Clinical trial NCT02302625: Cognitive Behavior Therapy for Atopic Dermatitis
Official title: Exposure-based CBT for Itching in Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Cognitive behavior therapy
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Severity Scoring of Atopic Dermatitis index (SCORAD)
timeFrame: Change from baseline to 10 weeks follow-up and 6-month follow-up
Secondary outcomes:
measure: Beck Anxiety Inventory
timeFrame: Change from baseline to 10 weeks follow-up and 6-month follow-up
measure: Montgomery-Åsberg Depression Rating Scale-Self-rated
timeFrame: Change from baseline to 10 weeks follow-up and 6-month follow-up
measure: Quality of Life Inventory
timeFrame: Change from baseline to 10 weeks follow-up and 6-month follow-up
measure: Alcohol Disorders Identification Test
timeFrame: Baseline only
measure: SRH-5
timeFrame: Change from baseline to 10 weeks follow-up and 6-month follow-up
measure: Trimbos and Institute of Technology Cost Questionnaire for Psychiatric illness (TIC-P)
timeFrame: Change from baseline to 10 weeks follow-up and 6-month follow-up
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet and Gustavsberg primary care center
Study officials:
affiliation: Karolinska Institutet
name: Erik Hedman
role: PRINCIPAL_INVESTIGATOR
References: