MyADHD-digital Training for Adults With ADHD

ADHD - Combined Type Clinical Trial

— MINADHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04511169
• Other study ID #: 90483
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2020
• Source: Haukeland University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: February 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ADHD - Combined Type

Intervention

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

Locations

Country	Name	City	State
Norway	Community Sample	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of remainders	number of remainders	up to 8 weeks
Secondary	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	up to 40 weeks
Secondary	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).	up to 40 weeks
Secondary	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)	up to 40 weeks
Secondary	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	up to 40 weeks
Secondary	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).	up to 40 weeks
Secondary	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.	up to 40 weeks