Attention Deficit Hyperactivity Disorder (ADHD)NCT06604845
A Comparison of Group Cognitive Behavioural Therapy (CBT) and Structured Activity Group for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A study testing Group cognitive behavioural therapy (CBT) and Activity group in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Vastra Gotaland Region at 1 site in Sweden.
Trial summary
Many adults with attention deficit hyperactivity disorder (ADHD) experience difficulties with inattention, planning and impulsivity 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
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Group cognitive behavioural therapy (CBT) and Activity group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSweden
- Study dates
- 10 Sep 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 or suicidality, severe self-injury,
- Intellectual disability
- Insufficient Swedish language skills.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind Randomised Controlled Trial of Group Cognitive Behavioural Therapy (CBT) Versus Activity Group Control Condition for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Many adults with attention deficit hyperactivity disorder (ADHD) experience difficulties with inattention, planning and impulsivity 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 12 occasions. The partipants will:
- Fill in questionnaires before and after the group intervention, and online after 6 and 12 months
- Do cognitive testing before and after the intervention
Read the detailed description
Despite medical 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, the reseachers will evaluate the effects of group CBT based on Safren's manual "CBT for ADHD/Mastering Your Adult ADHD" compared to an active control group. 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 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 and 12 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.
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 Safren's CBT individually administered, 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.
- Being tested
- Group cognitive behavioural therapy (CBT), Activity group
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Cognitive Behavioral Therapy, Controlled Clinical Trials, Randomized, Adults
- 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 cognitive behavioural therapy (CBT)Behavioural
CBT based on Safren's manual "CBT for ADHD/Mastering Your Adult ADHD"20 adapted for group format. The program includes psychoeducation and cognitive restructuring and aims to improve ADHD symptoms, especially planning, organisation, attention and adaptive thinking. The CBT groups will meet at the clinic weekly for 12 weeks for 2 hours including a break in the middle. The groups are led by two clinicians.
Activity groupOther
The Activity group is a structured manualised group intervention designed for this 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 12 weeks for 2 hours including a break in the middle. The groups are led by two trainers.
| Study group | Role | What they receive |
|---|---|---|
| Group cognitive behavioural therapy | Experimental | Group CBT based on an adapted version of individual CBT for ADHD according to Safren's manual "CBT for ADHD/Mastering Your Adult ADHD". Receives: Behavioral: Group cognitive behavioural therapy (CBT) |
| Activity group | Active comparator | The Activity group is a structured manualised group intervention designed by clinicians and researchers at Sahlgrenska University Hospital. Receives: Other: 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: From enrollment to the follow-up 12 months after end of treatment
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: At enrollment and after 12 weeks at end of treatment
Secondary outcomes (4)
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: From enrollment to the follow-up 12 months after end of treatment
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: From enrollment to the follow-up 12 months after end of treatment
Colour word Interference Test (CWIT)
The cognitive task CWIT from the Delis-Kaplan Executive Function System (D-KEFS) is a version of the Stoop test aiming to measure switching and inhibition.
Measured: At enrollment and after 12 weeks at end of treatment
Trail Making Test (TMT)
The cognitive test TMT from the Delis-Kaplan Executive Function System (D-KEFS) is used to measure processing speed and cognitive flexibility.
Measured: At enrollment and after 12 weeks at end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start10 Sep 2024
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604845
- Sponsor's protocol ID
- EPM Dnr 2024-02227-01
- Other IDs
- 2023-01505, 2023
- Status last verified
- Aug 2026
- First submitted
- 17 Sep 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Most individual data will be part of patients medical records.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind Randomised Controlled Trial of Group Cognitive Behavioural Therapy (CBT) Versus Activity Group Control Condition for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06604845
- Acronym / sponsor ID
- EPM Dnr 2024-02227-01
- Keywords
- Attention Deficit Hyperactivity Disorder (ADHD), Cognitive Behavioral Therapy, Controlled Clinical Trials, Randomized, Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 20 Sep 2024 (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 and impulsivity 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 12 occasions. The partipants will:
- Fill in questionnaires before and after the group intervention, and online after 6 and 12 months
- Do cognitive testing before and after the intervention
Detailed description
Despite medical 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, the reseachers will evaluate the effects of group CBT based on Safren's manual "CBT for ADHD/Mastering Your Adult ADHD" compared to an active control group. 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 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 and 12 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.
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 Safren's CBT individually administered, 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 cognitive behavioural therapy | Experimental | Behavioral: Group cognitive behavioural therapy (CBT)Group CBT based on an adapted version of individual CBT for ADHD according to Safren's manual "CBT for ADHD/Mastering Your Adult ADHD". |
| Activity group | Active comparator | Other: Activity groupThe Activity group is a structured manualised group intervention designed by clinicians and researchers at Sahlgrenska University Hospital. |
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 (3 listed)
- Ongoing psychosis or 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 cognitive behavioural therapy (CBT)CBT based on Safren's manual "CBT for ADHD/Mastering Your Adult ADHD"20 adapted for group format. The program includes psychoeducation and cognitive restructuring and aims to improve ADHD symptoms, especially planning, organisation, attention and adaptive thinking. The CBT groups will meet at the clinic weekly for 12 weeks for 2 hours including a break in the middle. The groups are led by two clinicians. | Behavioural | Group cognitive behavioural therapy |
| Activity groupThe Activity group is a structured manualised group intervention designed for this 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 12 weeks for 2 hours including a break in the middle. The groups are led by two trainers. | Other | Activity group |
Primary outcome
Change in Adult ADHD Self-Report Scale (ASRS)
Time frame: From enrollment to the follow-up 12 months after end of treatment
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: At enrollment and after 12 weeks at end of treatment
CGI-S is a 7-point scale where the clinician rate the severity of the patients illness at the time of assessment.
4 secondary outcomes
Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)
Time frame: From enrollment to the follow-up 12 months after end of treatment
Brunnsviken Brief Quality of Life Inventory (BBQ)
Time frame: From enrollment to the follow-up 12 months after end of treatment
Colour word Interference Test (CWIT)
Time frame: At enrollment and after 12 weeks at end of treatment
Trail Making Test (TMT)
Time frame: At enrollment and after 12 weeks at end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No. Most individual data will be part of patients medical records.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group cognitive behavioural therapy (CBT) and Activity group in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Vastra Gotaland Region at 1 site 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 3 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: finished, as of the sponsor's last update on 21 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 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adult ADHD Self-Report Scale (ASRS) (time frame: From enrollment to the follow-up 12 months after end of treatment). 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 21 Sep 2026.