Karolinska Institutet
Stockholm, 17177, Sweden
NCT Number: NCT03051958
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Stockholm, 17177, Sweden
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See description under "Arm".
Other names: I-MET
Written information about standard treatment for atopic dermatitis, that is information regarding how to use moisturizers and anti-inflammatory treatment such as Topical steroids.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Time frame: Post-treatment (12)
Mean and standard deviations will be presented
Time frame: Baseline
This measure is used only as a mean for gathering data regarding inclusion/exclusion criteria
Time frame: Baseline
This measure is used only as a mean for gathering data regarding inclusion/exclusion criteria
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
Karolinska Institutet
Other
Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis: Randomized Controlled Trial
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