Adult Attention Deficit Hyperactivity DisorderREAD-ADHDNCT06221930
Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder
A study testing attexis in people with Adult Attention Deficit Hyperactivity Disorder, run by Gaia AG at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Attention Deficit Hyperactivity Disorder
- What is being tested?
- attexis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteGermany
- Study dates
- 11 Mar 2024to 25 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Trial
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.
- Being tested
- attexis
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
attexisBehavioural
Participants will receive access to the digital health intervention attexis in addition to TAU.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: attexis |
| TAU | No intervention | Participants allocated to the control group will receive access to treatment as usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Symptom Severity
ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).
Measured: 3 months
Secondary outcomes (5)
Depressive Symptomatology
PHQ-9. Total score ranging from 0-27; higher scores mean more depressive symptomatology (worse outcome).
Measured: 3 months, 6 months
Self Esteem
Rosenberg Self Esteem Scale (RSES). Total score ranging from 0-30; higher scores mean higher self-esteem (better outcome).
Measured: 3 months, 6 months
Functioning
Work and Social Adjustment Scale (WSAS). Total score ranging from 0-40; higher scores mean higher impairment (worse outcome).
Measured: 3 months, 6 months
Health-Related Quality of Life
AQoL-8D. Total score ranging from 0-100; higher scores mean higher quality of life (better outcome).
Measured: 3 months, 6 months
ADHD Symptom Severity
ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start11 Mar 2024
- Primary completion25 Sep 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zentrum für Integrative Psychiatrie, University Hospital, Saarland
- Responsible party
- Sponsor
- Investigators
- Eva Fassbinder, MD, Principal investigator, Zentrum für Integrative Psychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221930
- Sponsor's protocol ID
- attexis RCT 2024
- Acronym
- READ-ADHD
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity Disorder - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06221930
- Acronym / sponsor ID
- READ-ADHD / attexis RCT 2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- Zentrum für Integrative Psychiatrie, University Hospital, Saarland
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| attexis + TAU | Experimental | Behavioral: attexisParticipants 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. |
| TAU | No intervention | –Participants allocated to the control group will receive access to treatment as usual (TAU). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| attexisParticipants will receive access to the digital health intervention attexis in addition to TAU. | Behavioural | attexis + TAU |
Primary outcome
ADHD Symptom Severity
Time frame: 3 months
ASRS v1.1. Total score ranging from 0-72; higher scores mean more ADHD symptoms (worse outcome).
5 secondary outcomes
Depressive Symptomatology
Time frame: 3 months, 6 months
Self Esteem
Time frame: 3 months, 6 months
Functioning
Time frame: 3 months, 6 months
Health-Related Quality of Life
Time frame: 3 months, 6 months
ADHD Symptom Severity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Fassbinder, MD principal investigator
Zentrum für Integrative Psychiatrie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing attexis in people with Adult Attention Deficit Hyperactivity Disorder, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Symptom Severity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.