Use of a Digital Psychotherapeutic App to Reduce Symptom Burden in Dermatology Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis; Eczema; Urticaria
• Intervention / Treatment: Behavioral: Digital psychotherapeutic intervention; Behavioral: Healthy365

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 Type: Interventional
• Enrollment (Estimated): 690
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ellie Choi, MBBS; Phone Number: 65 6908 2222; Email: dermatology@nuhs.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; 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; Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.; Other Names: mobile app
Active Comparator: Control; 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 application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	baseline, week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator/physician global assessment	0 to 5 point numerical rating scale, with a higher value signalling greater severity	baseline, week 8, week 16
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.	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'	week 32
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.	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.	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	baseline, week 8, week 16
Itch	0-10 numerical rating scale, with higher scores signalling greater itch	baseline, weeks 4, 8, 12, 16, 24, 32
Sleep disturbance	0-10 numerical rating scale, with higher scores signalling greater sleep disturbance	baseline, weeks 4, 8, 12, 16, 24, 32
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	baseline, week 32
Implementability - Barriers and facilitators of use	Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability	Post 32 weeks after participant's study completion
Physician assessed body surface area affected	Range from 0% (no affected area) to 100% (complete involvement)	baseline, week 8 and 16
Chronic urticaria severity	Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6.	baseline, week 8, week 16
Skin pain	0-10 numerical rating scale, greater scores signalling greater pain	baseline, week 4, week 8, week 12, week 16, week 24, week 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.	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.	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	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.	baseline and week 16
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).	week 4, week 12, week 16, week 24, week 32
Implementability - Frequency of app usage	Frequency of using the mobile app, ranging from never to everyday	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.	week 8, week 32
Implementability - Percentage completed learning paths/ modules	Passively collected in mobile app's logs.	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.	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.	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.	week 32
Implementability - Likes and dislikes	Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.	week 32
Implementability - Suggestions and feedback	Free-text question collecting suggestions and feedback to improve the mobile app.	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.	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.	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.	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.	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.	week 4, week 8, week 12, week 16, week 24, week 32

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	0, week 8
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.	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.	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.	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.	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.	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.	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.	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.	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.	baseline, week 8, week 16, 32
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.	baseline, week 8, week 16, week 24, week 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.	baseline, week 8, week 32

Collaborators and Investigators

• Sponsor: National University Hospital, Singapore
• Collaborators: National Skin Centre, Singapore; KK Women's and Children's Hospital; National University of Singapore
• Investigators: Principal Investigator: Ellie Choi, MBBS, National University Hospital, Singapore

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Actual): November 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 23, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: eczema; mental health; digital health; psoriasis; urticaria; digital; healthservices research
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases, Papulosquamous; Skin Diseases; Skin Diseases, Vascular; Skin Diseases, Eczematous; Dermatitis; Psoriasis; Eczema; Urticaria; Psychotropic Drugs
• Other Study ID Numbers: 2022/00751

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD shared includes de-identified demographics, disease outcomes and measures.
• IPD Sharing Time Frame: IPD and supporting information will be available from the time of publication and for four years thereafter.
• IPD Sharing Access Criteria: IPD and supporting information will be available from the study team on a case-by-case basis upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No