Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD (NCT07614867) | Clinical Trial Compass
RecruitingNot Applicable
Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD
Sweden150 participantsStarted 2026-05-22
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing group-based CBT specifically focused on emotion regulation in adults with ADHD — how does my own pattern of emotional difficulties with ADHD compare to what this study is targeting, and does that make it a good or poor fit for me?
2Since this study is Phase NA, which typically means it's evaluating a behavioral or psychological intervention rather than a drug, what does my doctor think about the current evidence base for CBT targeting emotion regulation in adult ADHD, and how does this trial's approach compare to what's already available to me?
3The trial is measuring changes using tools like the DERS and the Barkley Deficits in Executive Functioning Scale — can my doctor explain what those scales are actually measuring, and would I be able to track whether my own symptoms are improving in a meaningful way during the study?
4Because this is a group-based therapy format, how might the group setting affect my experience compared to individual therapy, and are there reasons my doctor thinks one format might suit me better than the other given my specific situation?
5If I were to join this trial, would it be compatible with any medication or other treatment I'm currently using for ADHD, or would I need to pause or change anything in my existing care plan??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Barkley Deficits in Executive Functioning Scale (B-DEFS) Deficits in emotion regulation subscale (DEFS-LF) : Self-regulation of Emotion using the subscale from the
Timeframe: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
2
Difficulties in Emotion Regulation Scale (DERS)
Timeframe: 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.