Effectiveness of Group Psychotherapy in Patients With Narcolepsy Type 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Fatigue (Severity)
研究概览
简要总结
The aim of this pilot study is to test the benefit of behavior therapy-oriented, method-integrated psychotherapy in an outpatient group setting in patients with narcolepsy type 1. Therefore we collect and evaluate initial data on its effectiveness on the disease in terms of specific symptomatology, emotion regulation, health-related quality of life, and disease processing/acceptance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Diagnosed narcolepsy type 1 according to AASM, examined by an experienced sleep physician including history, clinical examination, polysomnographic examination (PSG) with a multiple sleep latency test (MSLT), possibly also including determination of HLA DQB1 * 062 and orexin A / hypocretin 1
- •Age between 18 and 65 years
- •Signed informed consent
- •Exclusion of other clinically relevant organic sleep disorders by means of polysomnography (AHI>10/h)
排除标准
- •Presence of severe psychiatric comorbidity
- •Other psychotherapy during the study period
- •Change of medication used for narcolepsy therapy shortly before the start and during the study period including follow-up measurement. In this case, patients may still complete group therapy, but the data will not be included in the analysis.
研究组 & 干预措施
Intervention
Group psychotherapy
干预措施: Group psychotherapy (Behavioral)
结局指标
主要结局
Fatigue (Severity)
时间窗: Week 0-24
German version of the questionnaire "Fatigue Severity Scale" (FSS; Valko et al., 2008)
Daytime sleepiness
时间窗: Week 0, Week 6, Week 12, Week 24
German version of the questionnaire "Epworth Sleepiness Scale" (ESS; Johns, 1991)
Sleep quality
时间窗: Week 0-24
German version of the questionnaire "Pittsburgh Sleep Quality Index" (PSQI; Buysse et al., 2008)
Emotion regulation
时间窗: Week 0-24
German questionnaire "Fragebogen zur Erhebung der Emotionsregulation bei Erwachsenen" (FEEL-E; Grob et al., 2014)
次要结局
- Disease processing, acceptance & coping(Week 0, Week 6, Week 12, Week 24)
- Anxiety & depression(Week 0, Week 6, Week 12, Week 24)
- Health-related quality of life (HRQOL)(Week 0-24)
研究者
Nicolas Germann
Principal Investigator
Cantonal Hospital of St. Gallen