ADHDMinADHDNCT06299189
A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care
A study testing MinADHD in people with ADHD and ADHD - Combined Type, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on: i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD, ADHD - Combined Type, ADHD Predominantly Inattentive Type
- What is being tested?
- MinADHD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18
- A self-reported diagnosis of ADHD
- Access to and ability to use a computer, smartphone and the Internet.
- Speaks, writes and reads Norwegian
Who cannot join
- In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis.
- Ongoing psychological treatment for ADHD or other psychiatric illnesses.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site, 1 recruiting
- Recruiting
Bjørgvin DPS
Bergen
Gunn Elise Sæthre, 00000000
About this study
Official title: A Therapist Guided Internet-delivered Treatment for Adults With ADHD - an Open Effectiveness Trial in Routine Care
The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:
- Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.
Read the detailed description
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across time and situations. ADHD in adulthood, with estimated prevalence of 2-3%, is associated with challenges that may have severe consequences on daily life functioning. Treatments delivered over the Internet on smartphones or personal computers may help to increase the availability of effective psychological interventions for a larger group of adults with ADHD. The overall aim of this study is to investigate 1) predictors of effect; 2) implementation outcomes; and the 3) cost-benefit of a therapist guided Internet-delivered treatment for adults with an ADHD diagnosis. The study is an open longitudinal cohort trial in routine care. A total of 200 participants with an ADHD diagnosis will be included in the trial, and 15 participants will be interviewed about their experiences with guided Internet-delivered treatment. The outcomes are change in primary and secondary symptoms and quality of life, cost-benefit and implementation outcomes of guided internet-delivered treatment for adults with ADHD. The investigators will use quantitative statistical procedures and qualitative methods to analyze the data. The results from the study will contribute to the growing research on Internet-delivered treatments. The expected results may have a major impact on treatment provision and the further development of treatment options for adults with ADHD. Moreover, investigating ways to increase adoption, adherence and fidelity in Internet-delivered treatment could be of great value when implementing such treatment into routine care.
- Conditions
- ADHD, ADHD - Combined Type, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- Being tested
- MinADHD
- 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.
MinADHDBehavioural
Guided self-help, 7 modules Interventions
| Study group | Role | What they receive |
|---|---|---|
| A self-guided internet delivered intervention | Experimental | MinADHD: 7 self-help modules Interventions: Behavioural Receives: Behavioral: MinADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Adult ADHD Self-Rating Scale
Measure of ADHD symptom severity
Measured: From enrollment to the end of 6-months follow-up
Adult ADHD Quality of Life Measure
Measure of impact of ADHD on quality of life
Measured: From enrollment til the end of 6-month follow-up.
Secondary outcomes (4)
The Patient Health Questionnaire
Measure of depression
Measured: From enrollment til the end of 6-month follow-up.
Generalized Anxiety Disorder-7
Measure of anxiety
Measured: From enrollment til the end of 6-month follow-up.
Personality Disorder Severity ICD-11
Measure of personality functioning
Measured: From enrollment til the end of 6-month follow-up.
EuroQoL 5D-5L
Measure of health-related quality of life
Measured: From enrollment to end of 6-month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Jan 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299189
- Sponsor's protocol ID
- 309264
- Acronym
- MinADHD
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD collected for the current trial is considered sensitive patient information.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Therapist Guided Internet-delivered Treatment for Adults With ADHD - an Open Effectiveness Trial in Routine Care
- ClinicalTrials.gov ID
- NCT06299189
- Acronym / sponsor ID
- MinADHD / 309264
- Conditions
- ADHD, ADHD - Combined Type, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Mar 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.
The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:
- Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.
Detailed description
Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across time and situations. ADHD in adulthood, with estimated prevalence of 2-3%, is associated with challenges that may have severe consequences on daily life functioning. Treatments delivered over the Internet on smartphones or personal computers may help to increase the availability of effective psychological interventions for a larger group of adults with ADHD. The overall aim of this study is to investigate 1) predictors of effect; 2) implementation outcomes; and the 3) cost-benefit of a therapist guided Internet-delivered treatment for adults with an ADHD diagnosis. The study is an open longitudinal cohort trial in routine care. A total of 200 participants with an ADHD diagnosis will be included in the trial, and 15 participants will be interviewed about their experiences with guided Internet-delivered treatment. The outcomes are change in primary and secondary symptoms and quality of life, cost-benefit and implementation outcomes of guided internet-delivered treatment for adults with ADHD. The investigators will use quantitative statistical procedures and qualitative methods to analyze the data. The results from the study will contribute to the growing research on Internet-delivered treatments. The expected results may have a major impact on treatment provision and the further development of treatment options for adults with ADHD. Moreover, investigating ways to increase adoption, adherence and fidelity in Internet-delivered treatment could be of great value when implementing such treatment into routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A self-guided internet delivered intervention | Experimental | Behavioral: MinADHDMinADHD: 7 self-help modules Interventions: Behavioural |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18
- A self-reported diagnosis of ADHD
- Access to and ability to use a computer, smartphone and the Internet.
- Speaks, writes and reads Norwegian
Key exclusion criteria (2 listed)
- In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis.
- Ongoing psychological treatment for ADHD or other psychiatric illnesses.
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 |
|---|---|---|
| MinADHDGuided self-help, 7 modules Interventions | Behavioural | A self-guided internet delivered intervention |
Primary outcome
The Adult ADHD Self-Rating Scale
Time frame: From enrollment to the end of 6-months follow-up
Measure of ADHD symptom severity
Adult ADHD Quality of Life Measure
Time frame: From enrollment til the end of 6-month follow-up.
Measure of impact of ADHD on quality of life
4 secondary outcomes
The Patient Health Questionnaire
Time frame: From enrollment til the end of 6-month follow-up.
Generalized Anxiety Disorder-7
Time frame: From enrollment til the end of 6-month follow-up.
Personality Disorder Severity ICD-11
Time frame: From enrollment til the end of 6-month follow-up.
EuroQoL 5D-5L
Time frame: From enrollment to end of 6-month follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No. The IPD collected for the current trial is considered sensitive patient information.
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MinADHD in people with ADHD and ADHD - Combined Type, run by Haukeland University Hospital at 1 site in Norway.
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 4 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: looking for participants now, as of the sponsor's last update on 26 Aug 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aleksander Heltne (00000000, aleksander.gulla.heltne@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Adult ADHD Self-Rating Scale (time frame: From enrollment to the end of 6-months follow-up). The study lists 2 primary outcomes in all. 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 26 Aug 2025.