Atopic DermatitisNCT03051958
Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis
A study testing Internet mindfulness&exposure treatment and Treatment as usual in people with Atopic Dermatitis, run by Karolinska Institutet at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Internet mindfulness&exposure treatment and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSweden
- Study dates
- 29 Mar 2017to 28 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis: Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Atopic Dermatitis
- Being tested
- Internet mindfulness&exposure treatment, Treatment as usual
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet mindfulness&exposure treatmentBehavioural
Also called I-MET
See description under "Arm".
Treatment as usualOther
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 group | Role | What they receive |
|---|---|---|
| Internet mindfulness&exposure treatment | Experimental | 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. Receives: Behavioral: Internet mindfulness&exposure treatment |
| Treatment as usual | Active comparator | 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. Receives: Other: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Oriented Eczema Measure (POEM)
Change in POEM at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: 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 (13)
Visual analogue scale itch (VAS-itch)
Change in VAS-scratch at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: 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
Visual analogue scale scratch (VAS-scratch)
Change in VAS-scratch at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: 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
Visual analogue scale sleep (VAS-sleep)
Change in VAS-sleep at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: 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
Dermatology Quality of Life Index (DLQI)
Change in DLQI at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Beck Anxiety Inventory (BAI)
Change in BAI at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Patient Health Questionnaire-9 (PHQ-9)
Change in PHQ-9 at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Perceived stress scale (PSS)
Change in PSS at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
5-dimensions itch scale (5-D itch scale)
Change in 5-D itch scale at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Insomnia Severity Index (ISI)
Change in ISI at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Self-Rated Health (SRH-5)
Change in SRH-5 at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Brunnsviken Brief Quality of life scale (BBQ)
Change in BBQ at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
EuroQoL-5 Dimension Questionnaire (EQ-5D)
Change in EQ5D at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
The Trimbos and Institute for Medical Technology Assessment Questionnaire on Costs Associated with Psychiatric Illness (TIC-P)
Change in TIC-P at post-treatment and 6 and 12 month follow-ups compared to baseline
Measured: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start29 Mar 2017
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Hedman, Karolinska Institutet
- Investigators
- Erik Hedman, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051958
- Sponsor's protocol ID
- ICBT atopic dermatitis
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Karolinska Institutet requires that a formal assessment if the data can be made public must be conducted before publishing individual level data
Publications
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.
PubMed 34009282
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03051958
- Acronym / sponsor ID
- ICBT atopic dermatitis
- Conditions
- Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 29 Mar 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Internet mindfulness&exposure treatment | Experimental | Behavioral: Internet mindfulness&exposure treatmentA 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. |
| Treatment as usual | Active comparator | Other: Treatment as usualParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet mindfulness&exposure treatmentAlso: I-METSee description under "Arm". | Behavioural | Internet mindfulness&exposure treatment |
| Treatment as usualWritten information about standard treatment for atopic dermatitis, that is information regarding how to use moisturizers and anti-inflammatory treatment such as Topical steroids. | Other | Treatment as usual |
Primary outcome
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
13 secondary outcomes
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
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
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
Dermatology Quality of Life Index (DLQI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Beck Anxiety Inventory (BAI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Patient Health Questionnaire-9 (PHQ-9)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Perceived stress scale (PSS)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
5-dimensions itch scale (5-D itch scale)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Insomnia Severity Index (ISI)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Self-Rated Health (SRH-5)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
Brunnsviken Brief Quality of life scale (BBQ)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
EuroQoL-5 Dimension Questionnaire (EQ-5D)
Time frame: baseline, post-treatment (12 weeks), 6 month follow-up, 12 month follow-up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 34009282Hedman-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.
- Individual participant dataSharing planned: No. Karolinska Institutet requires that a formal assessment if the data can be made public must be conducted before publishing individual level data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Hedman principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet mindfulness&exposure treatment and Treatment as usual in people with Atopic Dermatitis, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03051958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.