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Clinical Trials/NCT04511169
NCT04511169
Completed
Not Applicable

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

Haukeland University Hospital1 site in 1 country100 target enrollmentMay 20, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ADHD - Combined Type
Sponsor
Haukeland University Hospital
Enrollment
100
Locations
1
Primary Endpoint
number of remainders
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 20, 2020
End Date
March 1, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Haukeland University Hospital
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

number of remainders

Time Frame: up to 8 weeks

number of remainders

Secondary Outcomes

  • Adult ADHD Quality of Life Measure(up to 40 weeks)
  • The Adult ADHD Self-Rating Scale(up to 40 weeks)
  • The self-compassion scale - short form(up to 40 weeks)
  • The perceived stress scale(up to 40 weeks)
  • The Patient Health Questionnaire-9(up to 40 weeks)
  • The Perceived Deficits Questionnaire 5-item(up to 40 weeks)

Study Sites (1)

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