Group Psychotherapy for Patients With Hidradenitis Suppurativa: Effects in Quality
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Dermatology Quality of Life Index (DLQI)
研究概览
简要总结
The aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.
详细描述
Further investigations studies are needed to determine the efficacy of psychological interventions for people with hidradenitis suppurativa.
The aim of this study is to determine the benefits of group psychotherapy on quality of life for people with hidradenitis suppurativa receiving medical and surgical treatment versus a control group (awaiting group) treated with medical and surgical treatment, without psychotherapy.
This is an experimental randomized trial with control group. Quality of life, symptoms: pruritus, odor and pain, distress and the illness will be measured before and after the intervention using psychological and quality of life questionnaires, and dermatological evaluations for 120 subjects.
The investigators expect that the experimental group scores at the end of the psychotherapy program will be less than 4 points in Visual Analog Scale (VAS) for pruritus, odor and pain. The Dermatology Quality of Life Index (DQLI) expected to be less than 4 points from the initial score, and the patients are expected to present less than 7 points in Hospital Anxiety and Depression Scale (HADS). The experimental group scores will be less than the control group for quality of life, symptoms and distress.
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 (Outcomes Assessor)
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
- •Men and women at least 18 years old at the time of selection.
- •Subjects diagnosed with hidradenitis suppurativa.
- •Subjects that are in dermatological treatment.
- •Patients should be able to understand and communicate with the investigator.
排除标准
- •Subjects suffering from a serious concomitant illness.
- •Subjects with a mental illness.
- •Subjects who are performing psychiatric treatment.
- •Subjects who are performing psychotherapy sessions both individual and group.
- •Patients who have alcohol dependence or drug abuse.
- •Subjects that present legal incapacity or limited legal capacity.
- •Subjects presenting illiteracy or language barriers.
结局指标
主要结局
Dermatology Quality of Life Index (DLQI)
时间窗: 1 year
The Dermatology Life Quality Index or DLQI, developed in 1994, was the first dermatology-specific Quality of Life instrument. It is a simple 10-question validated questionnaire that has been used in over 40 different skin conditions in over 80 countries and is available in over 90 languages. Its use has been described in over 1000 publications including many multinational studies. The DLQI is the most frequently used instrument in studies of randomised controlled trials in dermatology.
次要结局
- Visual analog scale (VAS) for pain(1 year)
- Hospital Anxiety and Depression Scale (HADS)(1 year)
- Visual analog scale (VAS) for pruritus(1 year)
- Hurley's staging system(1 year)
- Hidradenitis Supurativa - Physician Global Assessment (HS-PGA)(1 year)
- Visual analog scale (VAS) for odor(1 year)