EczemaNCT06702293
Use of a Digital Psychotherapeutic App to Reduce Symptom Burden in Dermatology Patients
A study testing Digital psychotherapeutic intervention and Healthy365 in people with Eczema and Psoriasis, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- What is being tested?
- Digital psychotherapeutic intervention and Healthy365
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 1 siteSingapore
- Study dates
- 23 Feb 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions)
- 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
- 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
- Any of the following within 3 months
Show all 9Show fewer
- inpatient admission for a dermatological condition
- Initiation of phototherapy
- Initiation of systemic therapy (conventional immunosuppressive agent, biologics, JAK inhibitors) within the last 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 609783
Ellie Choi, 67795555, dermresearchec@nuhs.edu.sg
About this study
Official title: Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
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.
Read the detailed description
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.
- Being tested
- Digital psychotherapeutic intervention, Healthy365
- Keywords
- digital health, eczema, psoriasis, urticaria, healthservices research, digital, mental health
- Medical subject headings
- Eczema, Psoriasis, Urticaria, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital psychotherapeutic interventionBehavioural
Also called mobile app
Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
Healthy365Behavioural
Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: Digital psychotherapeutic intervention |
| Control | Active comparator | 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. Receives: Behavioral: Healthy365 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: baseline, week 8
Secondary outcomes (31)
Physician assessed body surface area affected
Range from 0% (no affected area) to 100% (complete involvement)
Measured: baseline, week 8 and 16
Investigator/physician global assessment
0 to 5 point numerical rating scale, with a higher value signalling greater severity
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline, week 8, week 16
Itch
0-10 numerical rating scale, with higher scores signalling greater itch
Measured: baseline, weeks 4, 8, 12, 16, 24, 32
Skin pain
0-10 numerical rating scale, greater scores signalling greater pain
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: week 32
Implementability - Frequency of app usage
Frequency of using the mobile app, ranging from never to everyday
Measured: 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.
Measured: 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'
Measured: week 32
Implementability - Barriers and facilitators of use
Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability
Measured: Post 32 weeks after participant's study completion
Implementability - Percentage completed learning paths/ modules
Passively collected in mobile app's logs.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 32
Implementability - Likes and dislikes
Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.
Measured: week 32
Implementability - Suggestions and feedback
Free-text question collecting suggestions and feedback to improve the mobile app.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: week 4, week 8, week 12, week 16, week 24, week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start23 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EczemaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 690 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Skin Centre, Singapore, National University of Singapore, KK Women's and Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Ellie Choi, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702293
- Sponsor's protocol ID
- 2022/00751
- Status last verified
- Oct 2025
- First submitted
- 10 Oct 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD shared includes de-identified demographics, disease outcomes and measures.
Publications
Choi E, Long V, Phan P, Shen L, Lim ZV, Koh MJ, Chua JY, Dalakoti M, Ho CS, Chandran NS, Sevdalis N, Valderas JM, Hsu KJ. Protocol for a double-blinded randomised controlled trial and process evaluation of a digital psychotherapeutic app in Singapore to improve symptom burden in patients with dermatological problems. BMJ Open. 2025 Jul 25;15(7):e098266. doi: 10.1136/bmjopen-2024-098266.
PubMed 40713034
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
- ClinicalTrials.gov ID
- NCT06702293
- Acronym / sponsor ID
- 2022/00751
- Keywords
- digital health, eczema, psoriasis, urticaria, healthservices research, digital, mental health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Skin Centre, Singapore, National University of Singapore, KK Women's and Children's Hospital
- Study start
- 23 Feb 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Digital psychotherapeutic interventionThis 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. |
| Control | Active comparator | Behavioral: Healthy365Participants 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Patients with active psychiatric symptoms (e.g. active suicidal ideation, psychosis, delusions)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital psychotherapeutic interventionAlso: mobile appMobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients. | Behavioural | Intervention Arm |
| Healthy365Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle. | Behavioural | Control |
Primary outcome
Skin-specific quality of life impairment
Time frame: baseline, week 8
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (extremely large impact on quality of life).
31 secondary outcomes
Physician assessed body surface area affected
Time frame: baseline, week 8 and 16
Investigator/physician global assessment
Time frame: baseline, week 8, week 16
Eczema severity
Time frame: baseline, week 8, week 16
Psoriasis Severity
Time frame: baseline, week 8, week 16
Chronic urticaria severity
Time frame: baseline, week 8, week 16
Composite measure of scratching
Time frame: baseline, week 8, week 16
Itch
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
Skin pain
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Sleep disturbance
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
Depression
Time frame: baseline, week 8, week 16, week 24 and 32
Anxiety
Time frame: baseline, weeks 8, 16, 24 and 32
Number of patients requiring treatment escalation
Time frame: baseline, week 8, 16 and 32
Work productivity and activity impairment
Time frame: baseline and week 16
EQ-5D-5L
Time frame: baseline, week 32
Skin-specific quality of life impairment
Time frame: week 4, week 12, week 16, week 24, week 32
Implementability - App Engagement Scale
Time frame: week 32
Implementability - Frequency of app usage
Time frame: week 8, week 32
Implementability - Duration of app usage
Time frame: week 8, week 32
Implementability - Willingness to pay
Time frame: week 32
Implementability - Barriers and facilitators of use
Time frame: Post 32 weeks after participant's study completion
Implementability - Percentage completed learning paths/ modules
Time frame: baseline to week 32
Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app
Time frame: Baseline to week 32
Implementability - Collective server statistics
Time frame: baseline to week 32
Implementability - Likely frequency of app use after study
Time frame: week 32
Implementability - Likes and dislikes
Time frame: week 32
Implementability - Suggestions and feedback
Time frame: week 32
Physician assessed global disease severity
Time frame: baseline, week 8, week 16
Physician assessed clinical global change
Time frame: week 8, week 16
Patient's disease severity grading
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient Global Impression of Severity
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient Global Impression of Change
Time frame: week 4, week 8, week 12, week 16, week 24, week 32
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Derived from this study: PubMed 40713034Choi E, Long V, Phan P, Shen L, Lim ZV, Koh MJ, Chua JY, Dalakoti M, Ho CS, Chandran NS, Sevdalis N, Valderas JM, Hsu KJ. Protocol for a double-blinded randomised controlled trial and process evaluation of a digital psychotherapeutic app in Singapore to improve symptom burden in patients with dermatological problems. BMJ Open. 2025 Jul 25;15(7):e098266. doi: 10.1136/bmjopen-2024-098266.
- Individual participant dataSharing planned: Yes. IPD shared includes de-identified demographics, disease outcomes and measures.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ellie Choi, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital psychotherapeutic intervention and Healthy365 in people with Eczema and Psoriasis, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellie Choi, MBBS (65 6908 2222, dermresearchec@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin-specific quality of life impairment (time frame: baseline, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06702293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.