Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia (NEXPERTSANTE)

May 9, 2018 updated by: University Hospital, Montpellier

Pilot Study Evaluating the Efficacy of the Management of an Online Program of Cognitive Behavioral Therapy for Primary Insomnia

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: cognitive behavioral therapy online
patients receive cognitive behavioral therapy via an online program
Other: cognitive behavioral therapy online
The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password
Other: no cognitive behavioral therapy online
patients receive psychoeducation by a doctor
Other: psychoeducation
the psychoeducation is delivered by a doctor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insomnia severity measured
Time Frame: 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).
100 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep efficiency
Time Frame: 100 days
duration of of sleep time compared to the time window passed to bed
100 days
Sleep latency
Time Frame: 100 days
collection of data with actiwatch2 sensor
100 days
duration of night wakings
Time Frame: 100 days
collection of data with actiwatch2 sensor
100 days
total sleep time
Time Frame: 100 days
The total sleep time measured by sleep diary and actometer (Actiwatch 2 Sleep).
100 days
Sleep quality
Time Frame: 100 days
sleepiness score assessed by a specific questionnaire
100 days
quantity of hypnotic treatment
Time Frame: 100 days
number of hypnotic which will be consume by patient
100 days
adherence to CBT-I program online
Time Frame: 100 days
the number of steps performed in the program, and the weekly frequency of connection.
100 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Dauvilliers Yves, Unit of sleep disorders

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9454

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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