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ADHD - Combined TypeMINADHDNCT04511169

MyADHD-digital Training for Adults With ADHD

A study testing digital self-help in people with ADHD - Combined Type, run by Haukeland University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Background: Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across situations and time. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
ADHD - Combined Type
What is being tested?
digital self-help
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteNorway
Study dates
20 May 2020to 1 Mar 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 diagnosis of ADHD
  • Access to a computer, smartphone and the Internet.
  • Speaks, writes and read Norwegian

Who cannot join

  • Current self-reported diagnosis of severe psychiatric illness (ongoing substance abuse, suicidal ideation or psychosis).
  • Ongoing psychological treatment for ADHD or other psychiatric illnesses.

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Community Sample

    Bergen, 5000

Other trials in Norway

About this study

Official title: A Self-guided Internet-delivered Intervention for Adults With ADHD: Study Protocol for a Micro-randomized Trial Investigating the Use of Reminders

Background: Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across situations and time. ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges that may have severe consequences on their daily life functioning. Still, the availability of evidence-based psychological interventions is limited. Interventions delivered over the Internet is promising, because it may increase the availability of effective psychological interventions for a larger group of adults with ADHD. However, studies show that lack of sustained adherence is a challenge in self-guided internet interventions. Digital reminders may help increase adherence and engagement in these interventions.

Read the detailed description

Background: Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across situations and time. ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges that may have severe consequences on their daily life functioning. Still, the availability of evidence-based psychological interventions is limited. Interventions delivered over the Internet is promising, because it may increase the availability of effective psychological interventions for a larger group of adults with ADHD. However, studies show that lack of sustained adherence is a challenge in self-guided internet interventions. Digital reminders may help increase adherence and engagement in these interventions.

Objectives: The overall aim of this study is to investigate adherence and effects of a self-guided Internet-delivered intervention for adults with an ADHD diagnosis. More detailed, we will examine whether the use of reminders will increase adherence and engagement in the intervention, and consequently how this affect intervention effects.

Methods: The study uses a micro-randomized design. A total of 100 participants with an ADHD diagnosis will be included. Primary measure is adherence (completed modules) and participant feedback regarding self-reported engagement. Secondary clinical outcomes: inattention and hyperactivity/impulsivity measured by two subscales from the Adult ADHD Self-Rating Scale (ASRS); quality of life measured by Adult ADHD Quality of Life Measure (AAQol); stress measured by the Perceived Stress Scale (PSS); cognitive functioning measured with the Perceived Deficit Questionnaire (PDQ-5), and self-compassion measured by the Self compassion-Scale - short form (SCS-SF). We will use quantitative statistical procedures and qualitative methods to analyze the data.

Discussion: The results from the study will contribute to the growing research on Internet-delivered interventions. The expected results may have a major impact on further development of treatment options for adults with ADHD. Moreover, investigating ways to increase adherence in online self-guided programs could be of great value when implementing such intervention into routine care.

Being tested
digital self-help

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • digital self-helpBehavioural

    Also called remainders

    The digital self-help program is targeting every-day ADHD symptoms in adults with a diagnosed ADHD

Study groups in NCT04511169
Study groupRoleWhat they receive
remainderExperimentalThe participants who are inactive for more than 48 hours after recieving new content will recieve a remainder, in the format of a text message and an email.
Receives: Behavioral: digital self-help
non-remainderNo interventionThe participants who are inactive for more than 48 hours after recieving new content will NOT recieve a remainder, in the format of a text message and an email.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. number of remainders

    number of remainders

    Measured: up to 8 weeks

Secondary outcomes (6)

  1. The Adult ADHD Self-Rating Scale

    includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5). ASRS is a self-report scale with 18 items, and is divided into two subscales; one scale measuring problems with Inattention (9 questions), and one scale measuring problems with Hyperactivity (9 questions). 0 to 16 means unlikely to have ADHD, 17 to 23 means likely to have ADHD, and 24 to 36 means highly likely to have ADHD

    Measured: up to 40 weeks

  2. Adult ADHD Quality of Life Measure

    Each item is rated by participant s on a five-point Likert scale ranging from "Not at all/ Never" (1) to "Extremely/Very Often" (5).

    Measured: up to 40 weeks

  3. The perceived stress scale

    The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress. Items were designed to measure stress and how uncontrollable respondents find their lives during the last month (Cohen et al, 1983). The PSS version used in this study has 10 items with response alternatives 0 (never) to 4 (very often) and an internal reliability of a Cronbach's alpha of 0.89 (Roberti et al, 2006)

    Measured: up to 40 weeks

  4. The Patient Health Questionnaire-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. Reliability and validity of the tool have indicated it has sound psychometric properties. Internal consistency of the PHQ-9 has been shown to be high

    Measured: up to 40 weeks

  5. The self-compassion scale - short form

    The scale includes 6 subscales that measure how often people respond to feelings of inadequacy or suffering with self-kindness, self-judgment, common humanity, isolation, mindfulness and over-identification. Questions are rated on a scale from 1 (almost never) to 5 (almost always).

    Measured: up to 40 weeks

  6. The Perceived Deficits Questionnaire 5-item

    brief assessment of subjective cognitive difficulties and covers problems with concentration (e.g. "trouble concentrating on things like watching a television program or reading a book?"), memory (e.g. "forget what you talked about after a telephone conversation?"), and executive functioning (e.g. "have trouble getting things organized?"). Every item is rated on a scale of 0 (Never) to 4 (Almost always) to yield a sum score of 0 to 20, with higher scores indicating greater severity of cognitive symptoms.

    Measured: up to 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2020
  2. Study start20 May 2020
  3. Primary completion20 Feb 2021
  4. Study completion1 Mar 2021

Resources

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
Sequential
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04511169
Sponsor's protocol ID
90483
Acronym
MINADHD
Status last verified
May 2020
First submitted
17 Jun 2020
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: we will share interaction data. not decided regarding health-related data

Publications

  • Nordby ES, Guribye F, Nordgreen T, Lundervold AJ. Silver linings of ADHD: a thematic analysis of adults' positive experiences with living with ADHD. BMJ Open. 2023 Oct 3;13(10):e072052. doi: 10.1136/bmjopen-2023-072052.

    PubMed 37788928

  • Kenter RMF, Schonning A, Inal Y. Internet-Delivered Self-help for Adults With ADHD (MyADHD): Usability Study. JMIR Form Res. 2022 Oct 21;6(10):e37137. doi: 10.2196/37137.

    PubMed 36269662

  • Nordby ES, Gjestad R, Kenter RMF, Guribye F, Mukhiya SK, Lundervold AJ, Nordgreen T. The Effect of SMS Reminders on Adherence in a Self-Guided Internet-Delivered Intervention for Adults With ADHD. Front Digit Health. 2022 May 16;4:821031. doi: 10.3389/fdgth.2022.821031. eCollection 2022.

    PubMed 35651537

  • Flobak E, Nordby ES, Guribye F, Kenter R, Nordgreen T, Lundervold AJ. Designing Videos With and for Adults With ADHD for an Online Intervention: Participatory Design Study and Thematic Analysis of Evaluation. JMIR Ment Health. 2021 Sep 14;8(9):e30292. doi: 10.2196/30292.

    PubMed 34519666

Questions about this trial

What is this clinical trial studying?

A study testing digital self-help in people with 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 3 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 25 Aug 2021. 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?

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?

number of remainders (time frame: up to 8 weeks). 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 NCT04511169, which also lists 4 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 25 Aug 2021.

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