Virtual Reality Treatment for Emerging Adults With ADHD

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Development of a Novel Virtual Reality Treatment for Emerging Adults With ADHD

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06454604
• Other study ID #: Pro2023001005
• Secondary ID: R61MH131632-01
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Rutgers, The State University of New Jersey
• Contact: Joshua M Langberg, PhD
• Phone: (848) 445-2000
• Email: jl3079[@]gsapp.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this pilot randomized clinical trial is to test the impact of a virtual reality program for improving the ability of emerging adults (age 18-25) with attention deficit hyperactivity disorder (ADHD) to stay focused while completing homework and studying. This study compares the impact of using a virtual reality headset to using a virtual reality headset while also receiving feedback about levels of focus to a control group. The main question is whether participants demonstrate significantly improved concentration while completing homework and studying in virtual reality and whether they enjoy and prefer working in a virtual reality environment. Concentration is measured both through participant report and also using keyboard and mouse click data to assess work productivity objectively.

Description:

This study involves a pilot randomized control trial (RCT) to assess the feasibility/usability and preliminary effects of a virtual reality (VR) environment alone (n=15) compared to VR environment + feedback about focus (n=15) and to a VR passthrough control (n=15). Proposed mechanisms of action will be measured every session, including data on keyboard and mouse clicks plus self-ratings of concentration, homework effort, and homework motivation. After completing the initial diagnostic evaluation and confirming eligibility, 45 emerging adults with ADHD (ages 18-25) will be randomized to 1 of 3 groups and then provided with a VR headset and computer to use in their dorm/home. Randomization will be performed (1:1:1) to the three conditions. Randomization will be blocked on ADHD medication status to ensure an equal number of participants taking and not taking ADHD medication in each group. Phase 3 includes a 2-session baseline where all participants complete homework and study without using the VR headset.

Group 1, VR passthrough: After completing the two session baseline, participants will use the VR headset in their room/home or the library 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. The participant will wear the headset, but it will not be used as usual. The headset will be in "VR passthrough" mode, meaning the participant will see through to the normal environment and laptop (i.e., they can see the real world around them, just wearing a headset).

Group 2, VR environment only: After completing the two session baseline, participants will use the VR headset in their room/home or the library 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. For the following sessions, the participant will wear the VR headset and engage in homework in the VR environment.

Group 2, VR environment + feedback: After completing the two session baseline, participants will use the VR headset in their room/home or the 10 times over two weeks (max twice a day with a minimum 2-hour break) for 1-hour sessions each time. For the following sessions, the participant will wear the VR headset and engage in homework in the VR environment while receiving real time visual feedback on performance and focus.

Participants concentration, effort/efficiency, and motivation is assessed each baseline and VR session, and participants answer questions about VR feasibility, useability, and acceptability.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: May 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• To be included, participants must meet DSM-5 criteria for ADHD and be between the ages of 18 and 25. Given high rates of comorbidities in college students with ADHD, participants who meet criteria for ODD, anxiety or depressive disorders on the diagnostic interview are not excluded. In addition, participants must have an item mean score of >2.0 (often or very often) on the homework task specific version of the Adult Concentration Index (ACI), ensuring the presence of a problem in the mechanism being targeted in this study. The participant has to endorse a total of at least 5 symptoms in the ADHD inattention domain as currently present and impairing and at least 6 symptoms in the ADHD inattention domain as present and impairing during childhood. To rule out exclusionary conditions and/or to assess for the presence of comorbid conditions, psychological functioning will be assessed using the DSM-5 version of the Structured Clinical Interview for DSM Disorders (SCID-5-RV)

Exclusion Criteria:

• Whether primary or not, the comorbid presence of several other conditions will be exclusionary. This includes autism spectrum disorders, bipolar disorder, obsessive-compulsive disorder, active substance abuse, and other psychiatric conditions whose treatment precludes participation in the study. Students who do not meet criteria for ADHD or who are not in the specified age range are also not eligible to participate. Students with a history of seizures are not eligible to participate given the use of VR.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Behavioral:
• Meta Quest 3 VR Headset with noise cancelling headphones
Wearing the headset and headphones removes all outside audio and visual distractions. One of the groups receives frequent and consistent feedback about work productivity similar to behavioral interventions for ADHD.

Locations

Country	Name	City	State
United States	Louisiana State University	Baton Rouge	Louisiana
United States	Rutgers University - New Brunswick	Piscataway	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey	Louisiana State University Health Sciences Center in New Orleans, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration	Participants rate their concentration and focus levels	Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over 2 weeks-1 month)
Primary	Productivity Rate	% of time on-task during each study session utilizing the Objective On-Task Assessment algorithmic mouse and keyboard click data	Measured throughout the 40-minute duration of each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Primary	System usability and satisfaction	Participants rate useability of the VR headset and satisfaction with use for studying.	Measured immediately after the 6th and 11th VR intervention sessions and in the post-intervention surveys (taking place over a total of 1-1.5 months)
Secondary	Motivation	Participants rate how motivated they were to complete work and study	Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)
Secondary	Effort	Participants rate how much effort they put into completing their work and studying	Measured at baseline assessment and immediately after each of the 12 VR intervention sessions (taking place over an estimated 2 weeks-1 month)