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

Not Applicable

Not yet recruiting

• Conditions: Eczema; Psoriasis; Urticaria

• Registration Number: NCT06702293
• Lead Sponsor: National University Hospital, Singapore

Brief 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. 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 Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Study Start: 2025-07-01
• Primary Completion: 2028-07
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 690

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Skin-specific quality of life impairment	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 Outcome Measures

Name	Time	Method
Skin-specific quality of life impairment	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).
Physician assessed body surface area affected	baseline, week 8 and 16	Range from 0% (no affected area) to 100% (complete involvement)
Investigator/physician global assessment	baseline, week 8, week 16	0 to 5 point numerical rating scale, with a higher value signalling greater severity
Eczema severity	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.
Psoriasis Severity	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.
Chronic urticaria severity	baseline, week 8, week 16	Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6.
Composite measure of scratching	baseline, week 8, week 16	Global severity and body surface area affected of various scratching measures e.g excoriation, lichenification, prurigo
Itch	baseline, weeks 4, 8, 12, 16, 24, 32	0-10 numerical rating scale, with higher scores signalling greater itch
Skin pain	baseline, week 4, week 8, week 12, week 16, week 24, week 32	0-10 numerical rating scale, greater scores signalling greater pain
Sleep disturbance	baseline, weeks 4, 8, 12, 16, 24, 32	0-10 numerical rating scale, with higher scores signalling greater sleep disturbance
Depression	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.
Anxiety	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.
Number of patients requiring treatment escalation	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
Work productivity and activity impairment	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.
EQ-5D-5L	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
Implementability - App Engagement Scale	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.
Implementability - Frequency of app usage	week 8, week 32	Frequency of using the mobile app, ranging from never to everyday
Implementability - Duration of app usage	week 8, week 32	Average duration of app use each time, ranging from less than 2 minutes to more than 40 minutes.
Implementability - Willingness to pay	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'
Implementability - Barriers and facilitators of use	Post 32 weeks after participant's study completion	Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability
Implementability - Percentage completed learning paths/ modules	baseline to week 32	Passively collected in mobile app's logs.
Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app	Baseline to week 32	Passive collected in mobile app's logs.
Implementability - Collective server statistics	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.
Implementability - Likely frequency of app use after study	week 32	Likely frequency of app usage after the study, ranging from never to everyday.
Implementability - Likes and dislikes	week 32	Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.
Implementability - Suggestions and feedback	week 32	Free-text question collecting suggestions and feedback to improve the mobile app.
Physician assessed global disease severity	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.
Physician assessed clinical global change	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.
Patient's disease severity grading	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.
Patient Global Impression of Severity	baseline, week 4, week 8, week 12, week 16, week 24, week 32	Patient reported global severity rating, ranging from none to very severe.
Patient Global Impression of Change	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.