abuse, motor conditions that prevent game playing, or who've used similar digital therapies recently cannot participate.

Inclusion Criteria

I am either male or female.

Ability to comply with all the testing and study requirements

I have been diagnosed with ADHD, either combined or inattentive type, by a trained clinician.

Exclusion Criteria

You are not allowed to use certain drugs that affect your brain and behavior during the study, unless they are specifically prescribed by your doctor.

You have had a problem with alcohol or drugs in the past year.

I have a history of seizures or significant tics, not including febrile seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an at-home, game-based digital therapy for ADHD

9 weeks

At-home therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ADHD Therapy
• Control Therapy

Trial Overview The trial is testing the safety and effectiveness of a new at-home digital therapy for adults with ADHD. It's game-based and compared against a control therapy. Participants will use this intervention in their own environment to see if it helps manage their symptoms better than existing methods.

How Is the Trial Designed?

Group I: ADHD Therapy Experimental Treatment 1 Intervention

Group II: Control Therapy Active Control 1 Intervention

Who Is Running the Clinical Trial?

Lumos Labs, Inc.

Lead Sponsor

Trials

15

Recruited

16,200+

Published Research Related to This Trial

ADHD medications, particularly stimulants, are effective treatments but can lead to various side effects, making it crucial to understand their prevalence and management strategies.

The review highlights the importance of recognizing and managing adverse events associated with ADHD medications to ensure safe and effective treatment for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the risks of ADHD treatments. Schneider, BN., Enenbach, M.[2021]

The automated trigger algorithm successfully identified potential adverse events in 8% of parent-reported ADHD assessments, leading to timely clinician reviews and changes in care plans for 46% of actionable alerts.

Patients with triggered alerts showed significantly worsened ADHD severity scores prior to the alerts, indicating that the algorithm effectively highlighted those needing immediate attention and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Timely Interventions for Children with ADHD through Web-Based Monitoring Algorithms. Oppenheimer, J., Ojo, O., Antonetty, A., et al.[2020]

A systematic review of 35 studies on ADHD treatments showed that all recommended interventions led to significant improvements in core symptoms, with reductions in symptoms ranging from 20% to 86%.

The studies, primarily using DSM-criteria-based rating scales, demonstrated a consistent pattern of improvement across various treatment types, suggesting that measuring symptom reduction within one year could serve as an effective outcome measure for ADHD care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations and evidence for an ADHD outcome measure. Woods, D., Wolraich, M., Pierce, K., et al.[2019]

The safety profile of ADHD medications is not fully understood, with concerns about both older and newer medications potentially causing serious adverse effects, including sudden cardiac death and suicidality.

A review by the European Network for Hyperkinetic Disorders highlighted that while some adverse effects may be minimal or similar to risks in untreated individuals, further research is needed to clarify the safety risks associated with ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

European guidelines on managing adverse effects of medication for ADHD. Graham, J., Banaschewski, T., Buitelaar, J., et al.[2022]

In a study of 1429 ADHD patients across 16 centers, those receiving combined treatment (medication and psychological therapy) showed a significantly higher improvement rate (65.5%) compared to those on methylphenidate alone (54.4%), psychological treatment alone (53.4%), or no therapy (40.5%).

There was considerable variation in treatment outcomes between centers, with the expected probability of improvement ranging from 47.7% to 61.2%, suggesting that center-specific approaches and attitudes significantly influence patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences between centers in functional outcome of patients with ADHD after 1 year from the time of diagnosis. Cartabia, M., Finazzi, S., Bonati, M.[2023]

A review of 43 studies involving around 7000 children found that common adverse drug reactions (ADRs) from ADHD medications included decreased appetite, gastrointestinal pain, and headaches, primarily reported by children or their parents.

Most studies reported low rates of serious ADRs, but many children dropped out due to serious reactions, suggesting that the actual incidence of serious ADRs may be higher, highlighting the need for long-term safety studies on ADHD medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The occurrence of adverse drug reactions reported for attention deficit hyperactivity disorder (ADHD) medications in the pediatric population: a qualitative review of empirical studies. Aagaard, L., Hansen, EH.[2021]

Citations

1. nature.com nature.com/articles/s41598-024-73934-3

Clinical study on the intervention effect of digital therapy ... To evaluate the efficacy and safety of digital therapy for children aged 6 to 12 years with attention deficit hyperactivity disorder (ADHD).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032724013910

The effect of digital interventions on attention deficit ... The digital interventions proved beneficial for individuals with ADHD by alleviating symptoms of ADHD, inattention, and hyperactivity/impulsivity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162428/

Improving the efficacy and effectiveness of evidence-based ... Overall, commercialized BPT and homegrown BPT have been found to be effective in improving the functioning of children with ADHD and their ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2909688/

Current Status of Cognitive Behavioral Therapy for Adult ... At post-treatment, 31% of group members showed at least 20% improvement on a self-report adult ADHD rating scale; however, there were no changes in observed ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-05673-8

One-year follow-up of the effectiveness and mediators of ... The long-term effectiveness of CBT in medicated ADHD adults with residual symptoms was further confirmed. The CBT conceptual model was verified ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19621975/

Efficacy and safety limitations of attention-deficit ... Findings of the Multimodal Treatment of Children With ADHD study suggest that the combination of behavioural and medical therapy may benefit most patients.

7. cdc.gov cdc.gov/adhd/data/index.html

Data and Statistics on ADHD About 30% of children with ADHD did not receive medication treatment or behavior treatment, compared with 23% of children 2–17 years of age with ...

8. publications.aap.org publications.aap.org/pediatrics/article/144/4/e20192528/81590/Clinical-Practice-Guideline-for-the-Diagnosis

Clinical Practice Guideline for the Diagnosis, Evaluation ... Mortality associated with attention-deficit hyperactivity disorder (ADHD) drug treatment: a retrospective cohort study of children ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006322319312740

Review Risks and Benefits of Attention-Deficit/Hyperactivity ... These studies suggested short-term beneficial effects of ADHD medication on several behavioral or neuropsychiatric outcomes (i.e., injuries, motor vehicle ...