- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07614867
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
Research problem and specific questions: ADHD is a highly common diagnosis, and in addition to symptoms of inattention, hyperactivity, and impulsivity, many adults with ADHD struggle with emotion regulation, impacting relationships and work life. A specific treatment for emotion regulation in ADHD, GEARS, was developed within Northern Stockholm Psychiatry and has been in use since 2014. 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 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.
Studieoversigt
Status
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Elinor Eskilsson Strålin, PhD
- Telefonnummer: +46731583689
- E-mail: elinor.eskilsson.stralin@ki.se
Studiesteder
-
-
-
Stockholm, Sverige, 14650
- Rekruttering
- Norra Stockholms Psykiatri
-
Kontakt:
- Elinor Eskilsson Strålin, PhD
- Telefonnummer: +46731583689
- E-mail: elinor.eskilsson.stralin@ki.se
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria: (1) being diagnosed with ADHD according to DSM criteria, (2) age 18 years or above, 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Ingen indgriben: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
DEFS-LF: Self-regulation of Emotion using the subscale from the Barkley Deficits in Executive Functioning Scale
Tidsramme: 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")
|
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
|
Difficulties in Emotion Regulation Scale (DERS)
Tidsramme: 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
|
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.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Hospital Anxiety and Depression Scale (HADS)
Tidsramme: From pretreatment to end os treatment at 25 weeks
|
Measuring anxiety and depression symptoms
|
From pretreatment to end os treatment at 25 weeks
|
|
ASRS
Tidsramme: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
Measuring ADHD symptoms, 18 items rated 0-4
|
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
|
Adult ADHD Quality of Life Scale (AAQoL)
Tidsramme: From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
Measures different aspects of everyday life functioning
|
From pre-treatment to post treatment and follow up at 6 and 12 months past treatment end.
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Psykiske lidelser
- Neuroudviklingsforstyrrelser
- Opmærksomhedsunderskud og forstyrrende adfærdsforstyrrelser
- Opførsel
- Social adfærd
- Selvkontrol
- Attention Deficit Disorder med hyperaktivitet
- Følelsesmæssig regulering
- Psykoterapi
- Adfærdsdiscipliner og aktiviteter
- Socioen -miljøbehandling
- Psykoterapi, gruppe
Andre undersøgelses-id-numre
- 2023-06542-01
- 2024-04400-02, 2026-01733-02 (Anden identifikator: Swedish Ethical Review Authority)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Attention Deficit Disorder med eller uden hyperaktivitet (ADHD)
-
University Hospital, ToursIkke rekrutterer endnuAttention Deficit Disorder With or Without Hyperactivity
-
Children's National Research InstituteRekrutteringADHD | Attention Deficit Hyperactivity Disorder | Attention-Deficit Hyperactivity Disorder | Attention Deficit Disorder | TILFØJE | ADHD Overvejende uopmærksom type | ADHD - kombineret type | ADHD, overvejende hyperaktiv - impulsiv | Attention-Deficit Disorder i ungdomsårene | Attention-Deficit Hyperactivity...Forenede Stater
-
Çağlar Charles Daniel JaicksAfsluttetADHD | Attention Deficit Hyperactivity Disorder (ADHD)Tyrkiet (Türkiye)
-
Ironshore Pharmaceuticals and Development, IncAfsluttetAttention-Deficit Hyperactivity Disorder (ADHD)Forenede Stater
-
Probi ABIkke rekrutterer endnuAttention Deficit Hyperactivity Disorder (ADHD)Kina
-
University of IcelandIkke rekrutterer endnuAttention-Deficit/Hyperactivity Disorder (ADHD)
-
Qilu Hospital of Shandong UniversityIkke rekrutterer endnuAttention Deficit Hyperactivity Disorder (ADHD)
-
Universidade do Sul de Santa CatarinaAssociação Brasileira de Cannabis MedicinalRekrutteringAttention-Deficit/Hyperactivity Disorder (ADHD)Brasilien
-
Children's Hospital Medical Center, CincinnatiPatient-Centered Outcomes Research Institute; Children's Hospital of Philadelphia og andre samarbejdspartnereIkke rekrutterer endnuAttention-Deficit/Hyperactivity Disorder (ADHD)Forenede Stater
-
Qbtech ABTilmelding efter invitationAttention Deficit Hyperactivity Disorder (ADHD) | Sund frivillig | Ingen historie med ADHDForenede Stater