About this trial
Skin diseases, despite low mortality, significantly impair quality of life. This randomised controlled trial evaluates the efficacy of a digital toolkit comprising psychotherapeutic strategies in reducing QoL burden in patients with chronic inflammatory skin conditions. This toolkit is hosted on a mobile application and will be used by study participants randomised to the intervention arm over the 32 week study period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with psoriasis, eczema or chronic urticaria diagnosed by a dermatologist
Aged 16 or older
Peak pruritus intensity of 4 or more on a 11-point numerical rating scale (0-10, with 10 representing worst itch)
Able to engage with a mobile application in the English language
Disqualifiers
Patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions)
Patients with unstable psychiatric condition, characterized by
Patients with unstable dermatological condition, characterized by
Recent flare of the skin condition within the last 2 weeks, including diagnosis of a flare by a doctor, use of systemic steroids, oral antibiotics, wet wrap rescue therapy, oral antivirals, or increase in frequency of phototherapy or dose of systemic medications for the dermatological condition within the last 2 weeks OR
Trial design
Parallel
Treatments tested in this trial
Digital psychotherapeutic intervention
BehavioralMobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
Healthy365
BehavioralMobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.
Treatment groups
Trial outcomes
Primary outcomes
Skin-specific quality of life impairment
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (extremely large impact on quality of life).
Secondary outcomes
Physician assessed body surface area affected
Range from 0% (no affected area) to 100% (complete involvement)
Investigator/physician global assessment
0 to 5 point numerical rating scale, with a higher value signalling greater severity
Eczema severity
Eczema Area and Severity Index. Scoring system used to assess the severity of atopic dermatitis. Score ranges from 0 to 72 with higher score indicating worse severity.
Psoriasis Severity
Psoriasis Area and Severity Index. Severity assessment for patients with psoriasis. Score ranges from 0-72 with higher scoring indicating more severe disease.
Other outcomes
Type D personality
DS-14, measure of type D personality. The negative affect and social inhibition scales are scored from 0-28 with a higher score representing greater trait. A cutoff of 10 on each scale is used to classify type D personality.
Itch characteristic
5D Pruritus scale ranges from 5 to 25, where 5 indicates no pruritus and 25 indicates the most severe pruritus.
Scratching behavior
PROMIS Itch Questionnaire Scratching Behaviour 5a. Score ranges fro 0-25 with higher score indicating greater scratching behaviours. Scores are standardized with 50 representing the mean.
Acceptance of health condition
Acceptance of Chronic Health Conditions Scale. Scores range from 8 to 40. Higher scores indicate greater acceptance of the chronic health condition.
Sponsors and contacts
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National University Hospital, Singapore
Lead sponsor
National Skin Centre, Singapore
Collaborator
National University of Singapore
Collaborator
KK Women's and Children's Hospital
Collaborator