This quality improvement study describes the revision of an internet-delivered, self-guided psychological treatment for atopic dermatitis.
Background Atopic dermatitis (AD) is a common inflammatory skin disease characterized by dry skin, eczematous lesions, and an often severe pruritus. The disease may have a negative effect on quality of life and is also associated with symptoms of anxiety and depression. Few individuals with AD receive any form of behavioral intervention. Behavioral interventions for AD are potentially efficacious but need to be constructed so that they are safe, credible, and user-friendly. We have previously reported on a feasibility study that demonstrated that a self-management version of a digital intervention based on cognitive behavioral therapy (CBT) for AD can potentially be effective in reducing AD symptoms. The aim of this secondary report was to further examine treatment feasibility and preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. Objective This is a secondary report on intervention credibility, usability, adverse events, and preliminary effects on secondary measures of a self-management digital intervention for atopic dermatitis. Methods In total, 21 adults with AD, recruited nationwide in Sweden, were assessed by telephone, and used the digital intervention for 8 weeks. Participants were also assessed directly afterward and 3 months after the end of the intervention. There was no therapist guidance. Feasibility indicators included intervention credibility, usability, and possible adverse effects. Other measures included preliminary effects on dermatological quality of life, itching sensations, depressive symptoms, and perceived stress. Results The intervention was regarded as credible and no serious adverse events were reported. System usability was, however, found to be below the predetermined cutoff for acceptable usability. Preliminary effects at 3-month follow-up were in the moderate to large range for dermatological quality of life (Cohen d=0.89, 95% CI 0.18-1.56), itching sensations (Cohen d=0.85, 95% CI 0.15-1.52), depressive symptoms (Cohen d=0.78, 95% CI 0.1-1.45), and perceived stress (Cohen d=0.75, 95% CI 0.01-1.36). Conclusions This 8-week self-management digital CBT-based intervention was, together with telephone calls before and after, a feasible intervention for participants with AD. Preliminary effects were promising and should be explored further in a randomized controlled trial. Intervention usability was, however, rated below cutoff scores. Efforts should be made to improve written material to increase usability.
IntroductionOur aim is to investigate whether a shortened digital self-care intervention is non-inferior to, and cost-effective compared with, a comprehensive and therapist-guided cognitive behavioural therapy treatment for atopic dermatitis (AD).Methods and analysisThis is a single-blind, randomised clinical non-inferiority trial at Karolinska Institutet, a medical university in Stockholm, Sweden. We will recruit 174 adult participants with AD through self-referral. Participants will be randomised 1:1 to the two experimental conditions. Participants randomised to guided care will receive internet-delivered cognitive behavioural therapy for 12 weeks. Participants randomised to digital self-care will have access to this self-guided intervention for 12 weeks. At post-treatment (primary endpoint), non-inferiority will be tested and resource use will be compared between the two treatment groups. Cost-effectiveness will be explored at 1-year follow-up. Potential mediators will be investigated. Data will be analysed intention to treat. We define non-inferiority as a three-point difference on the primary outcome measure (Patient-oriented Eczema Measure). Recruitment started in November 2022.Ethics and disseminationThis study is approved by the Swedish ethics authority (reg. no 2021-06704-01) and is preregistered at ClinicalTrials.gov. The study will be reported according to the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results of the study will be published in peer-reviewed scientific journals and disseminated to patient organisations and media.Trial registration numberNCT05517850.
Background The 14-item Short Health Anxiety Inventory (SHAI-14) is a common measure of health anxiety but its screening properties have not been studied. The aims of this study were to evaluate the SHAI-14 as a screening instrument, identify cut-offs for clinically significant health anxiety and investigate which scores correspond to different severity levels. Method The study included 1729 psychiatric patients and 85 healthy controls. Participants completed the SHAI-14 and underwent a diagnostic interview. Cut-off scores were evaluated in three scenarios to approximate screening 1) in a psychiatric clinic, 2) in a low prevalence setting and, 3) of healthy volunteers (cut-off for remission). Receiver operating characteristics were used. Classification of severity was based on the distribution of SHAI-14 scores reported by patients with clinically significant health anxiety. Results The area under the curve (AUC) values were high in all scenarios (above 0.95). The optimal cut-off scores on the SHAI-14 were 22 in the psychiatric context, 29 in a setting with low prevalence of psychiatric disorders and 18 versus healthy controls. SHAI-14 scores of 0–27 represented no or mild health anxiety, 28–32 moderate health anxiety and 33–42 substantial health anxiety. Conclusion Brief self-report measures used as screening instruments are a simple way of gathering information about the presence of specific symptoms and thus a way to detect the likelihood of a diagnosis. The SHAI-14 shows evidence of good diagnostic utility in both clinical and non-clinical settings. However, which cut-off score is to be used, depends on the intended purpose and the setting where the cut-off is used.
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