An Internet-delivered Intervention for Coping With ADHD in Adulthood (MyADHD)

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

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Behavioral: MyADHD; Behavioral: Psychoeducation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway
      • Clinical Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

5. Speaks, writes and reads Norwegian

   Exclusion Criteria:

6. 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
7. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: a self-guided Internet delivered intervention; MinADHD: 7 self-help modules.	Behavioral: MyADHD; 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.
Placebo Comparator: Psycho-education; One self-guided psychoeducation module	Behavioral: Psychoeducation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Adult ADHD Self-Rating Scale (ASRS)	The Adult ADHD Self-Rating Scale (ASRS) includes all the 18 symptoms of ADHD included in the diagnostic manual (DSM-5).	Change in ADHD symptoms at 8 weeks
Adult ADHD Quality of Life Measure (AAQol)	The AAQoL has 29 items designed to assess HRQL during the past two weeks among adults with ADHD.	Change in quality of life at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The perceived stress scale (PSS)	The Perceived Stress Scale (PSS) is a widely used psychological instrument for measuring stress.	Change in stress symptoms at 8 weeks
The Patient Health Questionnaire-9 (PHQ-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	Change in depression symptoms at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Usage outcomes of interest are attrition and adherence to the intervention.	immediately after the intervention
User satisfaction	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	immediately after the intervention

Collaborators and Investigators

• Sponsor: University of Bergen
• Collaborators: The Research Council of Norway

Publications and helpful links

General Publications

• Kenter RMF, Lundervold AJ, Nordgreen T. A self-guided Internet-delivered intervention for adults with ADHD: a protocol for a randomized controlled trial. Internet Interv. 2021 Nov 20;26:100485. doi: 10.1016/j.invent.2021.100485. eCollection 2021 Dec.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): October 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 25, 2021
• First Posted (Actual): January 27, 2021

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ADHD; RCT; Self-help; Coping; Internet-delivered intervention
• Other Study ID Numbers: 203804

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No