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

Not Applicable

Completed

• Conditions: Adult Attention Deficit Hyperactivity Disorder
• Interventions: Behavioral: attexis

• Registration Number: NCT06221930
• Lead Sponsor: Gaia AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-15
• Study First Submitted QC: 2024-01-15
• Study First Posted: 2024-01-24
• Study Start: 2024-03-11
• Primary Completion: 2024-09-25
• Study Completion: 2024-12-25
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 337

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
attexis + TAU	attexis	Participants allocated to the intervention group will receive access to attexis in addition to treatment as usual (TAU). attexis is a digital health application designed for individuals with adult attention deficit hyperactivity disorder (ADHD), accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by attexis are attention, self-image, impulsivity and physical exercise, problem-solving strategies, and resources. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.

Primary Outcome Measures

Name	Time	Method
ADHD Symptom Severity	3 months	ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

GAIA AG; 🇩🇪 Hamburg, Germany