Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional

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: 
      Atopic dermatitis (AD), characterized by chronic itching and inflammation, is highly
      prevalent and leads to suffering for the individual, increased risk of depressive symptoms
      and anxiety, and high societal costs. Several behavioral factors are likely to play a role in
      the exacerbating AD symptoms over time, not least scratching, which may lead to rupture in
      the skin barrier and an increased risk of inflammation, which in turns increases AD symptoms.
      AD is also associated with avoidance behaviors that may have negative longer-term effects.
      With this in mind, psychological treatment based on exposure may be a logical method to
      achieve improvements. A few psychological treatments have been tested for AD, but to our
      knowledge none of them have been built on recently developed methods for optimizing exposure
      treatment. In a recently conducted pilot study we showed that exposure treatment, in
      combination with mindfulness training, can be associated with improvements for persons with
      AD. One challenge regarding psychological treatment is that accessibility 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.
      Internet-based treatment can be described as a form of online bibliotherapy where the
      individual is guided by a therapist who provides feedback on homework assignments. 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 perceived stress, sleep problems, depressive
      symptoms, general anxiety, and improved self-rated health, compared to treatment as usual.

      CLARIFICATION REGARDING STUDY START DATE (remark made on March 15, 2021): This trial employed
      one informed consent which was completed before the provision of screening data for the
      purpose of assessing eligibility. The first date on which a participant provided informed
      consent and screening data was Nov 27, 2016. The first date a participant was included in the
      study, as based on the assessment of eligibility criteria in accordance with the study
      protocol, was March 29, 2017. The latter date is considered to be the study start date, in
      accordance with 81 FR 65022.
    

Intervention name(s): Internet mindfulness&exposure treatment; Treatment as usual
Intervention type(s): Behavioral; Other
Intervention description(s): See description under "Arm".; Written information about standard treatment for atopic dermatitis, that is information regarding how to use moisturizers and anti-inflammatory treatment such as Topical steroids.
Other intervention name(s): I-MET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment