CClinicalTrials.gg
CompletedNCT02302625Updated Mar 3, 2016

Cognitive Behavior Therapy for Atopic Dermatitis

An interventional study of Cognitive behavior therapy in Atopic Dermatitis, sponsored by Karolinska Institutet. Completed at 1 site in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-03.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
9
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Cognitive behavior therapy
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 9 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Serious psychiatric illness
  • Concurrent light treatment or peroral treatment for AD
  • Pregnancy
  • Other concurrent or recently finished psychological treatment for AD
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
9 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: Cognitive behavior therapy

Interventions

  • BehavioralCognitive 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.

06

What researchers measure

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

07

Study locations

1 site
  • Karolinska Institutet and Gustavsberg primary care center
    Stockholm, 13440, Sweden
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02302625
Lead sponsor
Karolinska Institutet
Responsible party
Erik Hedman (Phd, psychologist, Karolinska Institutet) — Principal investigator
First posted
Nov 27, 2014
Start date
Nov 2014
Primary completion
Feb 2016
Completion
Feb 2016
Last update
Mar 3, 2016

Study contacts

Erik Hedman
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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