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

National University Health System (NUHS)

Status: Begins enrollment in 4 months

Conditions: Psoriasis; Urticaria; Eczema

Treatments: Behavioral: Healthy365; Behavioral: Digital psychotherapeutic intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06702293

2022/00751

Details and patient eligibility

About

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.

Full 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.

Enrollment: 690 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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690 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Digital psychotherapeutic intervention

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: Healthy365