Attention Deficit Disorder With or Without Hyperactivity (ADHD)GEARSNCT07614867
Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD
A study testing Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS) in people with Attention Deficit Disorder With or Without Hyperactivity (ADHD), run by Karolinska Institutet at 1 site in Sweden.
Trial summary
This study will evaluate if a specific treatment for emotion regulation in ADHD, GEARS, effectively reduces symptoms of emotional dysregulation. GEARS will be evaluated through a randomized controlled trial (RCT) and a qualitative interview study. This project aims to investigate two main questions: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Disorder With or Without Hyperactivity (ADHD)
- What is being tested?
- Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2026to Jun 2029
- 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
- being diagnosed with ADHD according to DSM criteria,
- age 18 years or above, and
- having identified problems with emotion regulation difficulties.
Who cannot join
- diagnosis of intellectual disability,
- diagnosis of autism
- substance abuse,
- severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority,
- difficulties allocating time to participate due to social, academic or occupational circumstances hindering engagement in treatment,
- other ongoing psychotherapy, and
- difficulties accepting the group setting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Norra Stockholms Psykiatri
Stockholm, 14650
Elinor Eskilsson Strålin, PhD, +46731583689, elinor.eskilsson.stralin@ki.se
About this study
Official title: Group-based Emotion Regulation Skills Training for Adults With ADHD: GEARS, a Quantitative and Qualitative Investigation of Treatment Effects
This study will evaluate if a specific treatment for emotion regulation in ADHD, GEARS, effectively reduces symptoms of emotional dysregulation. GEARS will be evaluated through a randomized controlled trial (RCT) and a qualitative interview study.
This project aims to investigate two main questions:
Read more
- Is GEARS an effective treatment for emotion regulation difficulties in adult ADHD patients?
- How do participants perceive the impact of completing the GEARS treatment? Study 1 investigates research question 1 through an RCT comparing GEARS to a passive control group. Data are collected using validated measures before and after treatment/waiting period, as well as at six and 12 months follow ups.
Sample size: 150 participants, ensuring sufficient statistical power to detect significant between-group differences, even with some attrition.
Study 2 examines the patients' perspectives on the treatment by interviewing 15-20 participants about their experience with GEARS. The interviews focus on GEARS' perceived impact. Interviews will be recorded, transcribed, and analyzed using thematic analysis to identify key recurring themes.
Read the detailed description
The trial will evaluate the GEARS manual. ADHD is one of the most common psychiatric diagnoses, with a growing demand for psychological treatment. Many adults seek help for impaired emotion regulation, yet evidence-based treatments are lacking. GEARS has shown promising results and addresses a critical need in psychiatric outpatient care. If proven effective in controlled studies, it could be widely implemented, enhancing functional outcomes in work and family life. Given the negative impact of emotion dysregulation, establishing evidence for this clinically developed and tested method is essential. Participants Inclusion criteria; (1) being diagnosed with ADHD according to DSM criteria, (2) age 18 years orabove, and (3) having identified problems with emotion regulation difficulties. Exclusion criteria: (1) diagnosis of intellectual disability, (2) diagnosis of autism (3) substance abuse, (4) severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority, (5) difficulties allocating time to participate due to social, academic or occupational circumstances hindering engagement in treatment, (6) other ongoing psychotherapy, and (7) difficulties accepting the group setting.
Treatment will take place within psychiatric outpatient clinics in regular care in Stockholm. Participants will be randomized to either start the intervention or to waitlist control. The GEARS is conducted in groups of around 8 participants led by two skilled therapist experienced in CBT and ADHD.
Inclusion criteria Treatment Method: GEARS is a new manual-based group treatment consisting of 14 weekly 2-hour sessions with eight participants and two group leaders. The group leaders, who are licensed psychologists or psychotherapists with CBT training and experience with this patient group, undergo training in the GEARS protocol prior to the start of treatment. The protocol is based on CBT with elements of DBT, ACT, and research on emotion theory and affect dysregulation in ADHD. The treatment is adapted to the needs of individuals with ADHD and designed to provide support so that executive difficulties do not become an obstacle to benefiting from the treatment.
In addition to the group sessions, each participant receives 30-60 minutes of coaching every other week with a group leader. The purpose is to support homework assignments, the application of treatment strategies in relation to individual challenges, and to strengthen the therapeutic process. Coaching sessions can take place on-site, via telephone, or via video.
The GEARS manual gives a clear agenda for the 14 group sessions and provides PowerPoint presentations, worksheets, and texts designed to increase understanding, acceptance, and regulation of emotions. The 14 sessions of the treatment are organized to cover the following themes:
Week 1: Introduction
Week 2: Mindfulness I + Acceptance
Week 3: Mindfulness II + The Normal Function of Emotions
Week 4: Mindfulness III + Emotional Awareness
Week 5: Primary and Secondary Emotions
Week 6: Self-reinforcement of Emotions / "Finished Behavior Analysis"
Week 7: Self-reinforcement of Emotions / "Finished Behavior Analysis"
Week 8: Impulse Control
Week 9: Emotional Control and Avoidance vs. Willingness and Acceptance
Week 10: Communication Skills
Week 11: Regulating Emotions Without Avoiding Them
Week 12: Valued Directions I + Relapse Prevention
Week 13: Valued Directions II
Week 14: Relapse Prevention / Termination
Measurements: Measures of emotion regulation and symptoms of ADHD, depression, anxiety and quality of life will be used to evaluate effects of treatment. Participants will be assessed pre, post and follow up at 6 and 12 months after treatment completion.
- Being tested
- Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)
- Keywords
- ADHD, Group Therapy, Cognitive Behavior Therapy
- 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 Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)Other
The GEARS protocol is the first CBT based group therapy protocol describing an intervention designed specifically to treat emotion regulation in ADHD.
| Study group | Role | What they receive |
|---|---|---|
| GEARS intervention group | Experimental | Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS) Receives: Other: Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS) |
| Control | No intervention | Participants will wait for treatment for six months and provide data assessed at the same time points as the intervention group. Participants will receive treatment and be assessed after their treatment is completed but not at the follow ups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barkley Deficits in Executive Functioning Scale (B-DEFS) Deficits in emotion regulation subscale (DEFS-LF) : Self-regulation of Emotion using the subscale from the
Measures emotion regulation difficulties through 13 items rated from 1 ("Never or rarely") to 4 ("Very often") range: 13-52
Measured: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Difficulties in Emotion Regulation Scale (DERS)
Measures symptoms of emotion regulation difficulties through 36 items rated in a five point scale, from 1(1= almost never) to 5, (5 = almost always) range 36-180.
Measured: Assessment at pretreatment to post treatment at 15 week and after follow up at week 25. Follow up assessments at 6 and 12 months pat treatment end.
Secondary outcomes (4)
The Hospital Anxiety and Depression Scale (HADS)
Measuring symptoms of anxiety and depression through 14 questions, rated 0-3, range 0-42.
Measured: From pretreatment to end of treatment at 25 weeks
ASRS
Measuring ADHD symptoms, 18 items rated 0 (0= never) to 4 (4= very often) range 0-72
Measured: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Adult ADHD Quality of Life Scale (AAQoL)
Measures different aspects of everyday life functioning through 21 questions, rated from 1 (not at all) to 5 (very much), range 21- 105.
Measured: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Barkley Deficits in Executive Functions Scale Short Form (BDEFS-SF)
Measures executive functions in ADHD through 20 items rated from 1 (1= never or rarely) to 4 (very often) range 20-80.
Measured: up to 6 and 12 months past treatment end.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Aug 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With or Without Hyperactivity (ADHD)Studies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Model description
- A 2-armed parallell pragmatic Randomized Conrolled Trial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elinor Eskilsson Strålin, Karolinska Institutet
- Investigators
- Elinor Eskilsson Strålin, PhD, Principal investigator, Department of Clinical Neuroscience, Karolinska Institutet (KI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614867
- Sponsor's protocol ID
- 2023-06542-01
- Other IDs
- 2024-04400-02, 2026-01733-02, 2023
- Acronym
- GEARS
- Status last verified
- Aug 2026
- First submitted
- 22 May 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Emotion Regulation Skills Training for Adults With ADHD: GEARS, a Quantitative and Qualitative Investigation of Treatment Effects
- ClinicalTrials.gov ID
- NCT07614867
- Acronym / sponsor ID
- GEARS / 2023-06542-01
- Keywords
- ADHD, Group Therapy, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 29 May 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.
This study will evaluate if a specific treatment for emotion regulation in ADHD, GEARS, effectively reduces symptoms of emotional dysregulation. GEARS will be evaluated through a randomized controlled trial (RCT) and a qualitative interview study.
This project aims to investigate two main questions:
- Is GEARS an effective treatment for emotion regulation difficulties in adult ADHD patients?
- How do participants perceive the impact of completing the GEARS treatment? Study 1 investigates research question 1 through an RCT comparing GEARS to a passive control group. Data are collected using validated measures before and after treatment/waiting period, as well as at six and 12 months follow ups.
Sample size: 150 participants, ensuring sufficient statistical power to detect significant between-group differences, even with some attrition.
Study 2 examines the patients' perspectives on the treatment by interviewing 15-20 participants about their experience with GEARS. The interviews focus on GEARS' perceived impact. Interviews will be recorded, transcribed, and analyzed using thematic analysis to identify key recurring themes.
Detailed description
The trial will evaluate the GEARS manual. ADHD is one of the most common psychiatric diagnoses, with a growing demand for psychological treatment. Many adults seek help for impaired emotion regulation, yet evidence-based treatments are lacking. GEARS has shown promising results and addresses a critical need in psychiatric outpatient care. If proven effective in controlled studies, it could be widely implemented, enhancing functional outcomes in work and family life. Given the negative impact of emotion dysregulation, establishing evidence for this clinically developed and tested method is essential. Participants Inclusion criteria; (1) being diagnosed with ADHD according to DSM criteria, (2) age 18 years orabove, and (3) having identified problems with emotion regulation difficulties. Exclusion criteria: (1) diagnosis of intellectual disability, (2) diagnosis of autism (3) substance abuse, (4) severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority, (5) difficulties allocating time to participate due to social, academic or occupational circumstances hindering engagement in treatment, (6) other ongoing psychotherapy, and (7) difficulties accepting the group setting.
Treatment will take place within psychiatric outpatient clinics in regular care in Stockholm. Participants will be randomized to either start the intervention or to waitlist control. The GEARS is conducted in groups of around 8 participants led by two skilled therapist experienced in CBT and ADHD.
Inclusion criteria Treatment Method: GEARS is a new manual-based group treatment consisting of 14 weekly 2-hour sessions with eight participants and two group leaders. The group leaders, who are licensed psychologists or psychotherapists with CBT training and experience with this patient group, undergo training in the GEARS protocol prior to the start of treatment. The protocol is based on CBT with elements of DBT, ACT, and research on emotion theory and affect dysregulation in ADHD. The treatment is adapted to the needs of individuals with ADHD and designed to provide support so that executive difficulties do not become an obstacle to benefiting from the treatment.
In addition to the group sessions, each participant receives 30-60 minutes of coaching every other week with a group leader. The purpose is to support homework assignments, the application of treatment strategies in relation to individual challenges, and to strengthen the therapeutic process. Coaching sessions can take place on-site, via telephone, or via video.
The GEARS manual gives a clear agenda for the 14 group sessions and provides PowerPoint presentations, worksheets, and texts designed to increase understanding, acceptance, and regulation of emotions. The 14 sessions of the treatment are organized to cover the following themes:
Week 1: Introduction
Week 2: Mindfulness I + Acceptance
Week 3: Mindfulness II + The Normal Function of Emotions
Week 4: Mindfulness III + Emotional Awareness
Week 5: Primary and Secondary Emotions
Week 6: Self-reinforcement of Emotions / "Finished Behavior Analysis"
Week 7: Self-reinforcement of Emotions / "Finished Behavior Analysis"
Week 8: Impulse Control
Week 9: Emotional Control and Avoidance vs. Willingness and Acceptance
Week 10: Communication Skills
Week 11: Regulating Emotions Without Avoiding Them
Week 12: Valued Directions I + Relapse Prevention
Week 13: Valued Directions II
Week 14: Relapse Prevention / Termination
Measurements: Measures of emotion regulation and symptoms of ADHD, depression, anxiety and quality of life will be used to evaluate effects of treatment. Participants will be assessed pre, post and follow up at 6 and 12 months after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 2-armed parallell pragmatic Randomized Conrolled Trial
| Arm | Type | Receives |
|---|---|---|
| GEARS intervention group | Experimental | Other: Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS) |
| Control | No intervention | –Participants will wait for treatment for six months and provide data assessed at the same time points as the intervention group. Participants will receive treatment and be assessed after their treatment is completed but not at the follow ups. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- being diagnosed with ADHD according to DSM criteria,
- age 18 years or above, and
- having identified problems with emotion regulation difficulties.
Key exclusion criteria (7 listed)
- diagnosis of intellectual disability,
- diagnosis of autism
- substance abuse,
- severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority,
- difficulties allocating time to participate due to social, academic or occupational circumstances hindering engagement in treatment,
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 Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)The GEARS protocol is the first CBT based group therapy protocol describing an intervention designed specifically to treat emotion regulation in ADHD. | Other | GEARS intervention group |
Primary outcome
Barkley Deficits in Executive Functioning Scale (B-DEFS) Deficits in emotion regulation subscale (DEFS-LF) : Self-regulation of Emotion using the subscale from the
Time frame: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Measures emotion regulation difficulties through 13 items rated from 1 ("Never or rarely") to 4 ("Very often") range: 13-52
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Assessment at pretreatment to post treatment at 15 week and after follow up at week 25. Follow up assessments at 6 and 12 months pat treatment end.
Measures symptoms of emotion regulation difficulties through 36 items rated in a five point scale, from 1(1= almost never) to 5, (5 = almost always) range 36-180.
4 secondary outcomes
The Hospital Anxiety and Depression Scale (HADS)
Time frame: From pretreatment to end of treatment at 25 weeks
ASRS
Time frame: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Adult ADHD Quality of Life Scale (AAQoL)
Time frame: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Barkley Deficits in Executive Functions Scale Short Form (BDEFS-SF)
Time frame: up to 6 and 12 months past treatment end.
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 5 Aug 2026.
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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.
Elinor Eskilsson Strålin, PhD principal investigator
Department of Clinical Neuroscience, Karolinska Institutet (KI)
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 Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS) in people with Attention Deficit Disorder With or Without Hyperactivity (ADHD), run by Karolinska Institutet 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 3 inclusion and 7 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 5 Aug 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?
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 Elinor Eskilsson Strålin, PhD (+46812349059, elinor.eskilsson.stralin@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Barkley Deficits in Executive Functioning Scale (B-DEFS) Deficits in emotion regulation subscale (DEFS-LF) : Self-regulation of Emotion using the subscale from the (time frame: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.). 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 5 Aug 2026.