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

17. maj 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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.
Medicin: 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.
Eksperimentel: 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.
Medicin: 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.
Adfærdsmæssigt: 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.
Aktiv komparator: 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.
Medicin: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 14
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Six-Month Follow-Up
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Semmelweis University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. september 2022

Primær færdiggørelse (Faktiske)

10. juli 2023

Studieafslutning (Faktiske)

10. juli 2023

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

17. maj 2026

Først opslået (Faktiske)

20. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ORG-100023482

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

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.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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Kliniske forsøg med Atopisk dermatitis

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