eczema
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Cross-sectional study: - Age 18 >= - Moderate to severe atopic dermatitis, or: - Partner of a patient with atopic dermatitis Case series study: - IFS score > 25 - Patients who receive injections (biologicals) as treatment for atopic dermatitis; or patients who are eligible for biological treatment.
Exclusion criteria
Exclusion criteria: - Insufficient understanding of Dutch language. - Severe psychiatric disorders that require treatment first, such as delusional disorder or major depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study outcome is the feasibility and acceptability of the EMDR-FF treatment, measured four weeks after the check-up session. Feasibility will be assessed by evaluating patient accessibility (evaluating any logistical or practical barriers they encounter, such as travel, scheduling, or availability of the treatment), time investment (both staff and patient), resource allocation (EMDR kit), staff training, personnel capacity, and associated costs. The treatment will be considered feasible if at least 80% of patients can access the treatment without significant barriers, the required time and resources are acceptable, and the personnel can be adequately trained within the allocated timeframe. Percentages above 75% are often considered acceptable [11]. Acceptability of the treatment will be determined through a comprehensive analysis of individual structured interviews conducted four weeks post-treatment. A topic list include a series of questions designed to gather detailed feedback on various aspects of the patient's experience. To begin, patients will be asked to describe their overall experience with the treatment, providing an opportunity to express their general feelings and impressions. They will then be encouraged to reflect on specific aspects of the treatment they found positive, as well as any elements they found less pleasant. The interviews will also explore practical aspects of the treatment by asking patients whether they found it easy to follow and, if so, why. If they experienced difficulties, they will be asked to elaborate on the challenges they encountered, such as issues with scheduling sessions or following instructions. To assess the perceived effectiveness of the treatment, patients will be asked if they believe it was successful in addressing their condition. Additionally, the interview will address the topic of side effects by inquiring whether the patient experienced any adverse effects during or after the t | — |
Secondary
| Measure | Time frame |
|---|---|
| Three secondary outcome measures are used: - The Dutch translation of the Injection Phobia Scale - Anxiety (IPS-Anx) [12], the Injectiefobie Schaal (IFS), The IFS is an 18-item self-report measure. For the purpose of this study, two additional items are included, namely: *Having an injection in your thigh* and *Having an injection in your belly*. Items are scored on a 5-point Likert scale. It measures the anxiety level with different injection and/or venepuncture procedures. Individuals rate their anxiety on a scale ranging from 0 (No anxiety) to 4 (Maximum anxiety). The IFS is measured at baseline (T0), post treatment 1 week after the check-up session (T1) and at follow-up 4 weeks after the check-up session (T2). - The SKINDEX-17, which is a dermatology-specific health-related quality of life (HRQOL) instrument [13]. It consists of 17 items to be scored on a 5-point Likert scale. The instrument has two subscales: psychosocial impact and impact of symptoms. The SKINDEX-17 is measured at baseline (T0), post treatment 1 week after the check-up session (T1) and at follow-up 4 weeks after the check-up session (T2). - The Generalised Anxiety Disorder - 7 (GAD-7) is a 7-item instrument which assesses the severity of generalised anxiety disorder [14]. Patients are asked to rate the severity of his or her symptoms over the past two weeks. Items are scored on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Other study parameters: Patients are asked if they have experienced a traumatic event in the past that may have caused the fear of injections at T0. Moreover, patients are asked at T0 whether they have refused treatment in the past because of their fear of injections. Further, the number of treatment sessions per patient (1-3) will be registered. 12. Öst, L.-G., K. Hellström, and A. Kåver, One versus five sessions of exposure in the treatment of injection phobia. Behavior therapy, 1992. 23(2): p. 263-281. 13. Nijsten, T.E. | — |
Countries
Netherlands