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Chronic InsomniaNEXPERTSANTENCT02539862

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

A study testing cognitive behavioral therapy online and psychoeducation in people with Chronic Insomnia, run by University Hospital, Montpellier.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Chronic Insomnia
What is being tested?
cognitive behavioral therapy online and psychoeducation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
No sites listed yet
Study dates
9 Jul 2015to May 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

About this study

Official title: 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).

Read the 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.

Being tested
cognitive behavioral therapy online, psychoeducation
Keywords
Insomnia, behavioral and cognitive therapies
Medical subject headings
Sleep Initiation and Maintenance Disorders, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cognitive behavioral therapy onlineOther

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

  • psychoeducationOther

    the psychoeducation is delivered by a doctor

Study groups in NCT02539862
Study groupRoleWhat they receive
cognitive behavioral therapy onlineExperimentalpatients receive cognitive behavioral therapy via an online program
Receives: Other: cognitive behavioral therapy online
no cognitive behavioral therapy onlineOtherpatients receive psychoeducation by a doctor
Receives: Other: psychoeducation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 100 days

Secondary outcomes (7)

  1. sleep efficiency

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

    Measured: 100 days

  2. Sleep latency

    collection of data with actiwatch2 sensor

    Measured: 100 days

  3. duration of night wakings

    collection of data with actiwatch2 sensor

    Measured: 100 days

  4. total sleep time

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

    Measured: 100 days

  5. Sleep quality

    sleepiness score assessed by a specific questionnaire

    Measured: 100 days

  6. quantity of hypnotic treatment

    number of hypnotic which will be consume by patient

    Measured: 100 days

  7. adherence to CBT-I program online

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

    Measured: 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2015 (estimated)
  2. Study start9 Jul 2015
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539862
Sponsor's protocol ID
9454
Acronym
NEXPERTSANTE
Status last verified
May 2018
First submitted
24 Jul 2015
Last updated
15 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Leger D, Levy E, Paillard M. The direct costs of insomnia in France. Sleep. 1999 May 1;22 Suppl 2:S394-401.

    PubMed 10394613

  • Leigh JP. Employee and job attributes as predictors of absenteeism in a national sample of workers: the importance of health and dangerous working conditions. Soc Sci Med. 1991;33(2):127-37. doi: 10.1016/0277-9536(91)90173-a.

    PubMed 1887276

  • Morin CM, Culbert JP, Schwartz SM. Nonpharmacological interventions for insomnia: a meta-analysis of treatment efficacy. Am J Psychiatry. 1994 Aug;151(8):1172-80. doi: 10.1176/ajp.151.8.1172.

    PubMed 8037252

  • Murtagh DR, Greenwood KM. Identifying effective psychological treatments for insomnia: a meta-analysis. J Consult Clin Psychol. 1995 Feb;63(1):79-89. doi: 10.1037//0022-006x.63.1.79.

    PubMed 7896994

  • Gagnon C, Belanger L, Ivers H, Morin CM. Validation of the Insomnia Severity Index in primary care. J Am Board Fam Med. 2013 Nov-Dec;26(6):701-10. doi: 10.3122/jabfm.2013.06.130064.

    PubMed 24204066

  • Smith MT, Perlis ML, Park A, Smith MS, Pennington J, Giles DE, Buysse DJ. Comparative meta-analysis of pharmacotherapy and behavior therapy for persistent insomnia. Am J Psychiatry. 2002 Jan;159(1):5-11. doi: 10.1176/appi.ajp.159.1.5.

    PubMed 11772681

  • Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.

    PubMed 16448292

  • I. Okajima, Y. Komada, and Y. Inoue, A meta-analysis on the treatment effectiveness of cognitive behavioral therapy for primary insomnia. Sleep and Biological Rhythms, 2011. 9(1): p. 24-34.

  • Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872.

    PubMed 22654196

  • Ritterband LM, Thorndike FP, Gonder-Frederick LA, Magee JC, Bailey ET, Saylor DK, Morin CM. Efficacy of an Internet-based behavioral intervention for adults with insomnia. Arch Gen Psychiatry. 2009 Jul;66(7):692-8. doi: 10.1001/archgenpsychiatry.2009.66.

    PubMed 19581560

  • Morin CM, Bootzin RR, Buysse DJ, Edinger JD, Espie CA, Lichstein KL. Psychological and behavioral treatment of insomnia:update of the recent evidence (1998-2004). Sleep. 2006 Nov;29(11):1398-414. doi: 10.1093/sleep/29.11.1398.

    PubMed 17162986

  • NIH State-of-the-Science Conference Statement on manifestations and management of chronic insomnia in adults. NIH Consens State Sci Statements. 2005 Jun 13-15;22(2):1-30.

    PubMed 17308547

  • Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.

    PubMed 18853708

  • Thorndike FP, Ritterband LM, Gonder-Frederick LA, Lord HR, Ingersoll KS, Morin CM. A randomized controlled trial of an internet intervention for adults with insomnia: effects on comorbid psychological and fatigue symptoms. J Clin Psychol. 2013 Oct;69(10):1078-93. doi: 10.1002/jclp.22032. Epub 2013 Aug 28.

    PubMed 24014057

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246

Questions about this trial

What is this clinical trial studying?

A study testing cognitive behavioral therapy online and psychoeducation in people with Chronic Insomnia, run by University Hospital, Montpellier.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

insomnia severity measured (time frame: 100 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539862, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.

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