Behavioral and Pharmacological Treatment for Insomnia

• ClinicalTrials.gov Identifier: NCT00042146
• Recruitment Status: Completed
• First Posted: July 26, 2002
• Last Update Posted: May 21, 2013
• Sponsor: Laval University
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by: Laval University

Tracking Information

• First Submitted Date: July 24, 2002
• First Posted Date: July 26, 2002
• Last Update Posted Date: May 21, 2013
• Study Start Date: December 2001
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Change History: Complete list of historical versions of study NCT00042146 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Behavioral and Pharmacological Treatment for Insomnia
• Official Title: Behavioral and Pharmacological Treatment for Insomnia
• Brief Summary: This study will evaluate the long- and short-term effects of cognitive-behavior therapy (CBT), alone and in combination with zolpidem (Ambien®), for chronic insomnia.

Detailed Description

Insomnia is a prevalent health concern which is often associated with functional impairments, reduced quality of life, and increased health-care costs. The proposed study may provide useful information about optimal models for integrating behavioral and pharmacological therapies for the clinical management of insomnia.

Participants are randomly assigned to CBT or CBT plus medication. After the 6-week acute treatment phase, participants enter into a 6-month extended treatment phase. Of those treated with CBT alone initially, responders are randomized to extended CBT or no treatment. Of those receiving the combined CBT plus medication approach initially, responders are randomized to an extended treatment consisting of either CBT plus medication (used on an as needed schedule) or CBT alone (plus medication tapering). Outcome is evaluated across measures of sleep, clinical ratings, and several indices of daytime functioning. The measures are administered at baseline, at the end of the acute and extended treatment phases, and at 6, 12, and 24-month follow-up.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Sleep Initiation and Maintenance Disorders

Intervention

• Behavioral: Cognitive-behavior therapy
• Drug: zolpidem

• Study Arms: Not Provided

Publications *

• Rochefort A, Jarrin DC, Bélanger L, Ivers H, Morin CM. Insomnia treatment response as a function of objectively measured sleep duration. Sleep Med. 2019 Apr;56:135-144. doi: 10.1016/j.sleep.2019.01.016. Epub 2019 Jan 31.
• Beaulieu-Bonneau S, Ivers H, Guay B, Morin CM. Long-Term Maintenance of Therapeutic Gains Associated With Cognitive-Behavioral Therapy for Insomnia Delivered Alone or Combined With Zolpidem. Sleep. 2017 Mar 1;40(3). doi: 10.1093/sleep/zsx002.
• Morin CM, Beaulieu-Bonneau S, Bélanger L, Ivers H, Sánchez Ortuño M, Vallières A, Savard J, Guay B, Mérette C. Cognitive-behavior therapy singly and combined with medication for persistent insomnia: Impact on psychological and daytime functioning. Behav Res Ther. 2016 Dec;87:109-116. doi: 10.1016/j.brat.2016.09.002. Epub 2016 Sep 13.
• Morin CM, Vallières A, Guay B, Ivers H, Savard J, Mérette C, Bastien C, Baillargeon L. Cognitive behavioral therapy, singly and combined with medication, for persistent insomnia: a randomized controlled trial. JAMA. 2009 May 20;301(19):2005-15. doi: 10.1001/jama.2009.682.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: June 23, 2005): 160
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion criteria:

• Subjective complaint of difficulties initiating or maintaining sleep, accompanied by marked distress or daytime impairments due to insomnia
• Sleep difficulties present 3 nights or more per week and lasting for more than 6 months

Exclusion criteria:

• Major medical or psychiatric problems

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00042146
• Other Study ID Numbers: R01MH060413( U.S. NIH Grant/Contract ); R01MH060413 ( U.S. NIH Grant/Contract ); DATR A4-GPS
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: Laval University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Not Provided
• PRS Account: Laval University
• Verification Date: May 2013