A Comparison of Group Cognitive Behavioural Therapy (CBT) and Structured Activity Group for Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT07834437 | Recruiting

• 5 other identifiers: SLSO 2026-34772023-01505FoUI-1023740EPM Dnr 2026-00346-012023
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

Many adults with attention deficit hyperactivity disorder (ADHD) experience difficulties with inattention, planning, impulsivity and emotion regulation that impacts work and social life negatively also after treatment with medication. There are various psychological treatments aiming to improve these symptoms, but it is not known if they work or not. The goal of this clinical trial is to evaluate group cognitive behavioural therapy (CBT) for adults with attention deficit hyperactivity disorder (ADHD) in comparison to an active control group consisting of a discussion and activity group. Previous research suggests that group CBT works about equally well as other structured group activities. The main questions the researchers aim to answer are if group CBT work better than activity groups to:

• Improve symptoms of ADHD
• Improve general mental health and life quality
• Improve every-day functioning The researchers also want to learn if group CBT or activity groups work better for some people with ADHD depending on individual characteristics such as
• Type of symptoms, age, gender or co-occurring psychiatric diagnoses The comparison is a manualised structured activity group given at the same number of sessions and same group size. All participants will visit our clinics at 14 occasions. They will:
• Fill in questionnaires before and after the group intervention, and online after 6, 12 and 24 months
• Do an interview with an independent trained clinician about their daily functioning and difficulties related to ADHD symptoms before and after the group intervention, and after 6, 12 and 24 months

Conditions

ADHD

Keywords

Attention Deficit Hyperactivity Disorder; Cognitive Behaviour Therapy; Dialectical Behavior Therapy; Group Psychotherapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Change in Adult ADHD Self-Report Scale (ASRS)

  ASRS is a self-reported symptom questionnaire for adults with ADHD. It has 18 questions about how often the participant experiences a certain symptom, with five response choices ranging from 0 (never) to 4 (very often) points.

  Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

• Change in Clinical Global Impressions-Severity (CGI-S)

  CGI-S is a 7-point scale where the clinician rate the severity of the patients illness at the time of assessment.

  Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

Secondary Outcomes (3)

• Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)

  Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

• Brunnsviken Brief Quality of Life Inventory (BBQ)

  Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

• Difficulties in Emotion Regulation Scale, brief version (DERS-16)

  Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months

Other Outcomes (2)

• Treatment Credibility questionnaire (TCS)

  After two sessions of CBT/activity group have been administered.

• Negative Effects Questionnaire (NEQ)

  Between 1-3 months after the last of the 14th weekly intervention session, at one occasion

Study Arms (2)

Group CBT based on DBT-skills training

EXPERIMENTAL

Group CBT based on the Swedish version of Hesslinger's DBT skills training for adults with ADHD

Behavioral: Group CBT based on DBT-skills training

Activity group

ACTIVE COMPARATOR

The Activity group is a structured manualised group intervention designed by clinicians and researchers at Sahlgrenska University Hospital specifically to serve as an active control intervetion to CBT.

Behavioral: Activity group

Interventions

Group CBT based on DBT-skills training BEHAVIORAL

The Swedish version manual of Hesslinger's DBT-based skills training for adults with ADHD. The program includes psychoeducation, skills training and mindfulness exercises and aims to improve ADHD symptoms, especially disorganised and dysfunctional behaviour, emotion dysregulation and impulse control. The skills training group will meet at the clinic weekly for 14 weeks for 2 hours including a break in the middle. The groups are led by two clinicians.

Group CBT based on DBT-skills training

Activity group BEHAVIORAL

The Activity group is a structured manualised group intervention designed for this as well as prior and planned future studies of psychosocial treatments for adults with ADHD and/or autism. The program includes group discussions, peer-sharing and social every-day life activities. The Activity groups will meet at the clinic weekly for 14 weeks for 2 hours including a break in the middle. The groups are led by two trainers.

Activity group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfilling criteria for ADHD
• Motivation and practical possibility to participate in the treatment.

You may not qualify if:

• Ongoing psychosis
• Ongoing suicidality/severe self-injury
• Intellectual disability
• Insufficient Swedish language skills.

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (2)

Centre for Psychiatry Research

Stockholm, Sweden

RECRUITING

Centre for Psychiatry Research

Stockholm, Sweden

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jacqueline Borg, PhD

  Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Borg, PhD

CONTACT

46733248024; jacqueline.borg@ki.se

Helena Löfgren

CONTACT

jacqueline.borg@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist, PhD

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 22, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 22, 2026

Record last verified: 2026-09

Locations

SE (2)