An interventional study of Group CBT based on DBT-skills training and Activity group in ADHD, sponsored by Region Stockholm. Recruiting at 2 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Region Stockholm · Not applicable, Interventional, and Treatment
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:
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:
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.
1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.
This study's planned enrollment of 120 is above the median of 71 across 1,437 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Region Stockholm is the lead sponsor of 121 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: 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.
Time frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
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.
Time frame: 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).
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)
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%).
Time frame: Baseline, at 14 weeks after end of treatment and after 6, 12 and 24 months
Treatment Credibility questionnaire (TCS)
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.
Time frame: After two sessions of CBT/activity group have been administered.
Negative Effects Questionnaire (NEQ)
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.
Time frame: Between 1-3 months after the last of the 14th weekly intervention session, at one occasion
Plan to share: Undecided — IPD consist partially of data in medical records and can at this stage not be shared other than at group level
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2028, 27 months after the start.
Of 479 non-industry interventional studies with no phase under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 27 months is above that.
Counting every sponsor, half of 510 studies reached it within 23 months; a quarter within 11 and three quarters within 41.
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