Self Help Program for Hypnotics Withdrawal in Insomniac Patients

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Insomnia
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT02720458
Study type	Interventional
Source	University Hospital, Bordeaux
Contact
Status	Completed
Phase	N/A
Start date	October 4, 2016
Completion date	November 25, 2019

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT05963542` - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia	N/A
Completed	`NCT06339853` - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia	N/A
Recruiting	`NCT04069247` - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia	N/A
Completed	`NCT04493593` - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility	N/A
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Recruiting	`NCT06278077` - Neurexan - a Clinical Trial in Short-Term Insomnia Patients	Phase 2
Completed	`NCT04661306` - The Better Sleep for Supporters With Insomnia Study	N/A
Recruiting	`NCT06207279` - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting	`NCT06006299` - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT04035200` - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation	Phase 2
Active, not recruiting	`NCT05027438` - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention	N/A
Recruiting	`NCT06053840` - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia	Phase 4
Not yet recruiting	`NCT06348082` - Project Women's Insomnia Sleep Health Equity Study (WISHES)	N/A
Not yet recruiting	`NCT06363799` - Osteopathic Protocol for Insomnia in College Students	N/A
Not yet recruiting	`NCT05991492` - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application	N/A
Not yet recruiting	`NCT06025968` - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Self Help Program for Hypnotics Withdrawal in Insomniac Patients — PROPERSOM

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms