A Therapist Guided Internet-delivered Treatment for Adults With ADHD (Attention Deficit / Hyperactivity Disorder) - an Open Effectiveness Trial in Routine Care (MinADHD)

A Therapist Guided Internet-delivered Treatment for Adults With ADHD - an Open Effectiveness Trial in Routine Care

The primary objective of this study is to explore and evaluate the use and utility of a guided Internet-delivered psychological treatment for adults with ADHD with a combined focus on:

i) Evaluating the impact of potential predictors to treatment adherence, treatment response, treatment use and utilty. ii) Evaluating the feasibility, clinical benefits and implementation process of the treatment in routine outpatient care. iii) Evaluate the cost-effectiveness of the treatment program.

Study Overview

• Status: Recruiting
• Conditions: ADHD; ADHD Predominantly Inattentive Type; ADHD - Combined Type; ADHD, Predominantly Hyperactive - Impulsive
• Intervention / Treatment: Behavioral: MinADHD

Detailed Description

Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterized by symptoms of inattention and/or hyperactivity/impulsivity that are persistent across time and situations. ADHD in adulthood, with estimated prevalence of 2-3%, is associated with challenges that may have severe consequences on daily life functioning. Treatments delivered over the Internet on smartphones or personal computers may help to increase the availability of effective psychological interventions for a larger group of adults with ADHD. The overall aim of this study is to investigate 1) predictors of effect; 2) implementation outcomes; and the 3) cost-benefit of a therapist guided Internet-delivered treatment for adults with an ADHD diagnosis. The study is an open longitudinal cohort trial in routine care. A total of 200 participants with an ADHD diagnosis will be included in the trial, and 15 participants will be interviewed about their experiences with guided Internet-delivered treatment. The outcomes are change in primary and secondary symptoms and quality of life, cost-benefit and implementation outcomes of guided internet-delivered treatment for adults with ADHD. The investigators will use quantitative statistical procedures and qualitative methods to analyze the data. The results from the study will contribute to the growing research on Internet-delivered treatments. The expected results may have a major impact on treatment provision and the further development of treatment options for adults with ADHD. Moreover, investigating ways to increase adoption, adherence and fidelity in Internet-delivered treatment could be of great value when implementing such treatment into routine care.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksander Heltne; Phone Number: 00000000; Email: aleksander.gulla.heltne@helse-bergen.no
• Study Contact Backup: Name: Tine Nordgreen; Phone Number: 00000000; Email: tine.nordgreen@helse-bergen.no

Study Locations

• Norway
  • Bergen, Norway
    • Recruiting
    • Bjørgvin DPS
    • Contact: Gunn Elise Sæthre; Phone Number: 00000000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria: |

• Age ≥18
• A self-reported diagnosis of ADHD
• Access to and ability to use a computer, smartphone and the Internet.
• Speaks, writes and reads Norwegian

Exclusion criteria:

• In need of other psychological treatment for mental health illness such as borderline or personality disorder, bipolar disorder, substance abuse or psychosis.
• Ongoing psychological treatment for ADHD or other psychiatric illnesses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A self-guided internet delivered intervention; MinADHD: 7 self-help modules Interventions: Behavioural	Behavioral: MinADHD; Guided self-help, 7 modules Interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Adult ADHD Self-Rating Scale	Measure of ADHD symptom severity	From enrollment to the end of 6-months follow-up
Adult ADHD Quality of Life Measure	Measure of impact of ADHD on quality of life	From enrollment til the end of 6-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Patient Health Questionnaire	Measure of depression	From enrollment til the end of 6-month follow-up.
Generalized Anxiety Disorder-7	Measure of anxiety	From enrollment til the end of 6-month follow-up.
Personality Disorder Severity ICD-11	Measure of personality functioning	From enrollment til the end of 6-month follow-up.
EuroQoL 5D-5L	Measure of health-related quality of life	From enrollment to end of 6-month follow-up.

Collaborators and Investigators

• Sponsor: Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 28, 2024
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 7, 2024

Study Record Updates

• Last Update Posted (Estimated): August 26, 2025
• Last Update Submitted That Met QC Criteria: August 25, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: 309264 (Research Council of Norway)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The IPD collected for the current trial is considered sensitive patient information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No