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

Recruiting · NCT07614867 · Interventional (participants receive a specific treatment) · Lead sponsor: Karolinska Institutet

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ADHD

Interventions studied

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

What this trial is about

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 take part

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

1 location listed.

Norra Stockholms Psykiatri - Stockholm, Sweden

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →