Internet-based Cognitive Behavioral Therapy for Adult Attention Deficit Hyperactivity Disorder

NCT ID: NCT05700539

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2025-12-31

Brief Summary

Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by lack of attention, hyperactivity, and impulsivity. It can have major impact on everyday life and result in negative consequences for one's personal, academic, and work situation. For individuals with symptoms of ADHD, increased levels of anxiety and depression are common, and an overall reduction of quality of life is often present. This study protocol describes a clinical trial of internet-based cognitive behavioral therapy (iCBT), using a randomized controlled study design, with the primary aim to increase quality of life, as well as to reduce symptoms of ADHD, anxiety, depression, and stress. A second aim is to investigate, by qualitative means, what aspects of treatment were perceived as helpful and hindering when it comes to completing iCBT. Two hundred participants with symptoms of ADHD will be included and randomized to two conditions (treatment and wait-list control). The treatment period is comprised of ten weeks, with two mandatory modules and ten modules from which the participants can choose freely. Self-report measures are completed by the participants at baseline and end of treatment, as well as at a six-month follow-up. The treatment is guided by therapists and consists of weekly correspondence with the participants. The study will utilize an intention to treat design, with ANOVAs and Reliable Change Index to evaluate treatment effects. The qualitative part of the project will be interview-based and employ thematic analysis. Lastly, a psychometric evaluation of a common instrument for determining ADHD-symptoms will also be made. The results will hopefully contribute to the evidence base for iCBT for individuals with symptoms of ADHD and help disseminate potentially effective interventions.

Conditions

ADHD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based cognitive behavioral therapy

Group Type: EXPERIMENTAL

Internet-based cognitive behavioral therapy

Intervention Type: BEHAVIORAL

A ten-week treatment based on cognitive behavioral therapy for ADHD, including two mandatory modules and at least four self-selected modules (out of ten available modules). The treatment consists of reading material and exercises to be completed each week.

Wait-list control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-based cognitive behavioral therapy

A ten-week treatment based on cognitive behavioral therapy for ADHD, including two mandatory modules and at least four self-selected modules (out of ten available modules). The treatment consists of reading material and exercises to be completed each week.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Over 18 years old of age.

2. Can read and write in Swedish.

3. Have access to a computer, tablet, or smartphone with an Internet connection.

4. Have previously been diagnosed with ADHD.

5. Are studying at a university or college in Sweden or working at least 50% of a full time-employment.

Exclusion Criteria

1. Shows elevated symptoms of depression or risk of suicide, i.e., a total score on the Patient Health Questionnaire - 9 items (PHQ-9; Kroenke, K., Spitzer, R. L., & Williams, J. B. (2001)), > 15 points, or scores > 2 points on question i) concerning suicidality.

2. Has started or changed their medication for any psychiatric diagnosis in the last three months.

3. Exhibits another form of psychiatric diagnosis that requires more specialized care, for example substance abuse syndrome, anorexia nervosa, bipolar disorder, psychotic symptoms, or schizophrenia, as assessed with the MINI (Sheehan et al., 1998).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Uppsala University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Alexander Rozental

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Forsström, PhD

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala University

Uppsala, , Sweden

Site Status: RECRUITING

Countries

Sweden

Central Contacts

Alexander Rozental, PhD

Role: CONTACT

alexander.rozental@ki.se

+46(0)736937948

Monica Buhrman, PhD

Role: CONTACT

monica.buhrman@psyk.uu.se

+46(0)733468539

Facility Contacts

David Forsström, PhD

Role: primary

Other Identifiers

DF0001

Identifier Type: -

Identifier Source: org_study_id