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

Официальное название

Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Digital psychotherapeutic intervention
  Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
• Поведенческое Healthy365
  Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.

Первичные конечные точки

• Skin-specific quality of life impairment [Срок оценки: baseline, week 8]

Вторичные конечные точки (12)

• Physician assessed body surface area affected [Срок оценки: baseline, week 8 and 16]
• Investigator/physician global assessment [Срок оценки: baseline, week 8, week 16]
• Eczema severity [Срок оценки: baseline, week 8, week 16]
• Psoriasis Severity [Срок оценки: baseline, week 8, week 16]
• Chronic urticaria severity [Срок оценки: baseline, week 8, week 16]
• Composite measure of scratching [Срок оценки: baseline, week 8, week 16]
• Itch [Срок оценки: baseline, weeks 4, 8, 12, 16, 24, 32]
• Skin pain [Срок оценки: baseline, week 4, week 8, week 12, week 16, week 24, week 32]
• Sleep disturbance [Срок оценки: baseline, weeks 4, 8, 12, 16, 24, 32]
• Depression [Срок оценки: baseline, week 8, week 16, week 24 and 32]
• Anxiety [Срок оценки: baseline, weeks 8, 16, 24 and 32]
• Number of patients requiring treatment escalation [Срок оценки: baseline, week 8, 16 and 32]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Сингапур · 1 центр

• National University Hospital — Singapore

Публикации

• 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

Идентификаторы

NCT: NCT06702293 · 2022/00751

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗