Clinical trial NCT00042146: Behavioral and Pharmacological Treatment for Insomnia
Official title: Behavioral and Pharmacological Treatment for Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Insomnia
Sleep Disorders
Sleep Deprivation
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2002-07-26
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
Study officials:
References:
citation: Rochefort A, Jarrin DC, Belanger 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.
citation: 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):zsx002. doi: 10.1093/sleep/zsx002.
citation: Morin CM, Beaulieu-Bonneau S, Belanger L, Ivers H, Sanchez Ortuno M, Vallieres A, Savard J, Guay B, Merette 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.
citation: Morin CM, Vallieres A, Guay B, Ivers H, Savard J, Merette 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.