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NCT Number: NCT06702293

Use of a Digital Psychotherapeutic App to Reduce 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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Hospital

Singapore, 609783

Location status: Recruiting

Location contact

Ellie Choi

CONTACT

[email protected]

67795555

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • inpatient admission for a dermatological condition
  • Initiation of phototherapy
  • Initiation of systemic therapy (conventional immunosuppressive agent, biologics, JAK inhibitors) within the last 3 months.

Treatment and study plan

Digital psychotherapeutic intervention

Behavioral

Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.

Other names: mobile app

Healthy365

Behavioral

Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Physician assessed body surface area affected

    Time frame: baseline, week 8 and 16

    Range from 0% (no affected area) to 100% (complete involvement)

  2. Investigator/physician global assessment

    Time frame: baseline, week 8, week 16

    0 to 5 point numerical rating scale, with a higher value signalling greater severity

  3. Eczema severity

    Time frame: baseline, week 8, week 16

    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.

  4. Psoriasis Severity

    Time frame: baseline, week 8, week 16

    Psoriasis Area and Severity Index. Severity assessment for patients with psoriasis. Score ranges from 0-72 with higher scoring indicating more severe disease.

  5. Chronic urticaria severity

    Time frame: baseline, week 8, week 16

    Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6.

  6. Composite measure of scratching

    Time frame: baseline, week 8, week 16

    Global severity and body surface area affected of various scratching measures e.g excoriation, lichenification, prurigo

  7. Itch

    Time frame: baseline, weeks 4, 8, 12, 16, 24, 32

    0-10 numerical rating scale, with higher scores signalling greater itch

  8. Skin pain

    Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32

    0-10 numerical rating scale, greater scores signalling greater pain

  9. Sleep disturbance

    Time frame: baseline, weeks 4, 8, 12, 16, 24, 32

    0-10 numerical rating scale, with higher scores signalling greater sleep disturbance

  10. Depression

    Time frame: baseline, week 8, week 16, week 24 and 32

    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.

  11. Anxiety

    Time frame: baseline, weeks 8, 16, 24 and 32

    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.

  12. Number of patients requiring treatment escalation

    Time frame: baseline, week 8, 16 and 32

    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
  13. Work productivity and activity impairment

    Time frame: baseline and week 16

    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.

  14. EQ-5D-5L

    Time frame: baseline, week 32

    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

  15. Skin-specific quality of life impairment

    Time frame: week 4, week 12, week 16, week 24, week 32

    Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (large impact on quality of life).

  16. Implementability - App Engagement Scale

    Time frame: week 32

    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.

  17. Implementability - Frequency of app usage

    Time frame: week 8, week 32

    Frequency of using the mobile app, ranging from never to everyday

  18. Implementability - Duration of app usage

    Time frame: week 8, week 32

    Average duration of app use each time, ranging from less than 2 minutes to more than 40 minutes.

  19. Implementability - Willingness to pay

    Time frame: week 32

    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'

  20. Implementability - Barriers and facilitators of use

    Time frame: Post 32 weeks after participant's study completion

    Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability

  21. Implementability - Percentage completed learning paths/ modules

    Time frame: baseline to week 32

    Passively collected in mobile app's logs.

  22. Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app

    Time frame: Baseline to week 32

    Passive collected in mobile app's logs.

  23. Implementability - Collective server statistics

    Time frame: baseline to week 32

    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.

  24. Implementability - Likely frequency of app use after study

    Time frame: week 32

    Likely frequency of app usage after the study, ranging from never to everyday.

  25. Implementability - Likes and dislikes

    Time frame: week 32

    Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.

  26. Implementability - Suggestions and feedback

    Time frame: week 32

    Free-text question collecting suggestions and feedback to improve the mobile app.

  27. Physician assessed global disease severity

    Time frame: baseline, week 8, week 16

    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.

  28. Physician assessed clinical global change

    Time frame: week 8, week 16

    Clinician-assessed change in patient's overall status since the start of the study. Ranges from very much improved to very much worse.

  29. Patient's disease severity grading

    Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32

    A question assessing patient's overall global assessment of disease severity, ranging from 0 to 10, with higher scores indicating higher severity.

  30. Patient Global Impression of Severity

    Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32

    Patient reported global severity rating, ranging from none to very severe.

  31. Patient Global Impression of Change

    Time frame: week 4, week 8, week 12, week 16, week 24, week 32

    Patient reported change in overall status from the start of the study, ranging form very much improved to very much worse.

Other outcomes

  1. Type D personality

    Time frame: baseline and week 16

    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.

  2. Itch characteristic

    Time frame: 0, week 8

    5D Pruritus scale ranges from 5 to 25, where 5 indicates no pruritus and 25 indicates the most severe pruritus.

  3. Scratching behavior

    Time frame: baseline, week 8, week 16, week 24, week 32

    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.

  4. Acceptance of health condition

    Time frame: baseline, week 8, week 16, 32

    Acceptance of Chronic Health Conditions Scale. Scores range from 8 to 40. Higher scores indicate greater acceptance of the chronic health condition.

  5. Revised illness perception questionnaire

    Time frame: baseline, week 8, week 16, 32

    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.

  6. Resilience

    Time frame: baseline, week 8, week 16, 24, 32

    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.

  7. Self Efficacy in managing emotions

    Time frame: baseline, week 8, 32

    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.

  8. Mindfulness

    Time frame: baseline, week 8, 32

    2 questions from the Cognitive and Affective Mindfulness Scale- Revised (CAMS-R). Score ranges from 0-6 with higher score indicating more mindfulness.

  9. Self stigmatization

    Time frame: baseline, week 8, week 16, 32

    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.

  10. Social Comparison

    Time frame: baseline, week 8, week 16, 32

    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.

  11. Well being

    Time frame: baseline, week 8, week 16, 24, 32

    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.

  12. Adherence

    Time frame: baseline, week 8, week 16, 32

    Self-reported treatment adherence, represented as a percentage from 0-100% where higher scores indicate greater adherence.

  13. Self-efficacy for managing social interactions

    Time frame: baseline, week 8, week 32

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellie Choi, MBBS

CONTACT

[email protected]

65 6908 2222

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • KK Women's and Children's Hospital
  • National Skin Centre, Singapore
  • National University of Singapore

Registry information

Official study title

Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Nov 22, 2024
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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