Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
being diagnosed with ADHD according to DSM criteria,
age 18 years or above, and
having identified problems with emotion regulation difficulties.
Disqualifiers
diagnosis of intellectual disability,
diagnosis of autism
substance abuse,
severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority,
Trial design
Design model
Parallel
Treatments tested in this trial
Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)
Other interventionThe GEARS protocol is the first CBT based group therapy protocol describing an intervention designed specifically to treat emotion regulation in ADHD.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: GEARS intervention groupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
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
Measures emotion regulation difficulties through 13 items rated from 1 ("Never or rarely") to 4 ("Very often") range: 13-52
Time frame
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.2
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.
Time frame
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
1
The Hospital Anxiety and Depression Scale (HADS)
Measuring symptoms of anxiety and depression through 14 questions, rated 0-3, range 0-42.
Time frame
From pretreatment to end of treatment at 25 weeks2
ASRS
Measuring ADHD symptoms, 18 items rated 0 (0= never) to 4 (4= very often) range 0-72
Time frame
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.3
Adult ADHD Quality of Life Scale (AAQoL)
Measures different aspects of everyday life functioning through 21 questions, rated from 1 (not at all) to 5 (very much), range 21- 105.
Time frame
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.4
Barkley Deficits in Executive Functions Scale Short Form (BDEFS-SF)
Measures executive functions in ADHD through 20 items rated from 1 (1= never or rarely) to 4 (very often) range 20-80.
Time frame
up to 6 and 12 months past treatment end.Sponsors and contacts
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Source ClinicalTrials.gov