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Adjunctive Group Psychotherapy for Moderate-to-Severe Atopic Dermatitis: A Pilot Feasibility Study Comparing Two Interventions

17. května 2026 aktualizováno: Prof. Dr. Unoka Zsolt Szabolcs, Semmelweis University

Atopic dermatitis is a chronic inflammatory skin disease characterized by eczematous skin lesions and pruritus. This partially randomized, three-arm pilot feasibility study was designed to evaluate two adjunctive group psychotherapy interventions in adults with moderate-to-severe atopic dermatitis receiving standard dermatological care.

Participants were assigned to one of three study arms: treatment as usual alone, treatment as usual plus atopic dermatitis-specific cognitive behavioural and schema mode group therapy, or treatment as usual plus stress management and resilience group therapy.

The psychotherapy interventions consisted of weekly group sessions during a 14-week intervention period. Assessments were scheduled at baseline, post-intervention at week 14, and six-month follow-up. Disease severity was assessed using the Eczema Area and Severity Index and SCORing Atopic Dermatitis.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

This was a partially randomized, three-arm pilot feasibility study conducted in adults with moderate-to-severe atopic dermatitis. The study was designed to evaluate the feasibility of delivering two adjunctive group psychotherapy interventions in addition to standard dermatological care and to collect prespecified clinical, psychological, and feasibility-related outcomes.

Participants were recruited from an outpatient dermatology service. Eligible participants were adults with atopic dermatitis and baseline disease severity consistent with moderate-to-severe disease. All participants received treatment as usual, consisting of standard dermatological care according to clinical indication.

Participants were assigned to one of three study arms: treatment as usual alone; treatment as usual plus atopic dermatitis-specific cognitive behavioural and schema mode group therapy; or treatment as usual plus stress management and resilience group therapy. Participants allocated to the two psychotherapy arms were randomized between the two active group interventions. Assignment to the treatment-as-usual-only arm was non-randomized. The study was not blinded.

Both psychotherapy interventions consisted of 14 weekly group sessions. The atopic dermatitis-specific cognitive behavioural and schema mode group therapy intervention addressed disease-related psychological and behavioural processes, including itch-related coping, scratching behaviour, emotion regulation, stigma-related experiences, and schema mode work relevant to chronic skin disease. The stress management and resilience group therapy intervention addressed stress management, emotion regulation, interpersonal functioning, coping skills, and resilience.

Assessments were scheduled at baseline, post-intervention at week 14, and six-month follow-up. Disease severity was assessed using the Eczema Area and Severity Index and SCORing Atopic Dermatitis. Additional psychological and feasibility-related measures were collected as specified in the outcome measure section of the record.

The study was conducted with written informed consent from participants and approval from the relevant ethics committee.

Typ studie

Intervenční

Zápis (Aktuální)

32

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Maďarsko
      • Budapest, Maďarsko, 1083
        • Department of Psychiatry and Psychotherapy, Semmelweis University

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Age 18 years or older
  • Clinical diagnosis of atopic dermatitis
  • Moderate-to-severe atopic dermatitis, defined as SCORing Atopic Dermatitis (SCORAD) score of 25 or higher
  • Suitability for group psychotherapy confirmed through a secondary clinical interview with two psychotherapists
  • Willingness to participate in the study and provide informed consent

Exclusion Criteria:

  • Mild atopic dermatitis, defined as SCORAD score below 25
  • Other chronic inflammatory or infectious skin disease
  • Ongoing systemic immunosuppressive or biological treatment
  • Psychotic disorder
  • Drug dependence
  • Pregnancy
  • Not suitable for group psychotherapy based on the secondary clinical interview with two psychotherapists

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Aktivní komparátor: TAU (standard dermatological treatment)
All groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines.
Lék: standard dermatological care
All groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines.
Experimentální: TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy
The ADCBST consisted of 14 weekly, 2.5-hour group sessions. Therapy content was based on a structured manual combining schema mode therapy with atopic dermatitis-specific cognitive-behavioural strategies. Sessions included psychoeducation, imagery rescripting, cognitive restructuring, behavioural experiments, and role-play exercises. Therapy was delivered by two trained psychotherapists.
Lék: standard dermatological care
All groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines.
Behaviorální: Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST)
The ADCBST consisted of 14 weekly, 2.5-hour group sessions. Therapy content was based on a structured manual combining schema mode therapy with atopic dermatitis-specific cognitive-behavioural strategies. Sessions included psychoeducation, imagery rescripting, cognitive restructuring, behavioural experiments, and role-play exercises. Therapy was delivered by two trained psychotherapists.
Aktivní komparátor: Stress Management and Resilience Group Therapy (SRCST)
The SRCST consisted of 14 weekly, 2.5-hour group sessions. The SRCST intervention followed the Hungarian-adapted Williams LifeSkills protocol. Sessions addressed emotion-focused and problem-focused coping, communication, empathy, and resilience. Delivery was based on Carl Rogers' unconditional acceptance framework and Lewin's T-group method. The 14 weekly sessions were led by a consultant psychologist and a psychology assistant.
Lék: standard dermatological care
All groups received TAU as prescribed by a consultant dermatologist. This included emollients, topical corticosteroids or calcineurin inhibitors, and antihistamines in line with European AD treatment guidelines.
Behaviorální: Stress Management and Resilience Group Therapy (SRCST)
The SRCST consisted of 14 weekly, 2.5-hour group sessions. The SRCST intervention followed the Hungarian-adapted Williams LifeSkills protocol. Sessions addressed emotion-focused and problem-focused coping, communication, empathy, and resilience. Delivery was based on Carl Rogers' unconditional acceptance framework and Lewin's T-group method. The 14 weekly sessions were led by a consultant psychologist and a psychology assistant.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 14
Časové okno: Baseline and week 14
The Eczema Area and Severity Index (EASI) is a clinician-rated measure of objective atopic dermatitis severity. It evaluates erythema, excoriation, edema/papulation, and lichenification across four anatomical regions: head and neck, trunk, upper extremities, and lower extremities. Total EASI scores range from 0 to 72, with higher scores indicating greater disease severity. The outcome measure is the change in total EASI score from baseline to post-intervention assessment at week 14. A negative change indicates improvement.
Baseline and week 14
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 14
Časové okno: Baseline and week 14
The SCORing Atopic Dermatitis (SCORAD) index is a clinician-rated and patient-informed measure of atopic dermatitis severity. It includes assessment of disease extent, intensity of skin signs, and subjective symptoms including itching and sleep disturbance. Total SCORAD scores range from 0 to 103, with higher scores indicating greater disease severity. The outcome measure is the change in total SCORAD score from baseline to post-intervention assessment at week 14. A negative change indicates improvement.
Baseline and week 14

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Six-Month Follow-Up
Časové okno: Baseline and six-month follow-up
The Eczema Area and Severity Index (EASI) is a clinician-rated measure of objective atopic dermatitis severity. Total EASI scores range from 0 to 72, with higher scores indicating greater disease severity. The outcome measure is the change in total EASI score from baseline to six-month follow-up. A negative change indicates improvement.
Baseline and six-month follow-up
Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Six-Month Follow-Up
Časové okno: Baseline and six-month follow-up
The SCORing Atopic Dermatitis (SCORAD) index includes assessment of disease extent, intensity of skin signs, and subjective symptoms including itching and sleep disturbance. Total SCORAD scores range from 0 to 103, with higher scores indicating greater disease severity. The outcome measure is the change in total SCORAD score from baseline to six-month follow-up. A negative change indicates improvement.
Baseline and six-month follow-up
Number of Participants With Clinically Meaningful Improvement in EASI Score at Week 14
Časové okno: Baseline and week 14
Clinically meaningful improvement was defined as a reduction of at least 6.6 points in total EASI score from baseline to week 14. The outcome measure is the number of participants meeting this responder criterion.
Baseline and week 14
Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Week 14
Časové okno: Baseline and week 14
Clinically meaningful improvement was defined as a reduction of at least 8.7 points in total SCORAD score from baseline to week 14. The outcome measure is the number of participants meeting this responder criterion.
Baseline and week 14
Number of Participants With Clinically Meaningful Improvement in EASI Score at Six-Month Follow-Up
Časové okno: Baseline and six-month follow-up
Clinically meaningful improvement was defined as a reduction of at least 6.6 points in total EASI score from baseline to six-month follow-up. The outcome measure is the number of participants meeting this responder criterion.
Baseline and six-month follow-up
Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Six-Month Follow-Up
Časové okno: Baseline and six-month follow-up
Clinically meaningful improvement was defined as a reduction of at least 8.7 points in total SCORAD score from baseline to six-month follow-up. The outcome measure is the number of participants meeting this responder criterion.
Baseline and six-month follow-up

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Semmelweis University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

5. září 2022

Primární dokončení (Aktuální)

10. července 2023

Dokončení studie (Aktuální)

10. července 2023

Termíny zápisu do studia

První předloženo

1. května 2026

První předloženo, které splnilo kritéria kontroly kvality

17. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

17. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • ORG-100023482

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

We plan to share de-identified individual participant data (IPD), including demographic information, SCORAD and EASI scores at baseline, post-treatment, and follow-up. No personally identifiable information will be shared. Data will be provided upon reasonable request for academic or research purposes.

Časový rámec sdílení IPD

The de-identified IPD and supporting documents will be available starting 6 months after the main results are published. Access will be granted for a period of 5 years following publication.

Kritéria přístupu pro sdílení IPD

Researchers affiliated with academic or medical institutions may request access by submitting a research proposal that outlines study aims and methodology. Requests must be reviewed and approved by the study's principal investigator. Data will be shared securely via password-protected file transfer services, after the execution of a data sharing agreement.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • MÍZA
  • ICF
  • ANALYTIC_CODE
  • CSR

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Klinické studie na standard dermatological care

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