Chronic Insomnia
Conditions
Keywords
Insomnia, behavioral and cognitive therapies
Brief summary
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).
Detailed description
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.
Interventions
OTHERcognitive behavioral therapy online
The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password
OTHERpsychoeducation
the psychoeducation is delivered by a doctor
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age between 20 and 65 * disorder diagnosis of chronic insomnia (according to Diagnostic and Statistical Manual-5) * sleep efficiency \<80% * Index severe insomnia: ISI\> 14/28 * have a computer at home * Practicing internet regularly in everyday life * have a personal email address
Exclusion criteria
* Clinically suffer from insomnia comorbid linked to other sleep disorders * Presenting an unbalanced psychiatric disorder * Have Score Beck Depression Inventory (BDI-II) \>29 * Have neurological disorders * Have severe medical conditions that can affect the quality of sleep * Have Hypnotic, Anxiolytic, antidepressants Treatment \> 2 * Have antipsychotics, opioids, anticonvulsants, anti-parkinson treatment * Having a disorder of substance use (alcohol, drugs) in the last 6 months * Having undertaken a meridian trance journey (± 3H) in the preceding month or during the study period * Already be treated with CBT-I
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insomnia severity measured | 100 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep latency | 100 days | collection of data with actiwatch2 sensor |
| duration of night wakings | 100 days | collection of data with actiwatch2 sensor |
| total sleep time | 100 days | The total sleep time measured by sleep diary and actometer (Actiwatch 2 Sleep). |
| sleep efficiency | 100 days | duration of of sleep time compared to the time window passed to bed |
| quantity of hypnotic treatment | 100 days | number of hypnotic which will be consume by patient |
| adherence to CBT-I program online | 100 days | the number of steps performed in the program, and the weekly frequency of connection. |
| Sleep quality | 100 days | sleepiness score assessed by a specific questionnaire |
Outcome results
None listed