ADHDNCT07834437
A Comparison of Group Cognitive Behavioural Therapy (CBT) and Structured Activity Group for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Group CBT based on DBT-skills training and Activity group in people with ADHD, run by Region Stockholm at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHD
- What is being tested?
- Group CBT based on DBT-skills training and Activity group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Sep 2026to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilling criteria for ADHD
- Motivation and practical possibility to participate in the treatment.
Who cannot join
- Ongoing psychosis
- Ongoing suicidality/severe self-injury
- Intellectual disability
- Insufficient Swedish language skills.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Helena Löfgren contact
Sweden2 sites, 2 recruiting
- Recruiting
Centre for Psychiatry Research
Stockholm
- Recruiting
Centre for Psychiatry Research
Stockholm
Jacqueline Borg, PhD, +46733248024, jacqueline.borg@ki.se
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Conditions
- ADHD
- Being tested
- Group CBT based on DBT-skills training, Activity group
- Keywords
- Attention Deficit Hyperactivity Disorder, Cognitive Behaviour Therapy, Dialectical Behavior Therapy, Group Psychotherapy, Randomized Controlled Trial
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group CBT based on DBT-skills trainingBehavioural
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.
Activity groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Behavioral: Activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
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.
Measured: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
Brunnsviken Brief Quality of Life Inventory (BBQ)
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).
Measured: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
Difficulties in Emotion Regulation Scale, brief version (DERS-16)
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%).
Measured: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Sep 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Region StockholmThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jacqueline Borg, Region Stockholm
- Investigators
- Jacqueline Borg, PhD, Principal investigator, Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834437
- Sponsor's protocol ID
- SLSO 2026-3477
- Other IDs
- 2023-01505, FoUI-1023740, EPM Dnr 2026-00346-01, 2023
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD consist partially of data in medical records and can at this stage not be shared other than at group level
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Clinical Trials of Commonly Used Psychological Treatments for Adults With Neurodevelopmental Disorder (NDD)
- ClinicalTrials.gov ID
- NCT07834437
- Acronym / sponsor ID
- SLSO 2026-3477
- Conditions
- ADHD
- Keywords
- Attention Deficit Hyperactivity Disorder, Cognitive Behaviour Therapy, Dialectical Behavior Therapy, Group Psychotherapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group CBT based on DBT-skills training | Experimental | Behavioral: Group CBT based on DBT-skills trainingGroup CBT based on the Swedish version of Hesslinger's DBT skills training for adults with ADHD |
| Activity group | Active comparator | Behavioral: Activity groupThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fulfilling criteria for ADHD
- Motivation and practical possibility to participate in the treatment.
Key exclusion criteria (4 listed)
- Ongoing psychosis
- Ongoing suicidality/severe self-injury
- Intellectual disability
- Insufficient Swedish language skills.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group CBT based on DBT-skills trainingThe 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. | Behavioural | Group CBT based on DBT-skills training |
| Activity groupThe 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. | Behavioural | Activity group |
Primary outcome
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.
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.
3 secondary outcomes
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
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Individual participant dataSharing planned: Undecided. IPD consist partially of data in medical records and can at this stage not be shared other than at group level
Related trials for ADHD
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helena Löfgren contact
Jacqueline Borg, PhD principal investigator
Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group CBT based on DBT-skills training and Activity group in people with ADHD, run by Region Stockholm at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqueline Borg, PhD (46733248024, jacqueline.borg@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.