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

ADHD Clinical Trial

— MinADHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06299189
• Other study ID #: 309264
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: September 2027

Study information

• Verified date: March 2024
• Source: Haukeland University Hospital
• Contact: Aleksander Heltne
• Phone: 00000000
• Email: aleksander.gulla.heltne[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2027
• Est. primary completion date: September 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• ADHD - Combined Type
• ADHD Predominantly Inattentive Type
• ADHD, Predominantly Hyperactive - Impulsive
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Intervention

Behavioral:
• MinADHD
Guided self-help, 7 modules Interventions

Locations

Country	Name	City	State
Norway	Bjørgvin DPS	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Adult ADHD Self-Rating Scale	Measure of ADHD symptom severity	From enrollment to the end of 6-months follow-up
Primary	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	The Patient Health Questionnaire	Measure of depression	From enrollment til the end of 6-month follow-up.
Secondary	Generalized Anxiety Disorder-7	Measure of anxiety	From enrollment til the end of 6-month follow-up.
Secondary	Personality Disorder Severity ICD-11	Measure of personality functioning	From enrollment til the end of 6-month follow-up.
Secondary	EuroQoL 5D-5L	Measure of health-related quality of life	From enrollment to end of 6-month follow-up.