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

NCT06702293 | Not Yet Recruiting

• 1 other identifier: 2022/00751
• Study Type: interventional
• Target: 690
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eczema; Psoriasis; Urticaria

Keywords

digital health; eczema; psoriasis; urticaria; healthservices research; digital; mental health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (31)

• Physician assessed body surface area affected

  baseline, week 8 and 16

• Investigator/physician global assessment

  baseline, week 8, week 16

• Eczema severity

  baseline, week 8, week 16

• Psoriasis Severity

  baseline, week 8, week 16

• Chronic urticaria severity

  baseline, week 8, week 16

Other Outcomes (13)

• Type D personality

  baseline and week 16

• Itch characteristic

  0, week 8

• Scratching behavior

  baseline, week 8, week 16, week 24, week 32

Study Arms (2)

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.

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.

Behavioral: Healthy365

Interventions

Digital psychotherapeutic intervention BEHAVIORAL

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

Also known as: mobile app

Intervention Arm

Healthy365 BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• 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.

  PMID: 40713034 DERIVED

MeSH Terms

Conditions

Eczema; Psoriasis; Urticaria; Psychological Well-Being

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous; Skin Diseases, Vascular; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Personal Satisfaction; Behavior

Study Officials

• Ellie Choi, MBBS

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellie Choi, MBBS

CONTACT

65 6908 2222; dermatology@nuhs.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: November 22, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 26, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, 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.