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Completed

NCT Number: NCT02539862

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).

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral therapy online

Other

The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password

Psychoeducation

Other

the psychoeducation is delivered by a doctor

Primary outcomes

  1. 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).

Secondary outcomes

  1. sleep efficiency

    Time frame: 100 days

    duration of of sleep time compared to the time window passed to bed

  2. Sleep latency

    Time frame: 100 days

    collection of data with actiwatch2 sensor

  3. duration of night wakings

    Time frame: 100 days

    collection of data with actiwatch2 sensor

  4. total sleep time

    Time frame: 100 days

    The total sleep time measured by sleep diary and actometer (Actiwatch 2 Sleep).

  5. Sleep quality

    Time frame: 100 days

    sleepiness score assessed by a specific questionnaire

  6. quantity of hypnotic treatment

    Time frame: 100 days

    number of hypnotic which will be consume by patient

  7. adherence to CBT-I program online

    Time frame: 100 days

    the number of steps performed in the program, and the weekly frequency of connection.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Official study title

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

Acronym: NEXPERTSANTE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2015
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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