Cognitive Behavior Therapy for Atopic Dermatitis

Atopic Dermatitis Clinical Trial

Official title:

Exposure-based CBT for Itching in Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302625
• Other study ID #: CBT atopic
• Status: Completed
• Phase: N/A
• First received: November 19, 2014
• Last updated: March 2, 2016
• Start date: November 2014
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Behavioral:
• Cognitive behavior therapy
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.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet and Gustavsberg primary care center	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity Scoring of Atopic Dermatitis index (SCORAD)		Change from baseline to 10 weeks follow-up and 6-month follow-up	No
Secondary	Beck Anxiety Inventory		Change from baseline to 10 weeks follow-up and 6-month follow-up	No
Secondary	Montgomery-Åsberg Depression Rating Scale-Self-rated		Change from baseline to 10 weeks follow-up and 6-month follow-up	No
Secondary	Quality of Life Inventory		Change from baseline to 10 weeks follow-up and 6-month follow-up	No
Secondary	Alcohol Disorders Identification Test		Baseline only	No
Secondary	SRH-5		Change from baseline to 10 weeks follow-up and 6-month follow-up	No
Secondary	Trimbos and Institute of Technology Cost Questionnaire for Psychiatric illness (TIC-P)		Change from baseline to 10 weeks follow-up and 6-month follow-up	No