CompletedNot Applicable

Self Help Program for Hypnotics Withdrawal in Insomniac Patients

France62 participantsStarted 2016-10-04

Plain-language 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).

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient complaining of persistent insomnia without co-morbidities (DSM-5) and treated for at least 3 months with monotherapy of: * Zopiclone or Zolpidem with usual doses (3.5 doses per week at least to a maximum of 14 per week) OR Intermediate half-life benzodiazepines included in the appendix 1 list with usual doses (3.5 doses per week at least to a maximum of 14 per week) * Motivated to stop hypnotic treatment (score \>5 on a 1 to 10 degrees VAS) * 18 to 75 years old, * Man or woman, * Having an internet connection, * Affiliated to a national health service, * Having given written informed consent to participate in the trial. Exclusion Criteria: * Patient with 2 psychotropic drugs or more taken daily for insomnia complaints (antidepressant, anxiolytic and antihistamine treatments will be allowed if they are prescribed for a stabilized mood and/or anxiety disorder). * Patient not believing in short-term simple self-help program * Insomnia with comorbidities other than a stabilized mood and/or anxiety disorder * Night and shift-workers, * Current Psychiatric disorder : mood disorder (depression, bipolar disorder) with a BDI score \> 19, anxiety disorder, psychosis * All sleep disorders other than persistent insomnia (clinical interview), * Progressive neurological diseases that include restless legs syndrome, * Unstable Cardiovascular disease, * Unstable respiratory or endocrinological diseases (clinical interview), * Drug addiction, alcohol addiction…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Urinary hypnotics screening assessed during Visit 2

Timeframe: 7 weeks after randomization visit

Trial details

NCT IDNCT02720458

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-10-25

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