Mobile Apps for ADHD

No longer recruiting at 1 trial location

Overseen By Stephen P Hinshaw, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Think Now Incorporated

Must not be taking: Antipsychotics, Benzodiazepines, Anticonvulsants, others

Disqualifiers: Bipolar, Psychotic, PTSD, others

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

Compensation: Varies

Number of Visits: 3

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the impact of two mobile apps, UC-A and UC-N, designed to improve attention and problem-solving skills in adults diagnosed with ADHD (Attention Deficit Hyperactivity Disorder). Participants will use one of these digital therapies daily for seven weeks to determine if the apps can enhance cognitive function and better manage ADHD symptoms. The trial is ideal for English-speaking adults diagnosed with ADHD who can participate for two months, including attending three in-person visits at the university. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new ADHD management methods.

Will I have to stop taking my current medications?

The trial requires stopping certain medications that affect attention, such as guanfacine, Strattera, Modafinil, Armodafinil, and Clonidine, due to the need for a long washout period (time without taking these medications). If you are on other medications that affect attention, you may need to stop them if they are on the Excluded Medications List.

What prior data suggests that these mobile app digital therapies are safe for adults with ADHD?

Research has shown that digital mobile apps, like those in this trial, are usually easy for people to use. In one study, a different app designed to help adults with ADHD improve focus and control did not cause any major safety problems over 7 weeks. This suggests that similar digital tools, like UC-A and UC-N, are likely safe for users.

Additionally, digital apps for ADHD have been tested in many situations and are often found suitable for both children and adults. These apps aim to improve symptoms through brain exercises or problem-solving activities. While specific information on side effects is limited, using apps is generally safer than taking medication because they don't involve any physical procedures.

These findings provide some comfort about the safety of using mobile apps to manage ADHD symptoms. However, if participants notice anything unexpected during a trial, they should inform the researchers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for ADHD because they utilize mobile app interventions to improve cognitive control skills. Unlike traditional medications that often focus on neurotransmitter balance, UC-A and UC-N offer a digital approach to enhance task performance and problem-solving skills, respectively. This method is unique as it provides a non-pharmacological option, which can be more appealing for those seeking alternatives to medication. Additionally, these apps are convenient and easy to integrate into daily life, being used once a day, five days a week, for seven weeks. This innovative approach offers a fresh perspective on managing ADHD symptoms with the potential for fewer side effects.

What evidence suggests that this trial's mobile app treatments could be effective for ADHD?

Research shows that digital health tools might help manage ADHD symptoms. In this trial, participants will use one of two digital mobile app interventions. Studies have found that apps like UC-A, which aid in focusing on tasks, can improve attention and self-control. Meanwhile, UC-N enhances problem-solving, which can also boost these skills. Early results suggest that these digital apps can effectively improve focus and reduce ADHD symptoms. These tools are promising because they make treatment more accessible and engaging for users. ^{6 7 8 9 10}

Who Is on the Research Team?

Robert Bilder, Ph.D

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have a smart Phone

Estimated Intelligence Quotient (IQ) > 80 as assessed by the Wechsler Abbreviated Scale Intelligence (WASI-II) Matrix Reasoning and Vocabulary subtests

Meet established Diagnostic and Statistical Manual of Mental Health-Fifth Edition (DSM-5-TR) presentation for ADHD predominantly inattentive or combined subtype with clinically significant levels of impairment, diagnosed by semi-structured clinical interview and the Adult ADHD Clinical Diagnostic Scale (ACDS)

Exclusion Criteria

Lifetime history of DSM5 bipolar disorder, psychotic disorder, panic disorder, agoraphobia, obsessive compulsive disorder as assessed with the MINI International Neuropsychiatric Interview (MINI)

History of diagnosis of childhood neurodevelopmental disorder including autism spectrum disorder and dyslexia, other than ADHD or those specifically allowed in the Allowed Disorders section

Substance or Alcohol Use Disorder rated as moderate or severe, with symptoms ≥ 4, as assessed by the MINI, or self-report of a Substance/Alcohol Use Disorder (allow endorsement of substance or alcohol use that does not meet moderate-severe use disorder criterion, if clean at visit)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline

Pre-treatment assessments conducted on-site

1 day

1 visit (in-person)

Treatment

Participants use the digital therapy at home

7 weeks

1 visit (in-person) at midpoint, 1 visit (in-person) at endpoint

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• UC-A
• UC-N

Trial Overview 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.

How Is the Trial Designed?

Group I: UC-A Active Control 1 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-N Active Control 1 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.

Who Is Running the Clinical Trial?

Think Now Incorporated

Lead Sponsor

Trials

4

Recruited

590+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

University of California, Berkeley

Collaborator

Trials

193

Recruited

716,000+

Published Research Related to This Trial

Several new therapies for gout have emerged, focusing on lowering serum urate levels and treating gout flares, with verinurad being highlighted as the most promising urate-lowering therapy.

Arhalofenate shows potential for both urate lowering and anti-inflammatory effects, but further data is needed to confirm its efficacy and safety, along with other therapies like bucillamine and those in early development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert opinion on emerging urate-lowering therapies. Stamp, LK., Merriman, TR., Singh, JA.[2018]

Citations

1. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06456372

Digital Health Intervention for Children With ADHD This Attention-Deficit/Hyperactivity Disorder study at UC Irvine is now recruiting people ages 8-12.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06456372

Digital Health Intervention for Children With ADHD Our digital health intervention (DHI) uses Patient-Centered Digital Healthcare Technologies (PC-DHT) to promote co-regulation (child/parent), capture patient ...

3. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/digital-health-intervention-children-adhd-improving-mental-health-intervention

Digital Health Intervention for Children with ADHD: Improving ... This research will adapt an evidence-based digital health intervention for attention deficit hyperactivity disorder in children to improve communication and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11534993/

Digital health intervention for children with ADHD to ... We developed the digital health intervention (DHI)—CoolTaCo [Cool Technology Assisting Co-regulation] to address these critical barriers ...

5. 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).

6. health.ucdavis.edu health.ucdavis.edu/news/headlines/smartphone-app-to-track-adhd-symptoms-behavior-in-people-with-neurodevelopmental-conditions/2021/10

Smartphone app to track ADHD symptoms, behavior in ... The goal is to track symptoms related to executive function, often associated with ADHD, using the new smartphone app, called iBehavior.

7. medschool.ucla.edu medschool.ucla.edu/sites/default/files/media/documents/UCLA_flyer_final.pdf

UCLA Study on mobile app to increase cognitive control in ... The purpose of this 7-week study is to examine the effects of cognitive training with a mobile app in adults with ADHD. You are eligible to participate if ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9857426/

The Development and Usability of a Mobile App for Parents ... A mobile app can be used as an add-on in psychotherapy with parents of children with ADHD. Digital health interventions could help surpass gaps in treatment ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S138650561830323X

Attention-deficit/ hyperactivity disorder mobile apps We found 109 ADHD apps in the virtual stores available to both young and adult populations, developed for children, adolescents, parents, teachers, and ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11164876/

A mobile device-based game prototype for ADHD This research aimed to devise and assess a mobile game therapy software for children with Attention-Deficit/Hyperactivity Disorder (ADHD), ...