NCT03991247

Evaluation of Spa Treatment on Insomnia

Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Association Francaise pour la Recherche Thermale · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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. In this context, spa treatment with psychosomatic orientation appears conducive to implement hygiene rules and structure rhythms of life. The spa treatment could therefore provide ideal conditions for the implementation of behavioral measures of insomnia management (sleep hygiene, stimulus control and time in bed restriction) and could have a very beneficial effect on persistent insomnia disorder. This non-pharmacological therapy could also reduce hypnotics consumption (especially benzodiazepine). The main hypothesis of the study is that behavioral measures of insomnia management delivered by an internet software program combined to a spa treatment will be more effective on insomnia complaints (evaluated at 8 weeks) than the same program implemented at home. Patients will be followed during 6 months after the beginning of the program. Subjects' recruitment will be carried out from the list of patients registered for a spa treatment in one of the five spa centers participating in the study (Les Thermes de Saujon, Les Grands Thermes de Bagnères de Bigorre, Les Thermes de Divonne-les-Bains, Les thermes de Néris-les-Bains, Les Thermes d'Ussat-les-Bains). Study visits will be conducted by the coordinating center (CHU Bordeaux) by telephone interviews or video calls with participants.

Conditions

• Insomnia

Interventions

Type	Name	Description
BEHAVIORAL	Computerized behavioral therapy program delivered by internet for insomnia management	The online program consists in restriction of time in bed and stimulus control instructions. First, patient will complete an on-line sleep diary during 2 weeks. The personalized program is then activated by a practitioner (phone interview) who both assesses restriction of time in bed and delivers instructions of stimulus control. Then, restriction of time in bed is administered by the internet-delivered self-help program. The participant still completes his on-line sleep diary every day. Every 7 days, according mean sleep efficiency, a new sleep schedule recommendation is given to the participant. In addition, the program delivers everyday a set of instructions (stimulus control) designed to re-associate the bed/bedroom with sleep and to re-establish a consistent sleep wake schedule. The duration of restriction of time in bed program is 3 weeks (during spa treatment or at home depending on the allocated arm).
OTHER	Spa treatment	Spa treatment is harmonized in the different stations. It consists in: * a medical thermal follow-up: weekly medical consultation of 15 minutes during the 3 weeks spa treatment. * an institutional follow-up: support, help and monitoring of patients during spa treatment * Crenotherapy: 18 baths of 10 minutes in running water, 18 spa showers of 3 minutes, 9 massages under water of 20 minutes, 18 baths of 10 minutes in pool. Water temperature of pool is between 31°C and 33°C. Water temperature for other care is 35°C and 38°C.

Timeline

• Start date: 2019-12-05
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2019-06-19
• Last updated: 2022-05-31

Locations

1 site across 1 country: France