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Trial record 30 of 165 for:    personality AND therapy AND severity | Recruiting, Not yet recruiting, Available Studies

Evaluation of Spa Treatment on Insomnia (SOMNOTHERM)

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ClinicalTrials.gov Identifier: NCT03991247
Recruitment Status : Not yet recruiting
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborators:
University Hospital, Bordeaux
University of Bordeaux
Information provided by (Responsible Party):
Association Francaise pour la Recherche Thermale

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).


Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Computerized behavioral therapy program delivered by internet for insomnia management Other: Spa treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Psychosomatic Spa Treatment With Crenotherapy to Potentiate the Implementation of Behavioral Measures for Insomnia Disorder Management
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Experimental: Internet Behavioral therapy program + spa therapy
Patient following a program of computerized behavioral therapy for insomnia management during a 3 weeks spa treatment.
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.

Active Comparator: Internet Behavioral therapy program at home
Patient following a program of computerized behavioral therapy for insomnia management during 3 weeks at home.
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).





Primary Outcome Measures :
  1. Insomnia Severity Scale (ISI) score [ Time Frame: 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.


Secondary Outcome Measures :
  1. Total sleep time (TST) obtained by sleep diary [ Time Frame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination) ]
    Total sleep time = total sleep episode minus awake time. Subject records in his online sleep diary bedtime, wake-up time, time asleep, intra-night awakenings.

  2. Sleep efficiency (SE) obtained by sleep diary [ Time Frame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination) ]

    Ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage).

    Subject records in his online sleep diary bedtime, wake-up time, time asleep, intra-night awakenings.


  3. Sleep latency obtained by sleep diary [ Time Frame: Every night between starting of sleep diary completion (Day 0) and Month 6 (study termination) ]
    Length of time to accomplish the transition from full wakefulness to sleep. Subject records in his online sleep diary bedtime, wake-up time, time asleep, intra-night awakenings.

  4. Total sleep time (TST) obtained by actimetry [ Time Frame: Every night between starting of sleep diary completion (Day 0) and Week 2 ]
    Total sleep time = total sleep episode minus awake time. Actimeter monitors body movements and allows calculation of nocturnal sleep episodes and nocturnal awakenings. Actimeter is placed on a wrist. Time in bed is computed as the time difference between going to bed in the evening and getting up in the morning.

  5. Total sleep time (TST) obtained by actimetry [ Time Frame: Every night between Week 5 and Week 7 (after the end of computerized behavioral therapy). ]
    Total sleep time = total sleep episode minus awake time. Actimeter monitors body movements and allows calculation of nocturnal sleep episodes and nocturnal awakenings. Actimeter is placed on a wrist. Time in bed is computed as the time difference between going to bed in the evening and getting up in the morning.

  6. Sleep efficiency (SE)obtained by actimetry [ Time Frame: Every night between starting of sleep diary completion (Day 0) and Week 2 ]

    Ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage).

    Actimeter monitors body movements and allows calculation of nocturnal sleep episodes and nocturnal awakenings. Actimeter is placed on a wrist. Time in bed is computed as the time difference between going to bed in the evening and getting up in the morning.


  7. Sleep efficiency (SE) obtained by actimetry [ Time Frame: Every night between Week 5 and Week 7 (after the end of computerized behavioral therapy). ]

    Ratio of total sleep time (TST) to time in bed (TIB) (multiplied by 100 to yield a percentage).

    Actimeter monitors body movements and allows calculation of nocturnal sleep episodes and nocturnal awakenings. Actimeter is placed on a wrist. Time in bed is computed as the time difference between going to bed in the evening and getting up in the morning.


  8. Sleep latency obtained by actimetry [ Time Frame: Every night between starting of sleep diary completion (Day 0) and Week 2 ]
    Length of time to accomplish the transition from full wakefulness to sleep. Actimeter monitors body movements and allows calculation of nocturnal sleep episodes and nocturnal awakenings. Actimeter is placed on a wrist. Time in bed is computed as the time difference between going to bed in the evening and getting up in the morning.

  9. Sleep latency obtained by actimetry [ Time Frame: Every night between Week 5 and Week 7 (after the end of computerized behavioral therapy). ]
    Length of time to accomplish the transition from full wakefulness to sleep. Actimeter monitors body movements and allows calculation of nocturnal sleep episodes and nocturnal awakenings. Actimeter is placed on a wrist. Time in bed is computed as the time difference between going to bed in the evening and getting up in the morning.

  10. Insomnia Severity Scale (ISI) score [ Time Frame: On Day 0, Week 5, Week 7, Month 4, Month 6 ]
    7-item questionnaire that assesses insomnia nature, severity and impact.

  11. EQ-5-D [ Time Frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6 ]
    Standardized instrument for measuring generic health status.

  12. The Presleep State Arousal Scale (PSAS) [ Time Frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6 ]
    16-item questionnaire assessing whether the respondent experienced somatic (8 items, eg heart rate) or cognitive hyperarousal (eg racing thoughts) at bedtime

  13. Hospital Anxiety and Depression Scale (HAD) [ Time Frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6 ]
    14-item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.

  14. Short Version of the Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6 ]
    10 item questionnaire assessing the impact of excessive sleepiness on activities of daily living

  15. Rate of discontinuation and rate of reduction of anxiolytic hypnotic drugs and hypnotics [ Time Frame: On Day 0, Week 5, Week 7, Week 10, Month 4, Month 6 ]
    Every day anxiolytic hypnotic drugs and hypnotics daily dose

  16. Acceptability E-scale (AES) [ Time Frame: On week 10 (after computerized behavioral therapy program) ]
    6-item self-reported questionnaire that evaluates the extent to which patients find E-health systems acceptable

  17. Client Satisfaction Questionnaire (CSQ-8) [ Time Frame: On week 10 (after computerized behavioral therapy program) ]
    8-item questionnaire easily scored and administered measurement that is designed to measure client satisfaction with services.

  18. Sleep Condition Indicator (SCI) [ Time Frame: On Day 0 ]
    brief 8-item scale which measures sleep problems against the DSM-5 criteria for insomnia disorder

  19. The Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: On Day 0 ]
    self-report questionnaire that assesses sleep quality over a 1-month time interval

  20. Cognitive Scale of Attachment to Benzodiazepines ("Echelle cognitive d'attachement aux benzodiazépines" ECAB) [ Time Frame: On Day 0 ]
    10-item scale assessing cognitive component of attachment to benzodiazepines

  21. The Munich ChronoType Questionnaire (MCTQ) [ Time Frame: On Day 0 ]
    Questionnaire to determine Chrono Type.

  22. The Epworth Sleepiness Scale (ESS) [ Time Frame: On Day 0 ]
    8-item questionnaire assessing daytime sleepiness

  23. Freiburg Mindfulness Inventory - short version (FMI) [ Time Frame: On Day 0 ]
    questionnaire for measuring mindfulness

  24. Krueger's personality inventory for DSM-5 in its brief form (PID-5-BF) [ Time Frame: On Day 0 ]
    25-item self-report questionnaire assessing the presence and severity of the five maladaptive personality traits outlined in DSM-5.

  25. The Arousal Predisposition Scale (APS) [ Time Frame: On Day 0 ]
    12-item questionnaire assessing whether the respondent considers her/himself a stressful and emotionally reactive person

  26. The Ford Insomnia to Stress Scale (FIRST) [ Time Frame: On Day 0 ]
    9-item questionnaire assessing whether past and future stressful events are likely to affect sleep quality

  27. The "locus of control for technology"-questionnaire ("Kontrollüberzeugungen im Umgang mit Technik" - KUT) [ Time Frame: On Day 0 ]
    8-item questionnaire assessing the specific interaction with technical environments of users



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03991247


Contacts
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Contact: Jean-Arthur MICOULAUD-FRANCHI, MDPhD 557820173 ext +33 jean-arthur.micoulaud-franchi@chu-bordeaux.fr
Contact: Cécile KLOCHENDLER 557821159 ext +33 cecile.klochendler@chu-bordeaux.fr

Locations
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France
University Hospital, Bordeaux Not yet recruiting
Bordeaux, France, 33000
Contact: Jean-Arthur MICOULAUD-FRANCHI, MDPhD    557820173 ext +33    jean-arthur.micoulaud-franchi@chu-bordeaux.fr   
Contact: Cécile KLOCHENDLER    557821159 ext +33    cecile.klochendler@chu-bordeaux.fr   
Principal Investigator: Jean-Arthur MICOULAUD-FRANCHI, MDPhD         
Sponsors and Collaborators
Association Francaise pour la Recherche Thermale
University Hospital, Bordeaux
University of Bordeaux

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Responsible Party: Association Francaise pour la Recherche Thermale
ClinicalTrials.gov Identifier: NCT03991247     History of Changes
Other Study ID Numbers: C2018-01
2019-A00043-54 ( Other Identifier: ANSM Number (ID-RCB) )
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient could request investigator or Data Protection Officer an access to IPD according to French regulation (act No. 78-17 of 6 January 1978 on data processing, data files and individual liberties, amended by act No. 2004-801 of 6 August 2004) and he EU General Data Protection Regulation (GDPR) of 27 april 2016 applicable since 25 May 2018.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Association Francaise pour la Recherche Thermale:
Spa treatment
Cognitive Behavioral Therapy
Internet delivered self-help program
Insomnia
Sleep restriction
stimulus control
crenotherapy
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders