An Internet-delivered Intervention for Coping With ADHD in Adulthood

NCT ID: NCT04726813

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-27
• Study Completion Date: 2021-12-20

Brief Summary

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.

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.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

a self-guided Internet delivered intervention

MinADHD: 7 self-help modules.

Group Type: EXPERIMENTAL

MyADHD

Intervention Type: 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.

Psycho-education

One self-guided psychoeducation module

Group Type: PLACEBO_COMPARATOR

Psychoeducation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Research Council of Norway

OTHER

Sponsor Role: collaborator

University of Bergen

OTHER

Sponsor Role: lead

Responsible Party

Robin Maria Francisca Kenter

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinical Psychology

Bergen, Vestland, Norway

Countries

Norway

References

Kenter RMF, Gjestad R, Lundervold AJ, Nordgreen T. A self-guided internet-delivered intervention for adults with ADHD: Results from a randomized controlled trial. Internet Interv. 2023 Mar 20;32:100614. doi: 10.1016/j.invent.2023.100614. eCollection 2023 Apr.

Reference Type: DERIVED

PMID: 36969389 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34877262 (View on PubMed)

Other Identifiers

203804

Identifier Type: -

Identifier Source: org_study_id