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

Chronic Insomnia Clinical Trial

— NEXPERTSANTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539862
• Other study ID #: 9454
• Status: Completed
• Phase: N/A
• Start date: July 9, 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

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
• psychoeducation
the psychoeducation is delivered by a doctor

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut National de la Santé Et de la Recherche Médicale, France

References & Publications (20)

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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. — View Citation

Gagnon C, Bélanger 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. — View Citation

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.

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. Review. — View Citation

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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. Review. — View Citation

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. — View Citation

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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. Review. — View Citation

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. Erratum in: Arch Gen Psychiatry. 2010 Mar;67(3):311. — View Citation

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. — View Citation

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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. — View Citation

* Note: There are 20 references in all — Click here to view all references

Outcome

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