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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

337 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-11

Study Completion Date

2024-12-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Adult Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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attexis + TAU

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.

Group Type EXPERIMENTAL

attexis

Intervention Type BEHAVIORAL

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

TAU

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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attexis

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No