NCT02539862

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 3, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

July 24, 2015

Last Update Submit

May 9, 2018

Conditions

Chronic Insomnia

Keywords

Insomniabehavioral and cognitive therapies

Outcome Measures

Primary Outcomes (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).

    100 days

Secondary Outcomes (7)

  • sleep efficiency

    100 days

  • Sleep latency

    100 days

  • duration of night wakings

    100 days

  • total sleep time

    100 days

  • Sleep quality

    100 days

  • +2 more secondary outcomes

Study Arms (2)

cognitive behavioral therapy online

EXPERIMENTAL

patients receive cognitive behavioral therapy via an online program

Other: cognitive behavioral therapy online

no cognitive behavioral therapy online

OTHER

patients receive psychoeducation by a doctor

Other: psychoeducation

Interventions

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

cognitive behavioral therapy online
psychoeducationOTHER

the psychoeducation is delivered by a doctor

no cognitive behavioral therapy online

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

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

    PMID: 10394613BACKGROUND

  • 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.

    PMID: 1887276BACKGROUND

  • 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.

    PMID: 8037252BACKGROUND

  • 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.

    PMID: 7896994BACKGROUND

  • 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.

    PMID: 24204066BACKGROUND

  • 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.

    PMID: 11772681BACKGROUND

  • 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.

    PMID: 16448292BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 22654196BACKGROUND

  • 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.

    PMID: 19581560BACKGROUND

  • 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.

    PMID: 17162986BACKGROUND

  • 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.

    PMID: 17308547BACKGROUND

  • 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.

    PMID: 18853708BACKGROUND

  • 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.

    PMID: 24014057BACKGROUND

  • 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.

    PMID: 11438246BACKGROUND

  • Chalder T, Berelowitz G, Pawlikowska T, Watts L, Wessely S, Wright D, Wallace EP. Development of a fatigue scale. J Psychosom Res. 1993;37(2):147-53. doi: 10.1016/0022-3999(93)90081-p.

    PMID: 8463991BACKGROUND

  • Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991 Dec;14(6):540-5. doi: 10.1093/sleep/14.6.540.

    PMID: 1798888BACKGROUND

  • Chevalier J, de Pouvourville G. Valuing EQ-5D using time trade-off in France. Eur J Health Econ. 2013 Feb;14(1):57-66. doi: 10.1007/s10198-011-0351-x. Epub 2011 Sep 21.

    PMID: 21935715BACKGROUND

  • Leger D, Morin CM, Uchiyama M, Hakimi Z, Cure S, Walsh JK. Chronic insomnia, quality-of-life, and utility scores: comparison with good sleepers in a cross-sectional international survey. Sleep Med. 2012 Jan;13(1):43-51. doi: 10.1016/j.sleep.2011.03.020. Epub 2011 Nov 16.

    PMID: 22093806BACKGROUND

  • Cartwright RD. Alcohol and NREM parasomnias: evidence versus opinions in the international classification of sleep disorders, 3rd edition. J Clin Sleep Med. 2014 Sep 15;10(9):1039-40. doi: 10.5664/jcsm.4050. No abstract available.

    PMID: 25221449BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersBehavior

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Dauvilliers Yves

    Unit of sleep disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

September 3, 2015

Study Start

July 9, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

May 15, 2018

Record last verified: 2018-05