Self Help Program for Hypnotics Withdrawal in Insomniac Patients

NCT ID: NCT02720458

Last Updated: 2020-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-04
• Study Completion Date: 2019-11-25

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).

Conditions

Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standardized hypnotic taper and self-help program

Group Type: EXPERIMENTAL

Standardized gradual hypnotic taper

Intervention Type: OTHER

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).

Short-term simple self-help program

Intervention Type: BEHAVIORAL

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.

Standardized hypnotic taper only

Group Type: ACTIVE_COMPARATOR

Standardized gradual hypnotic taper

Intervention Type: OTHER

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).

Interventions

Standardized gradual hypnotic taper

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).

Intervention Type: OTHER

Short-term simple self-help program

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 Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antoine BENARD, MD-PhD

Role: STUDY_CHAIR

USMR - CHU de Bordeaux

Locations

CHU de Bordeaux

Bordeaux, , France

APHP Hôpital Raymond Poincaré

Garches, , France

CHRU de Lille

Lille, , France

CHU de Montpellier

Montpellier, , France

AP-HP Hôpital Pitié-Salpétrière

Paris, , France

APHP Hôtel-Dieu de Paris

Paris, , France

Countries

France

Other Identifiers

CHUBX 2014/35

Identifier Type: -

Identifier Source: org_study_id