NCT02302625

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

March 3, 2016

Status Verified

March 1, 2016

Enrollment Period

1.3 years

First QC Date

November 19, 2014

Last Update Submit

March 2, 2016

Conditions

Keywords

Cognitive behavior therapy

Outcome Measures

Primary Outcomes (1)

  • Severity Scoring of Atopic Dermatitis index (SCORAD)

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

Secondary Outcomes (6)

  • Beck Anxiety Inventory

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

  • Montgomery-Åsberg Depression Rating Scale-Self-rated

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

  • Quality of Life Inventory

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

  • Alcohol Disorders Identification Test

    Baseline only

  • SRH-5

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

  • +1 more secondary outcomes

Study Arms (1)

Cognitive behavior therapy

EXPERIMENTAL

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

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.

Cognitive behavior therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, 13440, Sweden

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Erik Hedman

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd, psychologist

Study Record Dates

First Submitted

November 19, 2014

First Posted

November 27, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

March 3, 2016

Record last verified: 2016-03

Locations