Adjunctive Group Psychotherapy for Moderate-to-Severe Atopic Dermatitis: A Pilot Feasibility Study Comparing Two Interventions
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.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Budapest, Hungría, 1083
- Department of Psychiatry and Psychotherapy, Semmelweis University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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.
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Experimental: 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.
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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.
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.
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Comparador activo: 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.
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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.
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 14
Periodo de tiempo: Baseline and week 14
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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.
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Baseline and week 14
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Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 14
Periodo de tiempo: Baseline and week 14
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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.
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Baseline and week 14
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change From Baseline in Eczema Area and Severity Index (EASI) Score at Six-Month Follow-Up
Periodo de tiempo: 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.
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Baseline and six-month follow-up
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Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Six-Month Follow-Up
Periodo de tiempo: Baseline and six-month follow-up
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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.
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Baseline and six-month follow-up
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Number of Participants With Clinically Meaningful Improvement in EASI Score at Week 14
Periodo de tiempo: Baseline and week 14
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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.
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Baseline and week 14
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Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Week 14
Periodo de tiempo: Baseline and week 14
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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.
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Baseline and week 14
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Number of Participants With Clinically Meaningful Improvement in EASI Score at Six-Month Follow-Up
Periodo de tiempo: Baseline and six-month follow-up
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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.
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Baseline and six-month follow-up
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Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Six-Month Follow-Up
Periodo de tiempo: Baseline and six-month follow-up
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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.
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Baseline and six-month follow-up
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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Actualizaciones de registros de estudio
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Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades Genéticas Congénitas
- Enfermedades del sistema inmunológico
- Hipersensibilidad, Inmediata
- Hipersensibilidad
- Enfermedades de la piel
- Enfermedades De La Piel Genéticas
- Enfermedades De La Piel Eccematosas
- Dermatitis
- Enfermedades y anomalías congénitas, hereditarias y neonatales
- Enfermedades de la piel y del tejido conectivo
- Dermatitis Atópica
Otros números de identificación del estudio
- ORG-100023482
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- CÓDIGO_ANALÍTICO
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
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