Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 178
- 试验地点
- 2
- 主要终点
- Insomnia Severity Scale (ISI) score
研究概览
简要总结
Persistant insomnia is a common sleep disorder that affects approximately 20% of the French population. The standard treatment for chronic insomnia is Cognitive-Behavioral Therapy (CBT).
Behavioral measures can be difficult to implement for the patient alone at home.
Spa therapy with psychosomatic orientation allows to implement hygiene rules and structure rhythms of life. In addition, recent studies have shown that spa treatment, including crenotherapy, is effective in somatic complaints related to anxiety and benzodiazepine withdrawal.
The spa treatment could therefore provide ideal conditions for the implementation of behavioral measures for insomnia management.
The objective of SOMNOTHERM study is to measure efficiency on insomnia complaints at 8 weeks of a the implementation of a Behavioral therapy program for insomnia delivered by an internet software combined to a spa treatment compared to implementation of the same program at home (standard care).
详细描述
Persistant insomnia is a common sleep disorder that affects approximately 20% of the French population.
The standard treatment for chronic insomnia is Cognitive-Behavioral Therapy (CBT). This therapy is based on 4 components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene education. Unfortunately, there are an insufficient number of trained CBT experts especially in France.
Online programs based on CBT principles (e-CBT) have been proved to be effective in improving the sleep and daytime functioning in this population. Thus e-CBT can be an effective alternative to conventional CBT.
Behavioral measures, however, remains difficult for patients to implement alone at home.
Spa therapy with psychosomatic orientation allows to implement hygiene rules and structure rhythms of life. In addition, recent studies have shown that spa treatment, including crenotherapy, is effective in somatic complaints related to anxiety and benzodiazepine withdrawal.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 18 and 80 years old
- •Registered at one of the participating spas, for a psychosomatic spa treatment scheduled for the next 12 months, but within a period of more than 16 weeks.
- •ISI score ≥ 8 on the pre-selection questionnaire
- •Person with a persistent insomnia disorder, with or without comorbidities, according to DSM 5
- •Owning or having access to a computer / tablet or smartphone and to an internet connection
- •Affiliated to a national health service
- •Having given written informed consent to participate in the trial.
排除标准
- •Strong suspicion of obstructive sleep apnea (OSA) syndrome on the STOP-BANG questionnaire and restless legs syndrome on the RLS screening questionnaire
- •Having started antidepressant treatment in the last 2 months or whose treatment dose has been increased in the last 2 months
- •Having started treatment with anxiolytic, hypnotic or neuroleptic in the last month or whose dosage of treatment has been increased in the last month
- •Having carried out a spa treatment in the last 6 months, whatever the specialty.
- •Registered to follow a complementary program for insomnia disorders during the planned spa treatment
- •Pregnant or lactating women
- •Major under guardianship or curatorship
- •Night and shift-workers
- •Having undertaken trans-meridian travel (± 3H) in the previous 1 month
结局指标
主要结局
Insomnia Severity Scale (ISI) score
时间窗: Week 10 = 8 weeks after beginning of computerized behavioral therapy (starting of time in bed restriction)
7-item questionnaire assessing insomnia nature, severity and impact. The global score ranges from 0 to 28.
次要结局
- Sleep latency obtained by sleep diary(Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination))
- Insomnia Severity Scale (ISI) score(On Day 0, Week 5, Week 7, Month 4, Month 6)
- The Presleep State Arousal Scale (PSAS)(On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6)
- Hospital Anxiety and Depression Scale (HAD)(On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6)
- The Pittsburgh Sleep Quality Index (PSQI)(On Day 0)
- Cognitive Scale of Attachment to Benzodiazepines ("Echelle cognitive d'attachement aux benzodiazépines" ECAB)(On Day 0)
- The Epworth Sleepiness Scale (ESS)(On Day 0)
- Krueger's personality inventory for DSM-5 in its brief form (PID-5-BF)(On Day 0)
- The Ford Insomnia to Stress Scale (FIRST)(On Day 0)
- The "locus of control for technology"-questionnaire ("Kontrollüberzeugungen im Umgang mit Technik" - KUT)(On Day 0)
- Total sleep time (TST) obtained by sleep diary(Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination))
- Client Satisfaction Questionnaire (CSQ-8)(On week 10 (after computerized behavioral therapy program))
- Sleep Condition Indicator (SCI)(On Day 0)
- The Munich ChronoType Questionnaire (MCTQ)(On Day 0)
- The Arousal Predisposition Scale (APS)(On Day 0)
- Sleep efficiency (SE) obtained by sleep diary(Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination))
- Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ)(On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6)
- EQ-5-D(On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6)
- Rate of discontinuation and rate of reduction of anxiolytic hypnotic drugs and hypnotics(On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6)
- Acceptability E-scale (AES)(On week 10 (after computerized behavioral therapy program))
- Freiburg Mindfulness Inventory - short version (FMI)(On Day 0)