National University Hospital
Singapore, 609783
Location status: Recruiting
NCT Number: NCT06702293
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.
Interested in participating?
Request Info16 year and older
All sexes
Interventional
Not applicable
Singapore, 609783
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
o Hospital inpatient admission for a psychiatric condition or initiation of a psychotropic medication in the prior 3 months
Mobile app comprising various psychobehavioural tools to educate, enhance self-efficacy and coping and promote wellness in dermatological patients.
Other names: mobile app
Mobile application by the Health Promotion Board (HPB) Singapore which aims to encourage users to adopt a healthier lifestyle.
Time frame: baseline, week 8
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (extremely large impact on quality of life).
Time frame: baseline, week 8 and 16
Range from 0% (no affected area) to 100% (complete involvement)
Time frame: baseline, week 8, week 16
0 to 5 point numerical rating scale, with a higher value signalling greater severity
Time frame: baseline, week 8, week 16
Eczema Area and Severity Index. Scoring system used to assess the severity of atopic dermatitis. Score ranges from 0 to 72 with higher score indicating worse severity.
Time frame: baseline, week 8, week 16
Psoriasis Area and Severity Index. Severity assessment for patients with psoriasis. Score ranges from 0-72 with higher scoring indicating more severe disease.
Time frame: baseline, week 8, week 16
Urticaria Activity Score-7 (UAS7). Assess severity for patients with chronic urticaria. Score ranges from 0-6.
Time frame: baseline, week 8, week 16
Global severity and body surface area affected of various scratching measures e.g excoriation, lichenification, prurigo
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
0-10 numerical rating scale, with higher scores signalling greater itch
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
0-10 numerical rating scale, greater scores signalling greater pain
Time frame: baseline, weeks 4, 8, 12, 16, 24, 32
0-10 numerical rating scale, with higher scores signalling greater sleep disturbance
Time frame: baseline, week 8, week 16, week 24 and 32
PROMIS (Patient-Reported Outcomes Measurement Information System) Depression 8b. The raw score range for the PROMIS Depression 8b ranges from 8 to 40 with higher scores indicating greater depressive symptoms. The raw score is then converted to a T-score using a standardized conversion table. The T scores have a mean of 50 and standard deviation (SD) of 10, a higher value signals greater depressive symptoms.
Time frame: baseline, weeks 8, 16, 24 and 32
PROMIS (Patient-Reported Outcomes Measurement Information System) Anxiety 7a. The raw score range from 7-35 with higher scores indicating greater anxiety symptoms. The raw score is then converted to a T-score using a standardized conversion table. The T scores have a mean of 50 and standard deviation (SD) of 10, a higher value signals greater depressive symptoms.
Time frame: baseline, week 8, 16 and 32
Number of patients requiring treatment escalation, defined as any of the following
Time frame: baseline and week 16
Modified Work Productivity and Activity Impairment Questionnaire plus Classroom Impairment Questions: SHP, Version 2 (WPAI+CIQ:SHP, V 2). Assesses the impact of health problems on a person's ability to work and perform regular daily activities. Scores are multiplied by 100 to express in percentages with higher scorings indicating greater impairment and less productivity.
Two additional questions assessing time spent on problems associated with skin condition and employment status, respectively.
Time frame: baseline, week 32
EuroQol Group EQ-5D is a measure of health state/health utility. EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state
Time frame: week 4, week 12, week 16, week 24, week 32
Dermatology Life Quality Index (DLQI). Minimum Score: 0 (no impact on quality of life). Maximum Score: 30 (large impact on quality of life).
Time frame: week 32
App Engagement Scale. 7 questions graded on a likert scale. Items are summed, with scores ranging from 7 to 35, with a higher score indicating greater engagement.
Time frame: week 8, week 32
Frequency of using the mobile app, ranging from never to everyday
Time frame: week 8, week 32
Average duration of app use each time, ranging from less than 2 minutes to more than 40 minutes.
Time frame: week 32
Single bounded willingness to pay, 'How much would you maximally be willing to pay/month to continue using this mobile app?' with responses ranging from 'I would not use it even if free' to 'I would pay $41 or more /month'
Time frame: Post 32 weeks after participant's study completion
Qualitative interviews with thematic analysis to determine barriers and facilitators of use and long term sustainability
Time frame: baseline to week 32
Passively collected in mobile app's logs.
Time frame: Baseline to week 32
Passive collected in mobile app's logs.
Time frame: baseline to week 32
Mobile app's collective server access statistics is tracked to determine which pages have the lowest and highest traffic and to analyse 'helpfulness' ratings of each module.
Time frame: week 32
Likely frequency of app usage after the study, ranging from never to everyday.
Time frame: week 32
Two free-text questions collecting qualitative feedback on participants' likes and dislikes about the app, respectively.
Time frame: week 32
Free-text question collecting suggestions and feedback to improve the mobile app.
Time frame: baseline, week 8, week 16
Assesses patient's overall, emotional, functional, and physical severity, and physician's perception of how the patient graded overall severity. Range from 0 to 10, with higher value signalling greater severity.
Time frame: week 8, week 16
Clinician-assessed change in patient's overall status since the start of the study. Ranges from very much improved to very much worse.
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
A question assessing patient's overall global assessment of disease severity, ranging from 0 to 10, with higher scores indicating higher severity.
Time frame: baseline, week 4, week 8, week 12, week 16, week 24, week 32
Patient reported global severity rating, ranging from none to very severe.
Time frame: week 4, week 8, week 12, week 16, week 24, week 32
Patient reported change in overall status from the start of the study, ranging form very much improved to very much worse.
Time frame: baseline and week 16
DS-14, measure of type D personality. The negative affect and social inhibition scales are scored from 0-28 with a higher score representing greater trait. A cutoff of 10 on each scale is used to classify type D personality.
Time frame: 0, week 8
5D Pruritus scale ranges from 5 to 25, where 5 indicates no pruritus and 25 indicates the most severe pruritus.
Time frame: baseline, week 8, week 16, week 24, week 32
PROMIS Itch Questionnaire Scratching Behaviour 5a. Score ranges fro 0-25 with higher score indicating greater scratching behaviours. Scores are standardized with 50 representing the mean.
Time frame: baseline, week 8, week 16, 32
Acceptance of Chronic Health Conditions Scale. Scores range from 8 to 40. Higher scores indicate greater acceptance of the chronic health condition.
Time frame: baseline, week 8, week 16, 32
Assessment of how individuals perceive their illness including cognitive and emotional representations of illness across several dimensions. Each dimension is scored separately and expressed as a percentage (0-100%), with higher scores indicating more strongly held beliefs.
Time frame: baseline, week 8, week 16, 24, 32
Brief Resilience Scale. The total score on the Brief Resilience Scale (BRS) ranges from 6 to 30. This scale measures an individual's ability to bounce back from stress and adversity. A higher score indicates greater resilience, while a lower score suggests lower resilience.
Time frame: baseline, week 8, 32
PROMIS self-efficacy in managing emotions 4a. Score ranges from 4 to 20 which are standardized and expressed as a percentage from 0-100%, with higher score indicating greater self efficacy.
Time frame: baseline, week 8, 32
2 questions from the Cognitive and Affective Mindfulness Scale- Revised (CAMS-R). Score ranges from 0-6 with higher score indicating more mindfulness.
Time frame: baseline, week 8, week 16, 32
Weight bias internalization scale, modified for skin conditions. The score ranges from 11 to 77. Higher scores indicate greater internalization of bias/negative perception towards self.
Time frame: baseline, week 8, week 16, 32
The DermSC scale comprises 3 questions, testing the general tendency for social comparison, downward negative comparison and upward negative comparison. The scores of each question (1-5 points) are tabulated (range 3-15) with a higher score indicating a greater degree of social comparison.
Time frame: baseline, week 8, week 16, 24, 32
World Health Organisation-Five Well-Being Index (WHO-5) ranges from 0-25 which is converted to an index score 0-100 with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Time frame: baseline, week 8, week 16, 32
Self-reported treatment adherence, represented as a percentage from 0-100% where higher scores indicate greater adherence.
Time frame: baseline, week 8, week 32
2 questions from PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Social Interactions. It assesses confidence in social activities and help seeking, ranging from I am not at confident to I am very confident.
Contact information is provided by the study sponsor or research team.
National University Hospital, Singapore
Other
Development and Testing of a Digital Psychological Tool to Improve Symptom Burden in Dermatology Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07481019
Acne, Acne Vulgaris
View Trial DetailsNCT05461456
Atopic Dermatitis, Atopic Dermatitis Eczema
Dhaka, Ramna, Bangladesh
View Trial DetailsNCT06999941
Dermatitis, Eczema
Shanghai, Shanghai Municipality, China
View Trial DetailsNCT06583395
Adnexal Diseases, Amyotrophic Lateral Sclerosis
Palm Desert, California, United States
View Trial Details