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Completed

NCT Number: NCT02302625

Cognitive Behavior Therapy for Atopic Dermatitis

Atopic dermatitis is an inflammatory skin disease characterized by itching, dry skin and recurrent inflammatory eczema. It is one of the most common skin diseases and is associated with reduced quality of life, functional impairment and sleep difficulties. The present study aims to investigate a new exposure-based cognitive behavioral psychological treatment for the disorder. The trial is a small scale open trial (n=25) with assessments at baseline, post-treatment and 6-month follow-up. The primary outcome is the SCORAD.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, 13440, Sweden

About this study

Atopic dermatitis (AD)is an inflammatory skin disease characterized by itching, dry skin and recurrent inflammatory eczema. It is one of the most common skin diseases and is associated with reduced quality of life, functional impairment and sleep difficulties. There are currently no pharmacological treatments that are effective in curing the disorder in the longer-term. Itching is one of the core symptoms in AD and it has been shown that the behavioral response to itching, scratching, has a maintaining function in AD. Reducing scratching may therefore play an important role in alleviating AD. Although behavioral aspects play a significant role in AD only a few studies have investigated the effect of psychological treatment for AD. These studies have shown promising results and the present study aim to add to the body of knowledge by testing a new form of cognitive behavioral treatment for AD. This new treatment is based on the idea that patients could benefit from training in exposure to events that could lead to increase in itching while refraining from scratching. To enable this the treatment incorporates more recently developed cognitive behavioral components such as mindfulness training.

The present study aims to investigate a new exposure-based cognitive behavioral psychological treatment for the disorder. The trial is a small scale open trial (n=25) with assessments at baseline, post-treatment and 6-month follow-up. The primary outcome is the SCORAD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of AD with at least moderate severity
  • AD for at least 6 months
  • Age 18-65
  • Ability to read and write in Swedish

Exclusion criteria

  • Serious psychiatric illness
  • Concurrent light treatment or peroral treatment for AD
  • Pregnancy
  • Other concurrent or recently finished psychological treatment for AD

Treatment and study plan

Cognitive Behavior Therapy

Behavioral

Cognitive behavior therapy based on exposure and response prevention. The treatment also incorporates mindfulness training as a means to increasing tolerance for aversive thoughts and emotions associated with AD. The treatment is delivered by a licensed psychologist and comprises 10 individual weekly sessions.

Primary outcomes

  1. Severity Scoring of Atopic Dermatitis index (SCORAD)

    Time frame: Change from baseline to 10 weeks follow-up and 6-month follow-up

Secondary outcomes

  1. Beck Anxiety Inventory

    Time frame: Change from baseline to 10 weeks follow-up and 6-month follow-up

  2. Montgomery-Åsberg Depression Rating Scale-Self-rated

    Time frame: Change from baseline to 10 weeks follow-up and 6-month follow-up

  3. Quality of Life Inventory

    Time frame: Change from baseline to 10 weeks follow-up and 6-month follow-up

  4. Alcohol Disorders Identification Test

    Time frame: Baseline only

  5. SRH-5

    Time frame: Change from baseline to 10 weeks follow-up and 6-month follow-up

  6. Trimbos and Institute of Technology Cost Questionnaire for Psychiatric illness (TIC-P)

    Time frame: Change from baseline to 10 weeks follow-up and 6-month follow-up

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Exposure-based CBT for Itching in Atopic Dermatitis

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 27, 2014
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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