Clinical trial NCT06702293: Use of a Digital Psychotherapeutic App to Reduce Symptom Burden in Dermatology Patients
Official title: Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Eczema
Psoriasis
Urticaria
Keywords: digital health
eczema
psoriasis
urticaria
healthservices research
digital
mental health
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Skin Centre, Singapore
name: National University of Singapore
name: KK Women's and Children's Hospital
First posted: 2024-11-22
Enrollment: 690
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Skin-specific quality of life impairment
timeFrame: baseline, week 8
Secondary outcomes:
measure: Physician assessed body surface area affected
timeFrame: baseline, week 8 and 16
measure: Investigator/physician global assessment
timeFrame: baseline, week 8, week 16
measure: Eczema severity
timeFrame: baseline, week 8, week 16
measure: Psoriasis Severity
timeFrame: baseline, week 8, week 16
measure: Chronic urticaria severity
timeFrame: baseline, week 8, week 16
measure: Composite measure of scratching
timeFrame: baseline, week 8, week 16
measure: Itch
timeFrame: baseline, weeks 4, 8, 12, 16, 24, 32
measure: Skin pain
timeFrame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
measure: Sleep disturbance
timeFrame: baseline, weeks 4, 8, 12, 16, 24, 32
measure: Depression
timeFrame: baseline, week 8, week 16, week 24 and 32
measure: Anxiety
timeFrame: baseline, weeks 8, 16, 24 and 32
measure: Number of patients requiring treatment escalation
timeFrame: baseline, week 8, 16 and 32
measure: Work productivity and activity impairment
timeFrame: baseline and week 16
measure: EQ-5D-5L
timeFrame: baseline, week 32
measure: Skin-specific quality of life impairment
timeFrame: week 4, week 12, week 16, week 24, week 32
measure: Implementability - App Engagement Scale
timeFrame: week 32
measure: Implementability - Frequency of app usage
timeFrame: week 8, week 32
measure: Implementability - Duration of app usage
timeFrame: week 8, week 32
measure: Implementability - Willingness to pay
timeFrame: week 32
measure: Implementability - Barriers and facilitators of use
timeFrame: Post 32 weeks after participant's study completion
measure: Implementability - Percentage completed learning paths/ modules
timeFrame: baseline to week 32
measure: Implementability - Appropriate responses and engagement to tracking exercises and open ended questions in the app
timeFrame: Baseline to week 32
measure: Implementability - Collective server statistics
timeFrame: baseline to week 32
measure: Implementability - Likely frequency of app use after study
timeFrame: week 32
measure: Implementability - Likes and dislikes
timeFrame: week 32
measure: Implementability - Suggestions and feedback
timeFrame: week 32
measure: Physician assessed global disease severity
timeFrame: baseline, week 8, week 16
measure: Physician assessed clinical global change
timeFrame: week 8, week 16
measure: Patient's disease severity grading
timeFrame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
measure: Patient Global Impression of Severity
timeFrame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
measure: Patient Global Impression of Change
timeFrame: week 4, week 8, week 12, week 16, week 24, week 32
Other outcomes:
measure: Type D personality
timeFrame: baseline and week 16
measure: Itch characteristic
timeFrame: 0, week 8
measure: Scratching behavior
timeFrame: baseline, week 8, week 16, week 24, week 32
measure: Acceptance of health condition
timeFrame: baseline, week 8, week 16, 32
measure: Revised illness perception questionnaire
timeFrame: baseline, week 8, week 16, 32
measure: Resilience
timeFrame: baseline, week 8, week 16, 24, 32
measure: Self Efficacy in managing emotions
timeFrame: baseline, week 8, 32
measure: Mindfulness
timeFrame: baseline, week 8, 32
measure: Self stigmatization
timeFrame: baseline, week 8, week 16, 32
measure: Social Comparison
timeFrame: baseline, week 8, week 16, 32
measure: Well being
timeFrame: baseline, week 8, week 16, 24, 32
measure: Adherence
timeFrame: baseline, week 8, week 16, 32
measure: Self-efficacy for managing social interactions
timeFrame: baseline, week 8, week 32
Locations:
Study officials:
affiliation: National University Hospital, Singapore
name: Ellie Choi, MBBS
role: PRINCIPAL_INVESTIGATOR
References: