Smart Phone Delivered Cognitive Behavioral Therapy for Adults With Psoriasis and Co-Morbid Depression Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Participants Engagement
研究概览
简要总结
A single arm, pilot study in which all eligible participants will be enrolled in an 8-week coach-guided smartphone delivered CBT program. The full duration of the program, with follow-up interview, will be 9 weeks.
详细描述
- To demonstrate the feasibility and acceptability of coach-guided, smartphone-delivered CBT for depression among adults with psoriasis
- To demonstrate the preliminary efficacy of coach-guided, smartphone-delivered CBT on the symptoms of depression and psoriasis
Primary endpoints
- Percentage of participants who engage with at least 6/8 (75%) modules
- Median Client Satisfaction Questionnaire-8 score at week 8
- Change from baseline in PHQ-9 at week 8
Secondary Endpoints
- Rate of participant dropout
- App acceptability to participants, as measured by the uMARS
- Change from baseline in Skindex-16 at week 8
- Change from baseline in PSI at week 8
- Change from baseline in AAI at week 8
- Frequency & severity of related adverse events
- The patient perspective on the feasibility and acceptability (qualitative)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •• Adults aged 18 years of age and older
- •Dermatologist confirmed diagnosis of psoriasis
- •Current depression symptoms, defined as a PHQ-9 score of 5 or greater
- •Current psoriasis symptoms, defined as a scaled score of "mild" on any of the Skindex-16 subscales
- •Participants must be proficient in English and have access to an Android or iOS smartphone
排除标准
- •Previous participation in CBT for depression
- •Current participation in any type of psychotherapy
- •Those on psychotropic medications must be taking a stable dose for 2 months prior to enrollment and be willing to remain at a stable dose during the 8-week study
- •Current elevated suicide risk (see Section 5.3 for details)
- •Individuals who are incarcerated or compulsory detained
- •Any uncontrolled or poorly controlled chronic medical condition that may interfere with an individual's ability to participate in the clinical trial
结局指标
主要结局
Participants Engagement
时间窗: from Baseline to 8 Weeks
Percentage of participants who engage with at least 6/8 (75%) modules within the app
Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: change from baseline to Week 8
The CSQ-8 is an 8 item, self-reported questionnaire that measures satisfaction with clinical services received on a 1-4 scale. Scores are summed across items once. Items 2, 4, 5, and 8 are reverse scored. Total scores range from 8 to 32, with the higher number indicating greater satisfaction .
Patient Health Questionaire-9 (PHQ-9)
时间窗: Week 8
The PHQ-9 is a widely used, reliable, and valid self-report measure of depression severity, It includes nine Likert scale items ranging from 0 (not at all) to 3 (every day), where higher scores indicate more severe depressive symptoms.
次要结局
- Skindex-16(Week 8)
- Appearance Anxiety Inventory (AAI)(Week 8)
- Frequency of participants with adverse events(Week 8)
- Rate of participant dropout(Week 8)
- user Mobile Health Rating Scale (uMARS)(Week 8)
- Psoriasis Symptom Inventory(Week 8)
研究者
John Barbieri
Assistant Professor
Brigham and Women's Hospital