Cognitive Behavior Therapy for Atopic Dermatitis
Primary Purpose
Atopic Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cognitive behavior therapy
Sponsored by
About this trial
This is an interventional treatment trial for Atopic Dermatitis focused on measuring Cognitive behavior therapy
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
Sites / Locations
- Karolinska Institutet and Gustavsberg primary care center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Cognitive behavior therapy
Arm Description
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.
Outcomes
Primary Outcome Measures
Severity Scoring of Atopic Dermatitis index (SCORAD)
Secondary Outcome Measures
Beck Anxiety Inventory
Montgomery-Åsberg Depression Rating Scale-Self-rated
Quality of Life Inventory
Alcohol Disorders Identification Test
SRH-5
Trimbos and Institute of Technology Cost Questionnaire for Psychiatric illness (TIC-P)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02302625
Brief Title
Cognitive Behavior Therapy for Atopic Dermatitis
Official Title
Exposure-based CBT for Itching in Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Cognitive behavior therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive behavior therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive behavior therapy
Intervention Description
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 Outcome Measure Information:
Title
Severity Scoring of Atopic Dermatitis index (SCORAD)
Time Frame
Change from baseline to 10 weeks follow-up and 6-month follow-up
Secondary Outcome Measure Information:
Title
Beck Anxiety Inventory
Time Frame
Change from baseline to 10 weeks follow-up and 6-month follow-up
Title
Montgomery-Åsberg Depression Rating Scale-Self-rated
Time Frame
Change from baseline to 10 weeks follow-up and 6-month follow-up
Title
Quality of Life Inventory
Time Frame
Change from baseline to 10 weeks follow-up and 6-month follow-up
Title
Alcohol Disorders Identification Test
Time Frame
Baseline only
Title
SRH-5
Time Frame
Change from baseline to 10 weeks follow-up and 6-month follow-up
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Hedman
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet and Gustavsberg primary care center
City
Stockholm
ZIP/Postal Code
13440
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Cognitive Behavior Therapy for Atopic Dermatitis
We'll reach out to this number within 24 hrs