Clinical trial NCT04511169: MyADHD-digital Training for Adults With ADHD
Official title: A Self-guided Internet-delivered Intervention for Adults With ADHD: Study Protocol for a Micro-randomized Trial Investigating the Use of Reminders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD - Combined Type
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: University of Bergen
First posted: 2020-08-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of remainders
timeFrame: up to 8 weeks
Secondary outcomes:
measure: The Adult ADHD Self-Rating Scale
timeFrame: up to 40 weeks
measure: Adult ADHD Quality of Life Measure
timeFrame: up to 40 weeks
measure: The perceived stress scale
timeFrame: up to 40 weeks
measure: The Patient Health Questionnaire-9
timeFrame: up to 40 weeks
measure: The self-compassion scale - short form
timeFrame: up to 40 weeks
measure: The Perceived Deficits Questionnaire 5-item
timeFrame: up to 40 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Community Sample
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.