Clinical trial NCT03051958: Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis
Official title: Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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.

Eligibility 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

Primary outcomes:
measure: Patient-Oriented Eczema Measure (POEM)
timeFrame: 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
Secondary outcomes:
measure: Visual analogue scale itch (VAS-itch)
timeFrame: 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
measure: Visual analogue scale scratch (VAS-scratch)
timeFrame: 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
measure: Visual analogue scale sleep (VAS-sleep)
timeFrame: 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
measure: Dermatology Quality of Life Index (DLQI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Perceived stress scale (PSS)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: 5-dimensions itch scale (5-D itch scale)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Insomnia Severity Index (ISI)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Self-Rated Health (SRH-5)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: Brunnsviken Brief Quality of life scale (BBQ)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: EuroQoL-5 Dimension Questionnaire (EQ-5D)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
measure: The Trimbos and Institute for Medical Technology Assessment Questionnaire on Costs Associated with Psychiatric Illness (TIC-P)
timeFrame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Other outcomes:
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: Post-treatment (12)
measure: Alcohol Disorders Identification Test (AUDIT)
timeFrame: Baseline
measure: Drug Use Disorders Identification Test (DUDIT)
timeFrame: Baseline
measure: 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
timeFrame: 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)
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Institutet
name: Erik Hedman
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedman-Lagerlof E, Fust J, Axelsson E, Bonnert M, Lalouni M, Molander O, Agrell P, Bergman A, Lindefors N, Bradley M. Internet-Delivered Cognitive Behavior Therapy for Atopic Dermatitis: A Randomized Clinical Trial. JAMA Dermatol. 2021 Jul 1;157(7):796-804. doi: 10.1001/jamadermatol.2021.1450.