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Clinical Trials/NCT04726813
NCT04726813
Completed
N/A

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

University of Bergen1 site in 1 country120 target enrollmentApril 27, 2021
ConditionsADHD

Overview

Phase
N/A
Intervention
Not specified
Conditions
ADHD
Sponsor
University of Bergen
Enrollment
120
Locations
1
Primary Endpoint
Adult ADHD Quality of Life Measure (AAQol)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 27, 2021
End Date
December 20, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robin Maria Francisca Kenter

Principal investigator

University of Bergen

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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).

Secondary Outcomes

  • 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)

Study Sites (1)

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