Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder

Adult Attention Deficit Hyperactivity Disorder Clinical Trial

— READ-ADHD  

Official title:

Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221930
• Other study ID #: attexis RCT 2024
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Gaia AG
• Contact: Gitta A. Jacob, PhD
• Phone: +49.40.349930-374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this randomized controlled clinical trial, 326 patients with ADHD will be investigated regarding the effectiveness of a digital therapeutic for improved ADHD symptomatology, the unguided online intervention attexis. Inclusion criteria are: male, female or non-binary, age 18-65, diagnosis of ADHD, elevated levels of ADHD symptoms (score of ≥17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the ASRS v1.1), stable treatment for at least 30 days at time of inclusion, sufficient German skills, and consent to participation. Exclusion criteria are: Diagnosis of any other severe psychiatric disorder and plans to change treatment in the upcoming three months. Patients will be randomized and allocated to either an intervention group, receiving access to attexis in addition to TAU, or a control group, receiving access to TAU only. Primary endpoint will be self-rated ADHD symptomatology, assessed via the ASRS v1.1, with three months post-allocation being the primary time point for assessment of effectiveness. Six months post allocation will be used as a timepoint for follow-up assessment of endpoints. Secondary endpoints will be depressive symptoms, self-esteem, work and social functioning, and health-related quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• women, men, non-binary
• age 18-65 years
• diagnosis of ADHD (assessed via DIVA)
• ADHD severity score (cut-off): score of =17 either on the inattention subscale or on the impulsivity/hyperactivity subscale of the ASRS v1.1
• stable treatment (psychotherapy, medication, no treatment, …) for at least 30 days at the time of inclusion
• consent to participation
• sufficient knowledge of the German language

Exclusion Criteria:

• diagnosis of another severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, Borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality)
• plans to change treatment (psychotherapy, medication, …) in the upcoming three months after inclusion

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• attexis
Participants will receive access to the digital health intervention attexis in addition to TAU.

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	University Hospital, Saarland, Zentrum für Integrative Psychiatrie Kiel

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADHD Symptom Severity	ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).	3 months
Secondary	Depressive Symptomatology	PHQ-9. Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).	3 months, 6 months
Secondary	Self Esteem	Rosenberg Self Esteem Scale (RSES). Total score ranging from 0-30; higher scores mean higher self-esteem (better outcome).	3 months, 6 months
Secondary	Functioning	Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).	3 months, 6 months
Secondary	Health-Related Quality of Life	AQoL-8D. Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).	3 months, 6 months
Secondary	ADHD Symptom Severity	ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).	6 months