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

NCT07599878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-05-20

No results posted yet for this study

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

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

DRUG

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.

Sponsors & Collaborators

  • Semmelweis University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2023-07-10
Completion
2023-07-10

Countries

  • Hungary

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07599878 on ClinicalTrials.gov