Assessing Mobile Apps for Adult ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

A Randomized, Controlled, Parallel-Group, Intervention Study to Assess At-Home, Digital Therapy for Treating Adult Participants Ages 18-50 Years Old With Attention Deficit Hyperactivity Disorder (ADHD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256003
• Other study ID #: SAC-II
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: October 2024

Study information

• Verified date: March 2024
• Source: Think Now Incorporated
• Contact: Kristen Emanuel, MS
• Phone: 310-205-1200
• Email: KEnriquez[@]mednet.UCLA.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to evaluate the effects of mobile app digital therapies on cognitive function and symptoms in adults diagnosed with ADHD.

Description:

The study is a randomized, parallel group, controlled trial of two mobile app digital therapies. The study will consist of initial screening tests and diagnostics to determine eligibility, followed by outcome measure testing and treatment. On Day 0, the Baseline visit will occur wherein the pre-treatment (baseline) assessments will be conducted on-site. The Treatment period (Day 1 to Day 49) will involve using the digital therapy at home. Midpoint (Day 25) assessments will be conducted on-site to assess key outcomes. Final Post-Treatment (Day 50) assessments will be conducted on-site to assess key outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: October 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• The participant is aged 18-50 years at time of consent

• Fluent in English.

• Available for 2 contiguous months to participate in study, including 3 in-person visits to the university.

• Able to sit in a regular chair for 30 minutes in a small room for testing.

• Able to use a keyboard with both hands.

• Normal or corrected to normal vision and hearing.

• 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:

• 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.

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

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

• Current Persistent Depressive Disorder (Dysthymia) or Anxiety Disorder if not on allowed medication that has been at a stable dose for at least 8 weeks (if on allowed medication with stable dose for 8 weeks, then allow).

• 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).

• 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.

• History of chronic fatigue syndrome, Long-COVID.

• Other medical or psychiatric conditions that are sufficient to likely compromise current attentional function and assessment in the opinion of the investigator.

• Current ongoing treatment, deemed by the participant and their PCP as indicated for continued use during the study, with psychotropics suspected to alter attentional functioning such as antipsychotic medications, sedative hypnotics, mood stabilizers, benzodiazepines, atypical antidepressants, or anticonvulsants (listed in the Excluded Medications List, or in the opinion of the investigator are likely to interfere with study cognitive assessments).

• Participant is currently considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or has a prior history of, or is currently demonstrating active suicidal ideation or self-injurious behavior as measured by Columbia Suicide Severity Rating Scale at screening.

• Current treatment with guanfacine (due to the unacceptable risks of rapid withdrawal) and other medications for focus and attention problems such as Strattera, Modafinil, Armodafinil, and Clonidine that require long wash out periods (see Excluded ADHD Medications List).

• Participant plans to initiate during the primary study new concomitant prescription medications that are on the Excluded Medications List.

• Participant plans to initiate during the primary study behavioral therapy or training to improve cognition by means of game or app-based cognitive trainings or neurofeedback.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Device:
• UC-A
Mobile app digital therapy
• UC-N
Mobile app digital therapy

Locations

Country	Name	City	State
United States	University of California Berkeley	Berkeley	California
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Think Now Incorporated	University of California, Berkeley, University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adult ADHD Quality of Life Scale (AAQoL) - Productivity. (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)	AAQoL - Productivity is an 11-item subscale the participant respondent rates the frequency of occurrence of behaviors and feelings relevant to quality of life. Each item is scored on a 5-point scale ranging from 1 (never) to 5 (very often). For scoring purposes the scores are reversed so that larger scores reflect better quality of life. The subscale scores range from 0-100. The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the AAQoL Productivity score is Productivity at Day 25 minus Productivity at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is Productivity at Day 50 minus Productivity at Day 0.; A positive change indicates improvement on the subscale from Day 0 to Day 25 and Day 0 to Day 50.	Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
Primary	Conners Continuous Performance Task (CPT3) - HRT Std (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)	Conners CPT-HRT Std (Hit Reaction Time Standard Deviation) is the standard deviation of the reaction time of hits to target stimuli over the entire test. The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the Conners HRT Std is HRT Std at Day 25 minus HRT Std at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is HRT Std at Day 50 minus HRT Std at Day 0. Higher scores represent more variability in responding, reflecting poorer sustained attention control. A negative change in score represents improvement in sustained attention control.	Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
Secondary	Nelson Denny Reading Comprehension Test (NDRT) - Reading Comprehension Scaled Score (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)	NDRT - Reading Comprehension Scaled Score (Reading Comp) is the total comprehension score for the full 20-minute, 36-item reading test based on the number of correct answers. The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the NDRT Reading Comp is Reading Comp at Day 25 minus Reading Comp at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is Reading Comp at Day 50 minus Reading Comp at Day 0. Higher scores represent more correct answer reflecting better comprehension. A positive change in score represents improvement in reading comprehension.	Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)
Secondary	Barkley Adult ADHD Rating Scale (BAARS-IV) - Inattentive Subscale (Inatt). (Change from Baseline to Midpoint Mid-treatment, and Baseline to Endpoint Post-treatment)	The BAARS-IV is an 18-item, self-report questionnaire for which the participant respondent rates the frequency of occurrence of ADHD symptoms and behaviors as defined by criteria outlined for ADHD in the DSM-5. Each item is scored on a 4-point scale ranging from 1 (never or rarely) to 4 (very often).; The 18 items are grouped into 2 subscales. Each subscale produces a sub-scale score ranging from 0-36. A lower subscale score indicates less severe ADHD symptoms and behaviors.; The calculation of the difference between Baseline and Midpoint (Mid-treatment) in the BAARS-IV Inatt score is Inatt at Day 25 minus Inatt at Day 0; and the difference between Baseline and Endpoint (Post-treatment) is Inatt at Day 50 minus Inatt at Day 0 A negative change indicates improvement on the subscale from Day 0 to Day 25 and Day 0 to Day 50.	Baseline (Day 0) and Midpoint (Day 25), and Baseline (Day 0) and Endpoint (Day 50)