ADHDMyADHDNCT04726813
An Internet-delivered Intervention for Coping With ADHD in Adulthood
A study testing MyADHD and Psychoeducation in people with ADHD, run by University of Bergen at 1 site in Norway.
Trial summary
The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD
- What is being tested?
- MyADHD and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- 27 Apr 2021to 20 Dec 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
- Access to and ability to use a computer, smartphone and the Internet.
- Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
- Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
- Speaks, writes and reads Norwegian
Who cannot join
- Current self-reported diagnosis of severe psychiatric illness such as borderline or antisocial personality disorder, bipolar disorder, ongoing substance abuse, and/or suicidal ideation assessed with item 9 on the MADRS
- Participants who are taking prescribed ADHD medication have to be stable on the medication at least four weeks before the study and during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial
The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes.
Read the detailed description
ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is poor. Interventions delivered over the Internet might help to increase the availability of effective psychological interventions for this group. The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes. A minimum of 118 participants with a self-reported ADHD diagnosis will be included in the study. In phase 1 we will conduct a randomized controlled trial with two arms, 1) self-guided Internet-delivered intervention for coping with ADHD (N=59), 2) self-guided online psychoeducation (control group, N= 59), with a 3 month follow-up. After 3 months the second phase of the study starts. In this phase (II) the control group participants will receive an adaptive version of the Internet-delivered intervention. This includes adaptation of the order of the modules to the individual participant needs, with the use of rule-based and machine-learning based adaptation. Clinical outcomes in both phases are inattention, hyperactivity, quality of life and stress. Uptake, usage, adherence and satisfaction will be explored. Repeated measurers are at baseline, weekly during the intervention period, post-intervention and 3 months follow-up.
- Conditions
- ADHD
- Being tested
- MyADHD, Psychoeducation
- Keywords
- ADHD, RCT, Internet-delivered intervention, Self-help, Coping
- 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.
MyADHDBehavioural
The main goals of the intervention are to help participants with better functioning in daily life; offer strategies that will lead to stress reduction and reduce inattention and improve quality of life.The intervention includes: a short introductory chapter (open to everyone), followed by a start module (goal setting), followed by 6 different themed optional modules. Module content is based on GMT, DBT and CBT techniques and is tailored towards key concerns and difficulties experienced adults with ADHD as informed by previous research (focus-groups, lived experience groups) and experiences from group GMT and DBT.
PsychoeducationBehavioural
Participants in the control condition will be assigned to psychoeducation modules (see Table 2) and will receive restricted access to the platform. They can contact or be contacted if their symptoms levels increases.
| Study group | Role | What they receive |
|---|---|---|
| a self-guided Internet delivered intervention | Experimental | MinADHD: 7 self-help modules. Receives: Behavioral: MyADHD |
| Psycho-education | Placebo comparator | One self-guided psychoeducation module Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Adult ADHD Self-Rating Scale (ASRS)
The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).
Measured: Change in ADHD symptoms at 8 weeks
Adult ADHD Quality of Life Measure (AAQol)
The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.
Measured: Change in quality of life at 8 weeks
Secondary outcomes (2)
The perceived stress scale (PSS)
The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress.
Measured: Change in stress symptoms at 8 weeks
The Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9: Kroenke et al., 2001) is a self-report tool used to assess the presence and severity of depressive symptoms
Measured: Change in depression symptoms at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start27 Apr 2021
- Primary completion20 Oct 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Robin Maria Francisca Kenter, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726813
- Sponsor's protocol ID
- 203804
- Acronym
- MyADHD
- Status last verified
- Jun 2022
- First submitted
- 8 Jan 2021
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kenter RMF, Gjestad R, Lundervold AJ, Nordgreen T. A self-guided internet-delivered intervention for adults with ADHD: Results from a randomized controlled trial. Internet Interv. 2023 Mar 20;32:100614. doi: 10.1016/j.invent.2023.100614. eCollection 2023 Apr.
PubMed 36969389Kenter RMF, Lundervold AJ, Nordgreen T. A self-guided Internet-delivered intervention for adults with ADHD: a protocol for a randomized controlled trial. Internet Interv. 2021 Nov 20;26:100485. doi: 10.1016/j.invent.2021.100485. eCollection 2021 Dec.
PubMed 34877262
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04726813
- Acronym / sponsor ID
- MyADHD / 203804
- Conditions
- ADHD
- Keywords
- ADHD, RCT, Internet-delivered intervention, Self-help, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Collaborators
- The Research Council of Norway
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 27 Jan 2021 (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 aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes.
Detailed description
ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is poor. Interventions delivered over the Internet might help to increase the availability of effective psychological interventions for this group. The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes. A minimum of 118 participants with a self-reported ADHD diagnosis will be included in the study. In phase 1 we will conduct a randomized controlled trial with two arms, 1) self-guided Internet-delivered intervention for coping with ADHD (N=59), 2) self-guided online psychoeducation (control group, N= 59), with a 3 month follow-up. After 3 months the second phase of the study starts. In this phase (II) the control group participants will receive an adaptive version of the Internet-delivered intervention. This includes adaptation of the order of the modules to the individual participant needs, with the use of rule-based and machine-learning based adaptation. Clinical outcomes in both phases are inattention, hyperactivity, quality of life and stress. Uptake, usage, adherence and satisfaction will be explored. Repeated measurers are at baseline, weekly during the intervention period, post-intervention and 3 months follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a self-guided Internet delivered intervention | Experimental | Behavioral: MyADHDMinADHD: 7 self-help modules. |
| Psycho-education | Placebo comparator | Behavioral: PsychoeducationOne self-guided psychoeducation module |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
- Access to and ability to use a computer, smartphone and the Internet.
- Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
- Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
- Speaks, writes and reads Norwegian
Key exclusion criteria (2 listed)
- Current self-reported diagnosis of severe psychiatric illness such as borderline or antisocial personality disorder, bipolar disorder, ongoing substance abuse, and/or suicidal ideation assessed with item 9 on the MADRS
- Participants who are taking prescribed ADHD medication have to be stable on the medication at least four weeks before the study and during the study.
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 |
|---|---|---|
| MyADHDThe main goals of the intervention are to help participants with better functioning in daily life; offer strategies that will lead to stress reduction and reduce inattention and improve quality of life.The intervention includes: a short introductory chapter (open to everyone), followed by a start module (goal setting), followed by 6 different themed optional modules. Module content is based on GMT, DBT and CBT techniques and is tailored towards key concerns and difficulties experienced adults with ADHD as informed by previous research (focus-groups, lived experience groups) and experiences from group GMT and DBT. | Behavioural | a self-guided Internet delivered intervention |
| PsychoeducationParticipants in the control condition will be assigned to psychoeducation modules (see Table 2) and will receive restricted access to the platform. They can contact or be contacted if their symptoms levels increases. | Behavioural | Psycho-education |
Primary outcome
The Adult ADHD Self-Rating Scale (ASRS)
Time frame: Change in ADHD symptoms at 8 weeks
The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).
Adult ADHD Quality of Life Measure (AAQol)
Time frame: Change in quality of life at 8 weeks
The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.
2 secondary outcomes
The perceived stress scale (PSS)
Time frame: Change in stress symptoms at 8 weeks
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Change in depression symptoms at 8 weeks
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 15 Jun 2022.
- Derived from this study: PubMed 36969389Kenter RMF, Gjestad R, Lundervold AJ, Nordgreen T. A self-guided internet-delivered intervention for adults with ADHD: Results from a randomized controlled trial. Internet Interv. 2023 Mar 20;32:100614. doi: 10.1016/j.invent.2023.100614. eCollection 2023 Apr.
- Derived from this study: PubMed 34877262Kenter RMF, Lundervold AJ, Nordgreen T. A self-guided Internet-delivered intervention for adults with ADHD: a protocol for a randomized controlled trial. Internet Interv. 2021 Nov 20;26:100485. doi: 10.1016/j.invent.2021.100485. eCollection 2021 Dec.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyADHD and Psychoeducation in people with ADHD, run by University of Bergen 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 5 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 15 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
The Adult ADHD Self-Rating Scale (ASRS) (time frame: Change in ADHD symptoms at 8 weeks). 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?
On the ClinicalTrials.gov record for NCT04726813, which also lists 2 linked publications.
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 15 Jun 2022.