A Comparison of Group Cognitive Behavioural Therapy (CBT) and Structured Activity Group for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Controlled Clinical Trials of Commonly Used Psychological Treatments for Adults With Neurodevelopmental Disorder (NDD)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Despite pharmacological treatment, many adults with ADHD experience residual symptoms that negatively affect work performance and social life. Hence, several psychological interventions targeting these symptoms have been developed, but the treatment effects are still unclear due to lack of controlled clinical trials.
In this single-blind randomised controlled clinical trial, we will evaluate the effects of group CBT compared to an active control group. The group CBT is based on the Swedish version of the Dialectical Behavior Therapy (DBT) skills training program developed by Bernd Hesslinger. The control intervention is a manualised activity group that contains the same non-specific therapeutic elements as the treatment but no active CBT components. For dose equivalence, activity groups will be given with the same number and length of sessions, and the same frequency, as the treatment conditions. Since therapist experience is known to influence outcomes, the activity groups will be held by staff with equivalent training and experience to those giving the treatment groups.
Consenting patients assessed eligible for treatment will be randomly assigned to treatment or control group using a standard digital randomisation generator with an allocation of 1:1. Patients and clinicians rating outcomes will be blind to group assignment.
Pre- and post intervention, and at 6 months, 12 months and 24 months follow-up, the patient's ADHD symptoms, symptoms of anxiety and depression and general functioning will be assessed by experienced clinicians and with validated self-rating scales. Treatment fidelity and expectation will be compared for the therapy and control groups and adverse events will be registered by clinicians and assessed with a self-rating scale.
An exact power calculation for estimation of sample sizes cannot be performed since effect sizes are not known. Based on a previously published studies of CBT treatment effect, and general consensus of what is a clinically meaningful improvement in psychological treatments for other psychiatric diagnoses, we expect that 60 patients per arm will be sufficient for detection of clinically relevant effect sizes of approximately Cohen's d 0.3-0.4. A statistician will make a blind Bayesian stop analysis for every 20-25 patients, and based on the results we can decide to halt the study if sufficient power has been achieved earlier than after 60 patients. Full attrition analysis with intention to treat (ITT) analysis will be performed to investigate and minimize attrition bias.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jacqueline Borg, PhD
- Phone Number: 46733248024
- Email: jacqueline.borg@ki.se
Study Contact Backup
- Name: Helena Löfgren
- Email: jacqueline.borg@ki.se
Study Locations
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Stockholm, Sweden
- Recruiting
- Centre for Psychiatry Research
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Contact:
- Jacqueline Borg, PhD
- Phone Number: +46733248024
- Email: jacqueline.borg@ki.se
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Fulfilling criteria for ADHD
- Motivation and practical possibility to participate in the treatment.
Exclusion Criteria:
- Ongoing psychosis
- Ongoing suicidality/severe self-injury
- Intellectual disability
- Insufficient Swedish language skills.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group CBT based on DBT-skills training
Group CBT based on the Swedish version of Hesslinger's DBT skills training for adults with ADHD |
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. |
|
Active Comparator: Activity group
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Adult ADHD Self-Report Scale (ASRS)
Time Frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
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)
Time Frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
Time Frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
CORE-OM is a self-rating questionnaire covering general psychiatric symptoms, well-being and functioning. It has 34 questions about how often the participant experiences a certain symptom, with five response choices ranging from 0 (not at all) to 4 (most or all of the time) points. |
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
|
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time Frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
BBQ is a validated brief version of the self-rating Quality of Life Scale, with higher sensitivity to change. It consists of 12 statements and the participant indicates how much they agree with each statement in five response choices ranging from 0 (do not agree at all) to 4 (agree completely). |
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
|
Difficulties in Emotion Regulation Scale, brief version (DERS-16)
Time Frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
DERS-16 is a validated brief version of the original 36 item self-assessment measuring clinically relevant difficulties in emotional regulation. DERS-16 consists of 16 questions about how often a statement applies to the participant, with five response choices ranging from 1-5 where 1 is almost never (0-10% of the time) and 5 is almost always (91-100%). |
Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Credibility questionnaire (TCS)
Time Frame: After two sessions of CBT/activity group have been administered.
|
Swedish version of the TCS for assessment of treatment fidelity and expectation in both participants with ADHD and clinicians administering the CBT and activity groups. |
After two sessions of CBT/activity group have been administered.
|
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Negative Effects Questionnaire (NEQ)
Time Frame: Between 1-3 months after the last of the 14th weekly intervention session, at one occasion
|
A self-report measure for assessment of adverse events associated with psychological treatment. The 20 item version will be used, and participants rate a statement ranging from 0-4 where 0 is not at alls and 4 is extremely. |
Between 1-3 months after the last of the 14th weekly intervention session, at one occasion
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jacqueline Borg, PhD, Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SLSO 2026-3477
- 2023 (U.S. NIH Grant/Contract)
- 2023-01505 (Other Grant/Funding Number: Forte)
- FoUI-1023740 (Other Grant/Funding Number: Region Stockholm)
- EPM Dnr 2026-00346-01 (Other Identifier: Swedish Ethical Review Authority)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD consist partially of data in medical records and can at this stage not be shared other than at group level
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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