Clinical trial NCT03991247: Evaluation of Spa Treatment on Insomnia
Official title: Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia
Keywords: Spa treatment
Cognitive Behavioral Therapy
Internet delivered self-help program
Insomnia
Sleep restriction
stimulus control
crenotherapy
Lead sponsor: Association Francaise pour la Recherche Thermale
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: University of Bordeaux
First posted: 2019-06-19
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Insomnia Severity Scale (ISI) score
timeFrame: Week 10 = 8 weeks after beginning of computerized behavioral therapy (starting of time in bed restriction)
Secondary outcomes:
measure: Total sleep time (TST) obtained by sleep diary
timeFrame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
measure: Sleep efficiency (SE) obtained by sleep diary
timeFrame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
measure: Sleep latency obtained by sleep diary
timeFrame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination)
measure: Insomnia Severity Scale (ISI) score
timeFrame: On Day 0, Week 5, Week 7, Month 4, Month 6
measure: EQ-5-D
timeFrame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
measure: The Presleep State Arousal Scale (PSAS)
timeFrame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
measure: Hospital Anxiety and Depression Scale (HAD)
timeFrame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
measure: Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ)
timeFrame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
measure: Rate of discontinuation and rate of reduction of anxiolytic hypnotic drugs and hypnotics
timeFrame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6
measure: Acceptability E-scale (AES)
timeFrame: On week 10 (after computerized behavioral therapy program)
measure: Client Satisfaction Questionnaire (CSQ-8)
timeFrame: On week 10 (after computerized behavioral therapy program)
measure: Sleep Condition Indicator (SCI)
timeFrame: On Day 0
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: On Day 0
measure: Cognitive Scale of Attachment to Benzodiazepines ("Echelle cognitive d'attachement aux benzodiazépines" ECAB)
timeFrame: On Day 0
measure: The Munich ChronoType Questionnaire (MCTQ)
timeFrame: On Day 0
measure: The Epworth Sleepiness Scale (ESS)
timeFrame: On Day 0
measure: Freiburg Mindfulness Inventory - short version (FMI)
timeFrame: On Day 0
measure: Krueger's personality inventory for DSM-5 in its brief form (PID-5-BF)
timeFrame: On Day 0
measure: The Arousal Predisposition Scale (APS)
timeFrame: On Day 0
measure: The Ford Insomnia to Stress Scale (FIRST)
timeFrame: On Day 0
measure: The "locus of control for technology"-questionnaire ("Kontrollüberzeugungen im Umgang mit Technik" - KUT)
timeFrame: On Day 0
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
Study officials:
References: