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Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD (GEARS)

4 augustus 2026 bijgewerkt door: Elinor Eskilsson Strålin, Karolinska Institutet

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:

  1. Is GEARS an effective treatment for emotion regulation difficulties in adult ADHD patients?
  2. 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

150

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • being diagnosed with ADHD according to DSM criteria,
  • age 18 years or above, and
  • having identified problems with emotion regulation difficulties.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: GEARS intervention group
Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)
Ander: 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.
Geen tussenkomst: Control
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Barkley Deficits in Executive Functioning Scale (B-DEFS) Deficits in emotion regulation subscale (DEFS-LF) : Self-regulation of Emotion using the subscale from the
Tijdsspanne: 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
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Difficulties in Emotion Regulation Scale (DERS)
Tijdsspanne: 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.
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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
The Hospital Anxiety and Depression Scale (HADS)
Tijdsspanne: From pretreatment to end of treatment at 25 weeks
Measuring symptoms of anxiety and depression through 14 questions, rated 0-3, range 0-42.
From pretreatment to end of treatment at 25 weeks
ASRS
Tijdsspanne: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Measuring ADHD symptoms, 18 items rated 0 (0= never) to 4 (4= very often) range 0-72
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Adult ADHD Quality of Life Scale (AAQoL)
Tijdsspanne: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
Measures different aspects of everyday life functioning through 21 questions, rated from 1 (not at all) to 5 (very much), range 21- 105.
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)
Tijdsspanne: up to 6 and 12 months past treatment end.
Measures executive functions in ADHD through 20 items rated from 1 (1= never or rarely) to 4 (very often) range 20-80.
up to 6 and 12 months past treatment end.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Karolinska Institutet

Onderzoekers

  • Hoofdonderzoeker: Elinor Eskilsson Strålin, PhD, Department of Clinical Neuroscience, Karolinska Institutet (KI)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2026

Primaire voltooiing (Geschat)

1 juni 2029

Studie voltooiing (Geschat)

1 juni 2029

Studieregistratiedata

Eerst ingediend

22 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

4 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2023-06542-01
  • 2024-04400-02, 2026-01733-02 (Andere identificatie: Swedish Ethical Review Authority)

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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