An Exploratory Study to Evaluate a Digital Intervention to Disrupt Scratching in Atopic Dermatitis and Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Experience with Study App
研究概览
简要总结
CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.
DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health.
详细描述
CT-100 is a platform that provides interactive, software based therapeutic components that may be used as part of a treatment in future software-based prescription digital therapeutics. One class of CT-100 components are Digital Neuro-activation and Modulation (DiNaMo TM) components.
DiNaMo components target key neural systems (including but not limited to systems related to sensory-, perceptual-, affective-, pain-, attention-, cognitive control, social- and self- processing) to optimally improve a participant's health.
The purpose of the proposed study is to evaluate initial effects of the DiNaMo component on measures of undesired behavior intensity and related outcomes in a variety of conditions, such as atopic dermatitis and psoriasis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fluent in written and spoken English, confirmed by ability to read, understand and sign the informed consent form (ICF).
- •Lives in the United States.
- •Aged 18 years or older.
- •Itch NRS ≥ 4 during screening.
- •Meets indication-specific inclusion criteria (see Appendix 1), as reported by the study participant with adequate clinical documentation. (Documentation to be provided to the study team upon request.)
- •Has an active email address and is willing and able to receive and respond to email messages.
- •Has access to an internet connection during the study duration.
- •Willing and able to comply with the study protocol and assessments.
- •Is the sole user of an iPhone with an iPhone operating system (OS) 14 or later or a smartphone with an Android OS 10 or later for the duration of the study.
- •Is willing and able to receive Short Message Service (SMS) text messages and notifications on their smartphone.
排除标准
- •Pregnant or planning to become pregnant.
- •Visual, dexterity or cognitive deficit so severe that it precludes the use of an App-based, reaction-time-based activity per investigator judgment.
- •Severe psychiatric disorder involving a history of psychosis (e.g., schizophrenia, bipolar disorder or severe personality disorders).
- •Psychiatric hospitalization in the past 6 months.
- •Participation in any research study (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the past 3 months.
- •Initiation or change in primary-disease-specific medication within 30 days prior to entering the study.
- •Self-reported substance-use disorder within the past 1 year.
- •Currently experiencing a skin infection.
- •Planning the introduction of new therapies (including studies on psychotherapy, mindfulness, cognitive training or pharmacological treatment) during the 7-week study period.
- •Anticipating a change in current pharmacological or psychotherapy treatment regimen during the 7-week study period.
研究组 & 干预措施
CT-100-004-A Psoriasis
干预措施: CT-100-004-A (Device)
CT-100-004-B Psoriasis
干预措施: CT-100-004-B (Device)
CT-100-004-A Atopic Dermatitis
干预措施: CT-100-004-A (Device)
CT-100-004-B Atopic Dermatitis
干预措施: CT-100-004-B (Device)
结局指标
主要结局
Experience with Study App
时间窗: Week 5
Experience with the Study App as assessed by the User Experience Questionnaire after the Study App treatment period
Change in Dermatology Life Quality Index
时间窗: Baseline to Week 4
Change from baseline to Week 4 in the Dermatology Life Quality Index (DLQI)
Change in Quality of Life symptoms
时间窗: Baseline to Week 4
Change in QoL symptoms assessed with the PROMIS®-29+2 Profile v2.1 (PROMIS-29+2 Preference \[PROPr\]) scales (including mood, fatigue, pain interference, sleep, ability to participate in social functioning and cognitive function) from baseline to Week 4
Improved global rating of change
时间窗: Baseline to Week 4
Proportion of participants with an improvement as measured by the Global Rating of Change (GRC) score at Week 4
Change in Peak Pruritus Numerical Rating Scale
时间窗: Baseline to Week 4
Change from baseline to Week 4 in the Peak Pruritus Numerical Rating Scale (PP-NRS)
Time in App
时间窗: Baseline to Week 4
Engagement with the App as measured by daily time in the App
次要结局
- Severity of Adverse Events(Baseline to Week 5)
- Frequency of Adverse Events(Baseline to Week 5)
- Severity of Serious Adverse Events(Baseline to Week 5)
- Frequency of Serious Adverse Events(Baseline to Week 5)