Self Help Program for Hypnotics Withdrawal in Insomniac Patients
Condition: Insomnia
Study type: Interventional

Summary: 
      Persistent insomnia has a high prevalence in French general population affecting between 15.8
      % and 19 % of adults. In France, the disease is mainly managed by general practitioners (GP)
      who usually proposed intermediate half-life benzodiazepines and Z-drugs in first-line
      treatment. French Health authorities recommend restricting the consumption of both hypnotics
      to no more than 4 weeks, considering their potential adverse effects (memory impairment,
      altered sleep physiology, motor-vehicle crash), and the risk of tolerance and dependence.
      However, it appears that a majority of patients become chronic users. Therefore,
      discontinuation of benzodiazepines/Z-drugs is recommended, but it may appear as a challenge
      due to withdrawal symptoms and psychological factors (anticipatory anxiety, fear of rebound
      insomnia).

      Numerous studies have shown that programs based on Cognitive-Behavioural Therapy (CBT)
      principles improve sleep and daily life quality leading to hypnotic taper and maintain of
      hypnotic abstinence in insomniac patients. Cognitive-Behavioural Therapy (CBT) is based on 4
      components: sleep restriction, stimulus control, cognitive therapy and sleep hygiene
      education. This therapy is dependent on a therapeutic alliance between practitioner and
      patient. Unfortunately, there are an insufficient number of trained CBT experts especially in
      France.

      The implementation of an internet-delivered self-help program based on time-in-bed
      restriction and stimulus control may be an issue within the context of general practice.

      Online programs based on CBT principles have been proved to be effective in improving the
      sleep and daytime functioning in this population, but the studies were realized in small
      patients groups.

      Investigators hypothesis is that a simple and internet-delivered short-term program based on
      sleep restriction therapy and stimulus control (following to a GP consultation) may
      facilitate hypnotics discontinuation (benzodiazepines/Z-drugs) in patient with insomnia
      disorder still reporting sleep complaints in comparison with a tapering alone (no access to
      the self-help program).
    


Intervention name(s): Standardized gradual hypnotic taper; Short-term simple self-help program
Intervention type(s): Other; Behavioral
Intervention description(s): The gradual hypnotic taper is standardized and is adjusted depending on the hypnotic treatment and the initial weekly dose. The practitioner will give to the patient a calendar for the taper period with the specific dose for each day (name of hypnotic, quantity and dose of pills).; The short-term simple self-help program consists in:
Restriction of time in bed
Stimulus control instructions
The restriction of time in bed would be delivered by an e-health tool (web site). The patient will have to connect to the web site with an individual connexion password. He will connect every day to complete an on-line sleep diary during the period of the simple short-term behavioural program (5 weeks). After this period, patients will have the choice to continue connecting to the website and using the program or to stop using the program.
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Hypnotics withdrawal in insomniac patients; Cognitive-Behavioural Therapy (CBT); Internet-delivered self-help program; Sleep restriction; Stimulus control; Half-life benzodiazepine; Z-drug