NCT04511169

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

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

Study Start

First participant enrolled

May 20, 2020

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 13, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2021

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

August 25, 2021

Status Verified

May 1, 2020

Enrollment Period

9 months

First QC Date

June 17, 2020

Last Update Submit

August 24, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of remainders

    number of remainders

    up to 8 weeks

Secondary Outcomes (6)

  • The Adult ADHD Self-Rating Scale

    up to 40 weeks

  • Adult ADHD Quality of Life Measure

    up to 40 weeks

  • The perceived stress scale

    up to 40 weeks

  • The Patient Health Questionnaire-9

    up to 40 weeks

  • The self-compassion scale - short form

    up to 40 weeks

  • +1 more secondary outcomes

Study Arms (2)

remainder

EXPERIMENTAL

The participants who are inactive for more than 48 hours after recieving new content will recieve a remainder, in the format of a text message and an email.

Behavioral: digital self-help

non-remainder

NO INTERVENTION

The participants who are inactive for more than 48 hours after recieving new content will NOT recieve a remainder, in the format of a text message and an email.

Interventions

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

Also known as: remainders
remainder

Eligibility Criteria

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

You may qualify if:

  • Adults with a diagnosis of ADHD
  • Access to a computer, smartphone and the Internet.
  • Speaks, writes and read Norwegian

You may not qualify if:

  • Current self-reported diagnosis of severe psychiatric illness (ongoing substance abuse, suicidal ideation or psychosis).
  • Ongoing psychological treatment for ADHD or other psychiatric illnesses.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Sample

Bergen, 5000, Norway

Location

Related Publications (4)

  • Nordby ES, Guribye F, Nordgreen T, Lundervold AJ. Silver linings of ADHD: a thematic analysis of adults' positive experiences with living with ADHD. BMJ Open. 2023 Oct 3;13(10):e072052. doi: 10.1136/bmjopen-2023-072052.

  • Kenter RMF, Schonning A, Inal Y. Internet-Delivered Self-help for Adults With ADHD (MyADHD): Usability Study. JMIR Form Res. 2022 Oct 21;6(10):e37137. doi: 10.2196/37137.

  • Nordby ES, Gjestad R, Kenter RMF, Guribye F, Mukhiya SK, Lundervold AJ, Nordgreen T. The Effect of SMS Reminders on Adherence in a Self-Guided Internet-Delivered Intervention for Adults With ADHD. Front Digit Health. 2022 May 16;4:821031. doi: 10.3389/fdgth.2022.821031. eCollection 2022.

  • Flobak E, Nordby ES, Guribye F, Kenter R, Nordgreen T, Lundervold AJ. Designing Videos With and for Adults With ADHD for an Online Intervention: Participatory Design Study and Thematic Analysis of Evaluation. JMIR Ment Health. 2021 Sep 14;8(9):e30292. doi: 10.2196/30292.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The assessor do not know if the participant is randomized to remainders or not
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2020

First Posted

August 13, 2020

Study Start

May 20, 2020

Primary Completion

February 20, 2021

Study Completion

March 1, 2021

Last Updated

August 25, 2021

Record last verified: 2020-05

Locations