Clinical trial NCT02720458: Self Help Program for Hypnotics Withdrawal in Insomniac Patients
Official title: Self-help Program for Hypnotics Withdrawal in Chronic Insomniac Patients: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Hypnotics withdrawal in insomniac patients
Cognitive-Behavioural Therapy (CBT)
Internet-delivered self-help program
Sleep restriction
Stimulus control
Half-life benzodiazepine
Z-drug
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Urinary hypnotics screening assessed during Visit 2
timeFrame: 7 weeks after randomization visit
Secondary outcomes:
measure: Urinary hypnotics screening assessed during Visit 3
timeFrame: 17 weeks after randomization visit
measure: Total sleep time obtained by actimetry
timeFrame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
measure: Sleep efficiency obtained by actimetry
timeFrame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
measure: Wake after sleep onset obtained by actimetry
timeFrame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
measure: Sleep latency obtained by actimetry
timeFrame: During 10 nights before Visit 2 wich is scheduled 7 weeks after randomization visit
measure: Total sleep time obtained by sleep diary
timeFrame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
measure: Sleep efficiency obtained by sleep diary
timeFrame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
measure: Wake after sleep onset obtained by sleep diary
timeFrame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
measure: Sleep latency obtained by sleep diary
timeFrame: Every night between Pre-Inclusion visit (Visit 0) and Week 5 after Visit 1
measure: Insomnia Severity Scale (ISI) score
timeFrame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
measure: Leeds Sleep Evaluation Questionnaire (LSEQ) score
timeFrame: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
measure: Beck Depression Inventory Second Edition (BDI-II) score
timeFrame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
measure: Beck anxiety Inventory (BAI) score
timeFrame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
measure: Short-Form SF-36 Health Survey score
timeFrame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) ,7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
measure: Benzodiazepine Withdrawal Symptoms Questionnaire (BWSQ) score
timeFrame: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
measure: Self-efficiency visual analog scale score
timeFrame: Pre-inclusion visit (between 21 to 10 days before randomization), randomization visit (Visit 1) and 7 weeks after randomization (Visit 2)
measure: Reasons for non-compliance obtained during patient interview
timeFrame: 7 weeks after randomization (Visit 2) and 17 weeks after randomization (Visit 3)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Garches
country: France
facility: APHP Hôpital Raymond Poincaré
city: Lille
country: France
facility: CHRU de Lille
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: AP-HP Hôpital Pitié-Salpétrière
city: Paris
country: France
facility: APHP Hôtel-Dieu de Paris
Study officials:
affiliation: USMR - CHU de Bordeaux
name: Antoine BENARD, MD-PhD
role: STUDY_CHAIR
References: