A Randomised Control Trial of Integrative Cognitive Behavioural Therapy for Alopecia: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Perceived Stress Scale (PSS)
研究概览
简要总结
This Randomised Control Trial (RCT) aims to test a novel Alopecia-tailored, protocolled, integrative individual psychological intervention offered to patients with enduring Alopecia. The pilot study aims to assess the impact of the intervention on 8 patients, by assessing changes in their psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to 7 patients in the wait-list control group.
详细描述
Alopecia is a stress-related auto-immune skin condition that results in hair-loss on the scalp and around the body. This pilot RCT aims to test a newly developed Alopecia-specific, psychological intervention with 8 patients diagnosed with enduring Alopecia. The intervention is an Integrative Cognitive Behavioural Therapy, implemented through a protocolled programme entailing 12 weeks of hourly individual sessions. The trial will be delivered at The Dermatology Department at the Royal Free Hospital in Hampstead, London. The pilot study aims to evaluate the impact of the intervention on patients' psychological and physical symptoms (stress, anxiety, depression, quality of life, scalp hair, and other bio-markers) compared to the wait-list control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participants are not aware of their allocation to the intervention group or control group. All
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
- •Diagnosis of Alopecia received by medical profession over 1 year prior to beginning trial
- •Fluent in Written and Verbal English
排除标准
- •Another more dominant skin condition
- •Another more dominant severe and enduring mental illness
- •Women who are pregnant
- •Learning difficulties, brain injuries or dementia
- •Drug and alcohol dependency
- •Received therapy in the last year
结局指标
主要结局
Perceived Stress Scale (PSS)
时间窗: 12 weeks
Psychological Measure: Self-reported questionnaire measuring perceived stress
Hospital Anxiety And Depression Scale (HADS)
时间窗: 12 weeks
Psychological Measure: Self-reported questionnaire assessing anxiety and depressive symptoms
Dermatology Life Quality Index (DLQI)
时间窗: 12 weeks
Psychological Measure: Self-reported questionnaire measuring impact of Alopecia on participants quality of life
Severity of Alopecia Tool (SALT) Scalp Assessment
时间窗: 12 weeks
Physical Measure: Percentage of total hair loss
Blood Test
时间窗: 12 weeks
Physical Measure: Thyroid Stimulating Hormone Serum (Munit/ L) and Ferritin Serum (Micrograms)
次要结局
- Physical Measures(12 weeks)