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Completed

NCT Number: NCT04511169

MyADHD-digital Training for Adults With ADHD

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.

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Key information

Conditions

ADHD - Combined Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Sample

Bergen, 5000, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults with a diagnosis of ADHD
  • Access to a computer, smartphone and the Internet.
  • Speaks, writes and read Norwegian

Exclusion criteria

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

Treatment and study plan

digital self-help

Behavioral

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

Other names: remainders

Primary outcomes

  1. number of remainders

    Time frame: up to 8 weeks

    number of remainders

Secondary outcomes

  1. The Adult ADHD Self-Rating Scale

    Time frame: up to 40 weeks

    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

  2. Adult ADHD Quality of Life Measure

    Time frame: up to 40 weeks

    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).

  3. The perceived stress scale

    Time frame: up to 40 weeks

    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)

  4. The Patient Health Questionnaire-9

    Time frame: up to 40 weeks

    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

  5. The self-compassion scale - short form

    Time frame: up to 40 weeks

    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).

  6. The Perceived Deficits Questionnaire 5-item

    Time frame: up to 40 weeks

    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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • University of Bergen

Registry information

Official study title

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

Acronym: MINADHD

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 13, 2020
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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