NCT04726813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 27, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 27, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

June 15, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

January 8, 2021

Last Update Submit

June 14, 2022

Conditions

Keywords

ADHDRCTInternet-delivered interventionSelf-helpCoping

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • The perceived stress scale (PSS)

    Change in stress symptoms at 8 weeks

  • The Patient Health Questionnaire-9 (PHQ-9)

    Change in depression symptoms at 8 weeks

Other Outcomes (2)

  • Adherence

    immediately after the intervention

  • User satisfaction

    immediately after the intervention

Study Arms (2)

a self-guided Internet delivered intervention

EXPERIMENTAL

MinADHD: 7 self-help modules.

Behavioral: MyADHD

Psycho-education

PLACEBO COMPARATOR

One self-guided psychoeducation module

Behavioral: Psychoeducation

Interventions

MyADHDBEHAVIORAL

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.

a self-guided Internet delivered intervention
PsychoeducationBEHAVIORAL

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.

Psycho-education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Psychology

Bergen, Vestland, Norway

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

January 8, 2021

First Posted

January 27, 2021

Study Start

April 27, 2021

Primary Completion

October 20, 2021

Study Completion

December 20, 2021

Last Updated

June 15, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations