Mindfulness-based Cognitive Therapy for Psoriasis Patients With Anxiety and Depression
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline on the Psoriasis Area and Severity Index (PASI)
研究概览
简要总结
This study investigates the effectiveness of a 24-week mindfulness intervention in reducing symptoms in psoriasis patients with anxiety and depression.
详细描述
An adapted MBCT intervention will be offered to people with psoriasis with depression and/or anxiety. 8-week long MBCT therapy will be held between August 2021 and Jan 2022, based on the adapted protocol. The MBCT intervention will consist of 30-minute weekly groups focused on teaching mindfulness techniques and ways to recognize cognitive patterns that can increase anxiety and/or depression. Participants will be recruited from the community, according to the eligibility criteria detailed below. For all participants, anxiety and/or depressive symptom severity(SAS/SDS), PASI,DLQI,(as measured with standardized, validated scales) will be compared baseline and weeks 2;4;8;12;16;20;24. Itch intensity ,itch perception ,quality of sleep, hours missing at work ,helpfulness of common itch therapies serve as the secondary outcome, using a paired t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the age ranged from 18 to 70 years old
- •fulfilled the Classification Criteria for Psoriasis
- •the score of the SDS > 50 and / or SAS >50
- •Participant has normal or corrected to normal vision and hearing
- •Participant is willing and able to give informed consent for participation in the study.
排除标准
- •Participant has insufficient manual dexterity for the computerized tasks
- •severe systemic diseases
- •patients with severe mental illness or taking psychotic drugs
- •Pregnancy
- •No access to the internet
结局指标
主要结局
Change from Baseline on the Psoriasis Area and Severity Index (PASI)
时间窗: Baseline and Week 2;4;8;12;16;20;24
PASI a measurement that combines severity of lesions and the area affected in one score that ranges from 0 to 72 .
Change from Baseline on the Self-rating Depression Scale (SDS)
时间窗: Baseline and Week 2;4;8;12;16;20;24
In the main component of the SDS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4.
Change from Baseline on the Dermatology Life Quality Index (DLQI)
时间窗: Baseline and Week 2;4;8;12;16;20;24
The DLQI is a 10-item questionnaire measuring the effect of dermatological diseases on patients over the last week. The DLQI total score is the sum of each individual item score and ranges from 0 or 1 to 30 .
Change from Baseline on the Self-rating Anxiety Scale (SAS).
时间窗: Baseline and Week 2;4;8;12;16;20;24
In the main component of the SAS , patients are asked 20 questions about Mental and physical feelings of emotional experience, and the patients determine the quality of emotion by selecting one of the options: Occasionally=1, sometimes=2, often=3, and continuously=4. The total score is multiplied by an integer of 1.25 to get the standard score.
次要结局
- Itch perception(Baseline)
- Hours missing at work(Baseline and Week 2;4;8;12;16;20;24)
- Helpfulness of common itch therapies(Baseline and Week 2;4;8;12;16;20;24)