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Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03051958
Recruitment Status : Not yet recruiting
First Posted : February 14, 2017
Last Update Posted : February 14, 2017
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet

Brief Summary:
Atopic dermatitis (AD) is highly prevalent and leads to suffering for the individual, increased risk of depressive symptoms and anxiety, and high societal costs. A few psychological treatment have been tested for AD, but to our knowledge none of them have been built on recently developed methods for optimizing exposure treatment. In addition, access to psychological treatment is limited and there is a need for new methods that could be easily disseminated. One possible solution to this problem is to deliver psychological treatment via the Internet, which has been tested in more than 100 randomized trials with good results for other clinical disorders than AD. The aim of this study was to test the effects of Internet-delivered mindfulness and exposure treatment (I-MET) for AD in a randomized controlled trial. We hypothesized that I-MET would lead to larger reductions of AD symptoms as well as psychological symptoms compared to treatment as usual.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Behavioral: Internet mindfulness&exposure treatment Other: Treatment as usual Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis: Randomized Controlled Trial
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Internet mindfulness&exposure treatment
A 12-week treatment where the main treatment components are mindfulness, exposure and response prevention, a form of cognitive behavior therapy. The treatment entails methods to increase acceptance and non-reactivity to aversive thoughts and emotions associated with AD. The treatment is delivered via the Internet and comprises 10 modules, each with a specific theme. Throughout treatment, the patient is given structured exercises to work with on a daily basis.
Behavioral: Internet mindfulness&exposure treatment
See description under "Arm".
Other Name: I-MET

Active Comparator: Treatment as usual

Participants receive information about moisturizer and anti-inflammatory lotion treatment which is treatment as usual.

After 12 weeks, patients in this arm are crossed over to treatment.

Other: Treatment as usual
Written information about standard treatment for atopic dermatitis, that is information regarding how to use moisturizers and anti-inflammatory treatment such as Topical steroids.




Primary Outcome Measures :
  1. Patient-Oriented Eczema Measure (POEM) [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, post-treatment (12 weeks) , 6 month follow-up, 12 month follow-up ]
    Change in POEM at post-treatment and 6 and 12 month follow-ups compared to baseline


Secondary Outcome Measures :
  1. Visual analogue scale itch (VAS-itch) [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, post-treatment (12 weeks), weekly during treatment, 6 month follow-up, 12 month follow-up ]
    Change in VAS-scratch at post-treatment and 6 and 12 month follow-ups compared to baseline

  2. Visual analogue scale scratch (VAS-scratch) [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in VAS-scratch at post-treatment and 6 and 12 month follow-ups compared to baseline

  3. Visual analogue scale sleep (VAS-sleep) [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in VAS-sleep at post-treatment and 6 and 12 month follow-ups compared to baseline

  4. Dermatology Quality of Life Index (DLQI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in DLQI at post-treatment and 6 and 12 month follow-ups compared to baseline

  5. Beck Anxiety Inventory (BAI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in BAI at post-treatment and 6 and 12 month follow-ups compared to baseline

  6. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in PHQ-9 at post-treatment and 6 and 12 month follow-ups compared to baseline

  7. Perceived stress scale (PSS) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in PSS at post-treatment and 6 and 12 month follow-ups compared to baseline

  8. 5-dimensions itch scale (5-D itch scale) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in 5-D itch scale at post-treatment and 6 and 12 month follow-ups compared to baseline

  9. Insomnia Severity Index (ISI) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in ISI at post-treatment and 6 and 12 month follow-ups compared to baseline

  10. Self-Rated Health (SRH-5) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in SRH-5 at post-treatment and 6 and 12 month follow-ups compared to baseline

  11. Brunnsviken Brief Quality of life scale (BBQ) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in BBQ at post-treatment and 6 and 12 month follow-ups compared to baseline

  12. EuroQoL-5 Dimension Questionnaire (EQ-5D) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in EQ5D at post-treatment and 6 and 12 month follow-ups compared to baseline

  13. The Trimbos and Institute for Medical Technology Assessment Questionnaire on Costs Associated with Psychiatric Illness (TIC-P) [ Time Frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up ]
    Change in TIC-P at post-treatment and 6 and 12 month follow-ups compared to baseline


Other Outcome Measures:
  1. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post-treatment (12) ]
    Mean and standard deviations will be presented

  2. Alcohol Disorders Identification Test (AUDIT) [ Time Frame: Baseline ]
    This measure is used only as a mean for gathering data regarding inclusion/exclusion criteria

  3. Drug Use Disorders Identification Test (DUDIT) [ Time Frame: Baseline ]
    This measure is used only as a mean for gathering data regarding inclusion/exclusion criteria

  4. Mediators using: Pain Reactivity Scale, Psychological Inflexibility in Pain Scale, Five Facets of Mindfulness- non reactivity scale, visual analogue scales for (itch, scratching and insomnia), and use of antiinflammatory skin creme [ Time Frame: baseline, week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, post-treatment (12 weeks) ]
    Change in mediators from baseline to post-treatment (12 weeks) will be correlated with change in the primary outcome during the same time period



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfills the diagnostic criteria for atopic dermatitis in accordance with Williams criteria 1994
  • at the time of inclusion the eczema should be at least moderate according to The Patient Oriented Eczema Measure (POEM)
  • Regular access to computer and internet connection
  • If on antidepressant or regular sleep medication, the medication should be stable for at least one month prior to inclusion and the person should be willing to keep the medication stable throughout the study
  • possibility to actively carry out the treatment (not go for longer journeys, do homework)
  • good understanding of written and spoken Swedish

Exclusion Criteria:

  • severe psychiatric illness (bipolar disorder, schizophrenia or other psychotic illness, substance, alcohol abuse, severe depression, suicide risk)
  • difficulties with reading or writing
  • ongoing treatment for cancer
  • pregnancy
  • other psychological treatment that i ongoing or recently terminated
  • stronger anxiety-reducing medication such as benzodiazepines
  • treatment with antibiotics that is ongoing or has been terminated less than one month prior to inclusion
  • Psoriasis
  • UV-light treatment that is ongoing or has been terminated less than one month prior to inclusion
  • oral treatment for eczema that is ongoing or has been terminated less than two month prior to inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051958


Contacts
Contact: Erik Hedman +474844633 kire.hedman@ki.se

Locations
Sweden
Karolinska Institutet Not yet recruiting
Stockholm, Sweden, 17177
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Erik Hedman Karolinska Institutet

Responsible Party: Erik Hedman, PhD, associate professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03051958     History of Changes
Other Study ID Numbers: ICBT atopic dermatitis
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Karolinska Institutet requires that a formal assessment if the data can be made public must be conducted before publishing individual level data

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases