Evaluating Effects of Group-based CBT for Emotion Regulation in Adult ADHD (GEARS)
Group-based Emotion Regulation Skills Training for Adults With ADHD: GEARS, a Quantitative and Qualitative Investigation of Treatment Effects
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:
- Is GEARS an effective treatment for emotion regulation difficulties in adult ADHD patients?
- 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.
Studieöversikt
Status
Detaljerad beskrivning
The trial will evaluate the GEARS manual. ADHD is one of the most common psychiatric diagnoses, with a growing demand for psychological treatment. Many adults seek help for impaired emotion regulation, yet evidence-based treatments are lacking. GEARS has shown promising results and addresses a critical need in psychiatric outpatient care. If proven effective in controlled studies, it could be widely implemented, enhancing functional outcomes in work and family life. Given the negative impact of emotion dysregulation, establishing evidence for this clinically developed and tested method is essential. Participants Inclusion criteria; (1) being diagnosed with ADHD according to DSM criteria, (2) age 18 years orabove, and (3) having identified problems with emotion regulation difficulties. Exclusion criteria: (1) diagnosis of intellectual disability, (2) diagnosis of autism (3) substance abuse, (4) severe mental illness (e.g., severe depression, anorexia) or comorbidity requiring clinical priority, (5) difficulties allocating time to participate due to social, academic or occupational circumstances hindering engagement in treatment, (6) other ongoing psychotherapy, and (7) difficulties accepting the group setting.
Treatment will take place within psychiatric outpatient clinics in regular care in Stockholm. Participants will be randomized to either start the intervention or to waitlist control. The GEARS is conducted in groups of around 8 participants led by two skilled therapist experienced in CBT and ADHD.
Inclusion criteria Treatment Method: GEARS is a new manual-based group treatment consisting of 14 weekly 2-hour sessions with eight participants and two group leaders. The group leaders, who are licensed psychologists or psychotherapists with CBT training and experience with this patient group, undergo training in the GEARS protocol prior to the start of treatment. The protocol is based on CBT with elements of DBT, ACT, and research on emotion theory and affect dysregulation in ADHD. The treatment is adapted to the needs of individuals with ADHD and designed to provide support so that executive difficulties do not become an obstacle to benefiting from the treatment.
In addition to the group sessions, each participant receives 30-60 minutes of coaching every other week with a group leader. The purpose is to support homework assignments, the application of treatment strategies in relation to individual challenges, and to strengthen the therapeutic process. Coaching sessions can take place on-site, via telephone, or via video.
The GEARS manual gives a clear agenda for the 14 group sessions and provides PowerPoint presentations, worksheets, and texts designed to increase understanding, acceptance, and regulation of emotions. The 14 sessions of the treatment are organized to cover the following themes:
Week 1: Introduction
Week 2: Mindfulness I + Acceptance
Week 3: Mindfulness II + The Normal Function of Emotions
Week 4: Mindfulness III + Emotional Awareness
Week 5: Primary and Secondary Emotions
Week 6: Self-reinforcement of Emotions / "Finished Behavior Analysis"
Week 7: Self-reinforcement of Emotions / "Finished Behavior Analysis"
Week 8: Impulse Control
Week 9: Emotional Control and Avoidance vs. Willingness and Acceptance
Week 10: Communication Skills
Week 11: Regulating Emotions Without Avoiding Them
Week 12: Valued Directions I + Relapse Prevention
Week 13: Valued Directions II
Week 14: Relapse Prevention / Termination
Measurements: Measures of emotion regulation and symptoms of ADHD, depression, anxiety and quality of life will be used to evaluate effects of treatment. Participants will be assessed pre, post and follow up at 6 and 12 months after treatment completion.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Elinor Eskilsson Strålin, PhD
- Telefonnummer: +46812349059
- E-post: elinor.eskilsson.stralin@ki.se
Studieorter
-
-
-
Stockholm, Sverige, 14650
- Rekrytering
- Norra Stockholms Psykiatri
-
Kontakt:
- Elinor Eskilsson Strålin, PhD
- Telefonnummer: +46731583689
- E-post: elinor.eskilsson.stralin@ki.se
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: GEARS intervention group
Group Therapy for Improving Emotional Acceptance and Regulatory Skills in Adults with ADHD (GEARS)
|
The GEARS protocol is the first CBT based group therapy protocol describing an intervention designed specifically to treat emotion regulation in ADHD.
|
|
Inget ingripande: Control
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Barkley Deficits in Executive Functioning Scale (B-DEFS) Deficits in emotion regulation subscale (DEFS-LF) : Self-regulation of Emotion using the subscale from the
Tidsram: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
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)
Tidsram: 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.
|
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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Hospital Anxiety and Depression Scale (HADS)
Tidsram: From pretreatment to end of treatment at 25 weeks
|
Measuring symptoms of anxiety and depression through 14 questions, rated 0-3, range 0-42.
|
From pretreatment to end of treatment at 25 weeks
|
|
ASRS
Tidsram: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
Measuring ADHD symptoms, 18 items rated 0 (0= never) to 4 (4= very often) range 0-72
|
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
|
Adult ADHD Quality of Life Scale (AAQoL)
Tidsram: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
Measures different aspects of everyday life functioning through 21 questions, rated from 1 (not at all) to 5 (very much), range 21- 105.
|
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)
Tidsram: up to 6 and 12 months past treatment end.
|
Measures executive functions in ADHD through 20 items rated from 1 (1= never or rarely) to 4 (very often) range 20-80.
|
up to 6 and 12 months past treatment end.
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Elinor Eskilsson Strålin, PhD, Department of Clinical Neuroscience, Karolinska Institutet (KI)
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2023-06542-01
- 2024-04400-02, 2026-01733-02 (Annan identifierare: Swedish Ethical Review Authority)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .