An interventional study of cognitive behavioral therapy online and psychoeducation in Chronic Insomnia, sponsored by University Hospital, Montpellier. Completed. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-05-15.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Supportive care
The purpose of this study is to evaluate the effectiveness of the management of chronic primary insomnia patients by a computer program guidance of behavioral and cognitive therapies for insomnia (BCT-I).
Chronic insomnia is a common sleep disorder (prevalence = 10%) and a risk identified on the physical and mental health. Currently, the treatment involves the prescription of drug treatments by general practitioners, which may be unsuitable for the medium term. It is better to turn to Behavioral and Cognitive Therapies for Insomnia (BCT-I) in the case of primary chronic insomnia. The objective of this study is to evaluate the effectiveness of a computer program guidance BCT-I in patients with chronic primary insomnia. This biomedical research psychotherapeutic assessment will be randomized, controlled versus psychoeducation and conducted in 46 patients with chronic primary insomnia (defined according to Diagnostic and Statistical Manual-5) for which a supported by BCT-I is indicated.
The 46 patients will be randomized into two groups. The subjects in Group 1 will be supported by BCT-I online. And the subjects in group 2 will receive psychoeducation. All patients will be followed by the research team for three months, during which 3 visits (V0 = pre-selection; V1 = visit of randomization and start of the program; V2 = 3 months follow-up visit and end of the study) will be performed in the University Hospital Sleep Disorder Unit of Montpellier. Patients in Group 1 will conduct BCT-I online at home therapy. Patients in group 2 will receive a structured 45-minute session information insomnia (psychoeducation = work performed daily by clinicians in charge of insomnia problems) to the visit 1. All patients in the study will be equipped 2 sensors for the registration of sleep data.
The primary endpoint will be based on the severity of insomnia measured by the ISI after the last online psychotherapy session (3 months) between the 2 groups of patients (BCT-I online and without treatment - psychoeducation ). The analyse efficacity to be conducted by intention to treat.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 593 are open to participants now.
This study's enrollment of 46 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients receive cognitive behavioral therapy via an online program
Other: cognitive behavioral therapy online
patients receive psychoeducation by a doctor
Other: psychoeducation
The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password
the psychoeducation is delivered by a doctor
insomnia severity measured
The primary endpoint will focus on the severity of insomnia measured by the Index severe insomnia (ISI) at the end of the last session of CBT (3 months) between the 2 groups of patients (CBT-I online and psychoeducation).
Time frame: 100 days
sleep efficiency
duration of of sleep time compared to the time window passed to bed
Time frame: 100 days
Sleep latency
collection of data with actiwatch2 sensor
Time frame: 100 days
duration of night wakings
collection of data with actiwatch2 sensor
Time frame: 100 days
total sleep time
The total sleep time measured by sleep diary and actometer (Actiwatch 2 Sleep).
Time frame: 100 days
Sleep quality
sleepiness score assessed by a specific questionnaire
Time frame: 100 days
quantity of hypnotic treatment
number of hypnotic which will be consume by patient
Time frame: 100 days
adherence to CBT-I program online
the number of steps performed in the program, and the weekly frequency of connection.
Time frame: 100 days
No study locations are listed for this record.
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sleep Initiation and Maintenance Disorders→
University Hospital, Montpellier