An interventional study of Digital psychotherapeutic intervention and Healthy365 in Eczema, Psoriasis and Urticaria, sponsored by National University Hospital, Singapore. Recruiting at 1 site in Singapore. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by National University Hospital, Singapore · Not applicable, Interventional, and Supportive care
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.
Chronic inflammatory skin diseases, despite low mortality, significantly impair quality of life. Up to 80% of dermatological patients experience severe itch and poor sleep, and related such mental health challenges as anxiety and depression. The relationship between skin diseases and mental health highlights the challenges that doctors face in treating these conditions. Existing psychotherapeutics such as Mindfulness training, Cognitive Behavioural Therapy, and Acceptance and Commitment Therapy are widely used and effective in the treatment of mental health illness. However, there is limited evidence on the application of such interventions in dermatology and most mental health apps lack robust clinical evaluation. We report the design of a randomised controlled trial to evaluate the efficacy and implementation of a mobile app containing dermatology-specified psychotherapeutic strategies in reducing QoL burden.
503 studies on the registry are indexed under Eczema; 89 are open to participants now.
This study's planned enrollment of 690 is above the median of 91 across 401 interventional studies indexed under Eczema.
Browse Eczema studies →National University Hospital, Singapore is the lead sponsor of 454 studies on the registry; 99 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with unstable psychiatric condition, characterized by
o Hospital inpatient admission for a psychiatric condition or initiation of a psychotropic medication in the prior 3 months
Patients with unstable dermatological condition, characterized by
Any of the following within 3 months
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This fully automated and self-administered intervention will be delivered via a Health Insurance Portability and Accountability Act (HIPAA) compliant mobile app developed in collaboration with Intellect Inc., a Singapore-based mobile health company with broad reach and prior research collaborations in the Asia Pacific region. A detailed discussion focusing on the engineering of the application including the user interface, data acquisition and curation technology, security and privacy assurance is available from the authors.
Behavioral: Digital psychotherapeutic intervention
Participants in the active control group will download use the Healthy365 app, a mobile health application managed by the Singapore government's Health Promotion Board. The Healthy365 app offers a variety of useful general health-related content which are not specific to skin disease. These include personalized health tracking, participation in fitness challenges, access to nutritional guidance, and personalized lifestyle recommendations.
Behavioral: Healthy365
Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
Also known as: mobile app
Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.
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).
Time frame: baseline, week 8
Physician assessed body surface area affected
Range from 0% (no affected area) to 100% (complete involvement)
Time frame: baseline, week 8 and 16
Investigator/physician global assessment
0 to 5 point numerical rating scale, with a higher value signalling greater severity
Time frame: baseline, week 8, week 16
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.
Time frame: baseline, week 8, week 16
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.
Time frame: baseline, week 8, week 16
Chronic urticaria severity
Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6.
Time frame: baseline, week 8, week 16
Composite measure of scratching
Global severity and body surface area affected of various scratching measures e.g excoriation, lichenification, prurigo
Time frame: baseline, week 8, week 16
Itch
0-10 numerical rating scale, with higher scores signalling greater itch
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
Skin pain
0-10 numerical rating scale, greater scores signalling greater pain
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Sleep disturbance
0-10 numerical rating scale, with higher scores signalling greater sleep disturbance
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
Depression
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression 8b. The raw score range for the PROMIS Depression 8b ranges from 8 to 40 with higher scores indicating greater depressive symptoms. The raw score is then converted to a T-score using a standardized conversion table. The T scores have a mean of 50 and standard deviation (SD) of 10, a higher value signals greater depressive symptoms.
Time frame: baseline, week 8, week 16, week 24 and 32
Anxiety
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety 7a. The raw score range from 7-35 with higher scores indicating greater anxiety symptoms. The raw score is then converted to a T-score using a standardized conversion table. The T scores have a mean of 50 and standard deviation (SD) of 10, a higher value signals greater depressive symptoms.
Time frame: baseline, weeks 8, 16, 24 and 32
Number of patients requiring treatment escalation
Number of patients requiring treatment escalation, defined as any of the following \- Initiation or escalation of systemic treatments; inclusive of conventional immunosuppressants, biologics, systemic steroids
Time frame: baseline, week 8, 16 and 32
Work productivity and activity impairment
Modified Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: SHP, Version 2 (WPAI+CIQ:SHP, V 2). Assesses the impact of health problems on a person's ability to work and perform regular daily activities. Scores are multiplied by 100 to express in percentages with higher scorings indicating greater impairment and less productivity. Two additional questions assessing time spent on problems associated with skin condition and employment status, respectively.
Time frame: baseline and week 16
EQ-5D-5L
EuroQol Group EQ-5D is a measure of health state/health utility. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Time frame: baseline, week 32
Skin-specific quality of life impairment
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (large impact on quality of life).
Time frame: week 4, week 12, week 16, week 24, week 32
Implementability - App Engagement Scale
App Engagement Scale. 7 questions graded on a likert scale. Items are summed, with scores ranging from 7 to 35, with a higher score indicating greater engagement.
Time frame: week 32
Implementability - Frequency of app usage
Frequency of using the mobile app, ranging from never to everyday
Time frame: week 8, week 32
Implementability - Duration of app usage
Average duration of app use each time, ranging from less than 2 minutes to more than 40 minutes.
Time frame: week 8, week 32
Implementability - Willingness to pay
Single bounded willingness to pay, 'How much would you maximally be willing to pay/month to continue using this mobile app?' with responses ranging from 'I would not use it even if free' to 'I would pay $41 or more /month'
Time frame: week 32
Implementability - Barriers and facilitators of use
Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability
Time frame: Post 32 weeks after participant's study completion
Implementability - Percentage completed learning paths/ modules
Passively collected in mobile app's logs.
Time frame: baseline to week 32
Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app
Passive collected in mobile app's logs.
Time frame: Baseline to week 32
Implementability - Collective server statistics
Mobile app's collective server access statistics is tracked to determine which pages have the lowest and highest traffic and to analyse 'helpfulness' ratings of each module.
Time frame: baseline to week 32
Implementability - Likely frequency of app use after study
Likely frequency of app usage after the study, ranging from never to everyday.
Time frame: week 32
Implementability - Likes and dislikes
Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.
Time frame: week 32
Implementability - Suggestions and feedback
Free-text question collecting suggestions and feedback to improve the mobile app.
Time frame: week 32
Physician assessed global disease severity
Assesses patient's overall, emotional, functional, and physical severity, and physician's perception of how the patient graded overall severity. Range from 0 to 10, with higher value signalling greater severity.
Time frame: baseline, week 8, week 16
Physician assessed clinical global change
Clinician-assessed change in patient's overall status since the start of the study. Ranges from very much improved to very much worse.
Time frame: week 8, week 16
Patient's disease severity grading
A question assessing patient's overall global assessment of disease severity, ranging from 0 to 10, with higher scores indicating higher severity.
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient Global Impression of Severity
Patient reported global severity rating, ranging from none to very severe.
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient Global Impression of Change
Patient reported change in overall status from the start of the study, ranging form very much improved to very much worse.
Time frame: week 4, week 8, week 12, week 16, week 24, week 32
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.
Time frame: baseline and week 16
Itch characteristic
5D Pruritus scale ranges from 5 to 25, where 5 indicates no pruritus and 25 indicates the most severe pruritus.
Time frame: 0, week 8
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.
Time frame: baseline, week 8, week 16, week 24, week 32
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.
Time frame: baseline, week 8, week 16, 32
Revised illness perception questionnaire
Assessment of how individuals perceive their illness including cognitive and emotional representations of illness across several dimensions. Each dimension is scored separately and expressed as a percentage (0-100%), with higher scores indicating more strongly held beliefs.
Time frame: baseline, week 8, week 16, 32
Resilience
Brief Resilience Scale. The total score on the Brief Resilience Scale (BRS) ranges from 6 to 30. This scale measures an individual's ability to bounce back from stress and adversity. A higher score indicates greater resilience, while a lower score suggests lower resilience.
Time frame: baseline, week 8, week 16, 24, 32
Self Efficacy in managing emotions
PROMIS self-efficacy in managing emotions 4a. Score ranges from 4 to 20 which are standardized and expressed as a percentage from 0-100%, with higher score indicating greater self efficacy.
Time frame: baseline, week 8, 32
Mindfulness
2 questions from the Cognitive and Affective Mindfulness Scale- Revised (CAMS-R). Score ranges from 0-6 with higher score indicating more mindfulness.
Time frame: baseline, week 8, 32
Self stigmatization
Weight bias internalization scale, modified for skin conditions. The score ranges from 11 to 77. Higher scores indicate greater internalization of bias/negative perception towards self.
Time frame: baseline, week 8, week 16, 32
Social Comparison
The DermSC scale comprises 3 questions, testing the general tendency for social comparison, downward negative comparison and upward negative comparison. The scores of each question (1-5 points) are tabulated (range 3-15) with a higher score indicating a greater degree of social comparison.
Time frame: baseline, week 8, week 16, 32
Well being
World Health Organisation-Five Well-Being Index (WHO-5) ranges from 0-25 which is converted to an index score 0-100 with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Time frame: baseline, week 8, week 16, 24, 32
Adherence
Self-reported treatment adherence, represented as a percentage from 0-100% where higher scores indicate greater adherence.
Time frame: baseline, week 8, week 16, 32
Self-efficacy for managing social interactions
2 questions from PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Social Interactions. It assesses confidence in social activities and help seeking, ranging from I am not at confident to I am very confident.
Time frame: baseline, week 8, week 32
Plan to share: Yes — IPD shared includes de-identified demographics, disease outcomes and measures.
Supporting information: Study protocol, Informed consent form, Analytic code
Time frame: IPD and supporting information will be available from the time of publication and for four years thereafter.
Access criteria: IPD and supporting information will be available from the study team on a case-by-case basis upon request.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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