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Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis

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ClinicalTrials.gov Identifier: NCT03051958
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE January 23, 2017
First Posted Date  ICMJE February 14, 2017
Last Update Posted Date April 7, 2020
Actual Study Start Date  ICMJE April 1, 2017
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 9, 2017)
  • Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: Post-treatment (12) ]
    Mean and standard deviations will be presented
  • Alcohol Disorders Identification Test (AUDIT) [ Time Frame: Baseline ]
    This measure is used only as a mean for gathering data regarding inclusion/exclusion criteria
  • Drug Use Disorders Identification Test (DUDIT) [ Time Frame: Baseline ]
    This measure is used only as a mean for gathering data regarding inclusion/exclusion criteria
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis
Official Title  ICMJE Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis: Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Behavioral: Internet mindfulness&exposure treatment
    See description under "Arm".
    Other Name: I-MET
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Internet mindfulness&exposure treatment
  • 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.

    Intervention: Other: Treatment as usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2020)
102
Original Estimated Enrollment  ICMJE
 (submitted: February 9, 2017)
140
Actual Study Completion Date  ICMJE June 28, 2019
Actual Primary Completion Date June 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03051958
Other Study ID Numbers  ICMJE ICBT atopic dermatitis
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Responsible Party Erik Hedman, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Erik Hedman Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP