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Completed

NCT Number: NCT04726813

An Internet-delivered Intervention for Coping With ADHD in Adulthood

The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Psychology

Bergen, Vestland, Norway

About this study

ADHD in adulthood, with an estimated prevalence of 2 - 3 %, is associated with challenges in daily life functioning. The availability of evidence-based psychological interventions for adults with ADHD is poor. Interventions delivered over the Internet might help to increase the availability of effective psychological interventions for this group. The primary aim of this study is to examine the efficacy of a self-guided Internet-delivered intervention for coping with ADHD. The secondary aim is to investigate the effects of individual adaptation of the intervention on adherence, satisfaction and clinical outcomes. A minimum of 118 participants with a self-reported ADHD diagnosis will be included in the study. In phase 1 we will conduct a randomized controlled trial with two arms, 1) self-guided Internet-delivered intervention for coping with ADHD (N=59), 2) self-guided online psychoeducation (control group, N= 59), with a 3 month follow-up. After 3 months the second phase of the study starts. In this phase (II) the control group participants will receive an adaptive version of the Internet-delivered intervention. This includes adaptation of the order of the modules to the individual participant needs, with the use of rule-based and machine-learning based adaptation. Clinical outcomes in both phases are inattention, hyperactivity, quality of life and stress. Uptake, usage, adherence and satisfaction will be explored. Repeated measurers are at baseline, weekly during the intervention period, post-intervention and 3 months follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults with a self-reported diagnosis of ADHD (date, venue and diagnosing physician)
  • Access to and ability to use a computer, smartphone and the Internet.
  • Current problems with organizing daily activity and 17 points of more on at least one of the ASRS subscales
  • Participant are by investigators considered able to follow through the training protocol and take part in measures taken during the study time frame
  • Speaks, writes and reads Norwegian

Exclusion criteria

  • Current self-reported diagnosis of severe psychiatric illness such as borderline or antisocial personality disorder, bipolar disorder, ongoing substance abuse, and/or suicidal ideation assessed with item 9 on the MADRS
  • Participants who are taking prescribed ADHD medication have to be stable on the medication at least four weeks before the study and during the study.

Treatment and study plan

MyADHD

Behavioral

The main goals of the intervention are to help participants with better functioning in daily life; offer strategies that will lead to stress reduction and reduce inattention and improve quality of life.The intervention includes: a short introductory chapter (open to everyone), followed by a start module (goal setting), followed by 6 different themed optional modules. Module content is based on GMT, DBT and CBT techniques and is tailored towards key concerns and difficulties experienced adults with ADHD as informed by previous research (focus-groups, lived experience groups) and experiences from group GMT and DBT.

Psychoeducation

Behavioral

Participants in the control condition will be assigned to psychoeducation modules (see Table 2) and will receive restricted access to the platform. They can contact or be contacted if their symptoms levels increases.

Primary outcomes

  1. The Adult ADHD Self-Rating Scale (ASRS)

    Time frame: Change in ADHD symptoms at 8 weeks

    The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).

  2. Adult ADHD Quality of Life Measure (AAQol)

    Time frame: Change in quality of life at 8 weeks

    The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.

Secondary outcomes

  1. The perceived stress scale (PSS)

    Time frame: Change in stress symptoms at 8 weeks

    The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress.

  2. The Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Change in depression symptoms at 8 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

Other outcomes

  1. Adherence

    Time frame: immediately after the intervention

    Usage outcomes of interest are attrition and adherence to the intervention.

  2. User satisfaction

    Time frame: immediately after the intervention

    Four open end questions at the end of the modules:

    • Were there parts of the module that you experienced as helpful and/or supportive?
    • Were there parts of the module that you experienced as complicated and/or unhelpful?
    • Would you recommend this module to a friend or a family member with similar difficulties as yourself?
    • How useful did you find this module? 1-10

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

An Internet-delivered Intervention for Coping With ADHD in Adulthood - a Randomized Controlled Trial

Acronym: MyADHD

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2021
Registry last updated
Jun 15, 2022

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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