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

NCT07614867 | Recruiting

• 2 other identifiers: 2023-06542-012024-04400-02, 2026-01733-02
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Attention Deficit Disorder With or Without Hyperactivity (ADHD)

Keywords

ADHD; Group Therapy; Cognitive Behavior Therapy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  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)

  From pretreatment to end of treatment at 25 weeks

• ASRS

  From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.

• Adult ADHD Quality of Life Scale (AAQoL)

  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)

  up to 6 and 12 months past treatment end.

Study Arms (2)

GEARS intervention group

EXPERIMENTAL

Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)

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.

Interventions

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.

GEARS intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Norra Stockholms Psykiatri

Stockholm, 14650, Sweden

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Psychotherapy, Group

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Elinor Eskilsson Strålin, PhD

  Department of Clinical Neuroscience, Karolinska Institutet (KI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elinor Eskilsson Strålin, PhD

CONTACT

+46812349059; elinor.eskilsson.stralin@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed psychologist, licensed psychotherapist, PhD in clinical psychology, postdoctoral researcher

Model Details: A 2-armed parallell pragmatic Randomized Conrolled Trial

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: May 22, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-06

Locations

SE (1)