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

NCT06221930 | Completed

• 1 other identifier: attexis RCT 2024
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• ADHD Symptom Severity

  ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).

  3 months

Secondary Outcomes (5)

• Depressive Symptomatology

  3 months, 6 months

• Self Esteem

  3 months, 6 months

• Functioning

  3 months, 6 months

• Health-Related Quality of Life

  3 months, 6 months

• ADHD Symptom Severity

  6 months

Study Arms (2)

attexis + TAU

EXPERIMENTAL

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.

Behavioral: attexis

TAU

NO INTERVENTION

Participants allocated to the control group will receive access to treatment as usual (TAU).

Interventions

attexis BEHAVIORAL

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

attexis + TAU

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• consent to participation
• sufficient knowledge of the German language

You may not qualify if:

• diagnosis of another severe psychiatric disorder (severe affective disorder, autism spectrum disorder, psychotic disorder, Borderline personality disorder, antisocial personality disorder, substance use disorder, suicidality)

Sponsors & Collaborators

• Gaia AG: lead
• Zentrum für Integrative Psychiatrie Kiel: collaborator
• University Hospital, Saarland: collaborator

Study Sites (1)

GAIA AG

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Eva Fassbinder, MD

  Zentrum für Integrative Psychiatrie Kiel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: March 11, 2024
• Primary Completion: September 25, 2024
• Study Completion: December 25, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)