Use of a Digital Psychotherapeutic App to Reduce Symptom Burden in Dermatology Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digital psychotherapeutic intervention, Healthy365.
- Who it may be relevant to
- Registry conditions: Eczema, Psoriasis, Urticaria. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
Overview
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.
Interventions
- Behavioral Digital psychotherapeutic intervention
Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients. - Behavioral Healthy365
Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.
Primary outcome measures
- Skin-specific quality of life impairment [Time frame: baseline, week 8]
Secondary outcome measures (12)
- Physician assessed body surface area affected [Time frame: baseline, week 8 and 16]
- Investigator/physician global assessment [Time frame: baseline, week 8, week 16]
- Eczema severity [Time frame: baseline, week 8, week 16]
- Psoriasis Severity [Time frame: baseline, week 8, week 16]
- Chronic urticaria severity [Time frame: baseline, week 8, week 16]
- Composite measure of scratching [Time frame: baseline, week 8, week 16]
- Itch [Time frame: baseline, weeks 4, 8, 12, 16, 24, 32]
- Skin pain [Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32]
- Sleep disturbance [Time frame: baseline, weeks 4, 8, 12, 16, 24, 32]
- Depression [Time frame: baseline, week 8, week 16, week 24 and 32]
- Anxiety [Time frame: baseline, weeks 8, 16, 24 and 32]
- Number of patients requiring treatment escalation [Time frame: baseline, week 8, 16 and 32]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Supportive care
Study locations
Singapore · 1 center
- National University Hospital — Singapore
Publications
- 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
Identifiers
NCT: NCT06702293 · 2022/00751