Clinical Trial

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

Study acronym: GEARS
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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. 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.
Protocol Amendment History 1 change
critical Primary endpoint(s) modified 2026-06-05
Trial Details
NCT Number NCT07614867
Lead Sponsor Karolinska Institutet
Conditions Attention Deficit Disorder With or Without Hyperactivity (ADHD)
Enrollment 150 participants
Start Date 2026-08-01
Primary Completion 2029-06 (estimated)
Study Completion 2029-06 (estimated)
Updated on ClinicalTrials.gov 2026-08-05