Self Help Program for Hypnotics Withdrawal in Insomniac Patients (PROPERSOM)

University Hospital of Bordeaux

Status

Completed

Conditions

Insomnia

Treatments

Behavioral: Short-term simple self-help program

Other: Standardized gradual hypnotic taper

Study type

Interventional

Funder types

Other

Identifiers

NCT02720458

CHUBX 2014/35

Details and patient eligibility

About

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).

Enrollment

62 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 during the previous 6 months (clinical interview),
Having undertaken trans-meridian travel (± 3H) in the previous 1 month
Pregnant or lactating woman,
Current participation in psychotherapy.