L20
Conditions
Interventions
Group 1: A course of 5 hypnotherapy group sessions (5-10 patients) plus home self-treatment supported by audio recordings during 16 weeks
Group 2: A course of 5 sessions of diet counselling (intermitt
Sponsors
Institut für Sozialmedizin, Epidemiologie und GesundheitsökonomieCharité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: - Age between 18 and 65 years, both sexes - Confirmed diagnosis of AD - Symptoms of AD for at least 6 months - At least 3 of 4 criteria for AD after Williams - Three Item Severity Score (TIS) from 2 to 7 - Average itching of skin appearances between 40 and 80 mm on a VAS (0-100 mm) over the last 7 days prior to inclusion in study - Ability to consent - Written informed consent - Mental and physical ability to perform all three study interventions.
Exclusion criteria
Exclusion criteria: - Existence of another dermatosis - Intake of systemic, i.e. oral and/or intravenous corticosteroids in the last 3 months (local class I-III corticosteroids could be used) - Topical corticosteroids class IV - Intake of other systemic medication for the treatment of AD, in particular immunomodulators or calcineurin inhibitors. -Treatment of AD with hypnotherapy or intermittent fasting within the last 3 months before study start - Sport/ exercise of moderate to intensive intensity of at least 150 minutes per week during the last 3 months before the start of the study - Psychotherapy planned in the next 12 months - Additional other complementary therapy than the study intervention currently available or planned within the next 12 months - Planned or current use of therapies that have an assumed positive effect on symptoms of AD, such as hyposensitization. - Presence or suspicion of primary or secondary malignant tumors - Known cardiovascular diseases (including dyspnea at rest, aortic stenosis, pericarditis, myocarditis, endocarditis and severe hypertension) - Diseases or condition of the musculoskeletal system which limit the ability to do sports (i.e rheumatoid arthritis, severe arthritis, endoprostheses) - Presence of diabetes mellitus - Body mass index (BMI) not within the range 19.0 to 30.0 kg/m² - Prevalence or history of eating disorders - Presence of pregnancy or breastfeeding - The presence of a serious acute and/or chronic organic or mental illness which does not allow participation in the therapy, e.g. acute or chronic psychosis, eating disorder, post-traumatic stress disorder, childhood experiences of abuse and violence - Other mental or somatic limitations that do not allow participation in therapy - Expected lack of compliance with regard to study interventions - Drug and/or alcohol abuse - Insufficient knowledge of the German language - Participation in an intervention study in the same period of the study or in the last 6 months before the start of the study. - Existing pension scheme or planned initiation of a pension scheme (early retirement due to illness).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study aims: The primary aim of the study is to explore the effects of 1) hypnotherapy, 2) intermittent fasting and diet modification, or 3) exercise in comparison to no intervention (waiting list control) in adult patients with atopic dermatitis (AD). Secondary study aims: a) Development of the study interventions within the framework of a stakeholder involvement and b) preparation of confirmatory clinical studies on the efficacy of complementary and integrated therapies in AD (hypothesis generation, selection of intervention and control as well as potential outcome parameters, sample size calculation). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Subjectively perceived itching on the visual analogue scale (VAS, 0-100mm) - VAS total AD symptoms - Number of applications of topical corticosteroids (Class I-III) within the last 7 days - General health-related quality of life by 12-item Short Form Health Survey (SF-12) - Dermatology Life Quality Index (DLQI) - Positive and Negative Affect Schedule (PANAS) - Days of incapacity for work due to AD - Therapy safety by recording adverse events The following outcome parameters are obtained after 8 and 16 weeks: - Severity of AD by SCORing Atopic Dermatitis (SCORAD) Score, 65 66 evaluated by blinded raters - Eczema Area and Severity Index (EASI), evaluated by blinded raters In addition, the expectations regarding symptomimprovement and study intervention and the patient satisfaction are assessed by patients at baseline. | — |
Countries
Germany
Contacts
Public ContactCree Margit
Institut f. Sozialmedizin, Epidemiologie u. Gesundheitsökonomie, Charité - Universitätsmedizin Berlin
Outcome results
None listed