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

NCT07599878 | Completed DMC

• 1 other identifier: ORG-100023482
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis; Group psychotherapy; Cognitive behavioural therapy; Stress management; Feasibility study; Pilot study

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Eczema Area and Severity Index (EASI) Score at 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

  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

Secondary Outcomes (6)

• Change From Baseline in Eczema Area and Severity Index (EASI) Score at Six-Month Follow-Up

  Baseline and six-month follow-up

• Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Six-Month Follow-Up

  Baseline and six-month follow-up

• Number of Participants With Clinically Meaningful Improvement in EASI Score at Week 14

  Baseline and week 14

• Number of Participants With Clinically Meaningful Improvement in SCORAD Score at Week 14

  Baseline and week 14

• Number of Participants With Clinically Meaningful Improvement in EASI Score at Six-Month Follow-Up

  Baseline and six-month follow-up

Study Arms (3)

TAU (standard dermatological treatment)

ACTIVE COMPARATOR

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.

Drug: standard dermatological care

TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy

EXPERIMENTAL

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.

Behavioral: Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST); Drug: standard dermatological care

Stress Management and Resilience Group Therapy (SRCST)

ACTIVE COMPARATOR

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.

Behavioral: Stress Management and Resilience Group Therapy (SRCST); Drug: standard dermatological care

Interventions

Stress Management and Resilience Group Therapy (SRCST) BEHAVIORAL

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.

Stress Management and Resilience Group Therapy (SRCST)

Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy (ADCBST) BEHAVIORAL

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.

TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy

standard dermatological care DRUG

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.

Stress Management and Resilience Group Therapy (SRCST); TAU (standard dermatological treatment); TAU + Atopic Dermatitis-specific Cognitive Behavioural and Schema Mode Group Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy, Semmelweis University

Budapest, 1083, Hungary

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, M.D:, Ph.D.

Model Details: Partially randomized, three-arm pilot feasibility study with parallel group design

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 20, 2026
• Study Start: September 5, 2022
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

HU (1)