NCT00042146

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.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

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

December 1, 2001

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 26, 2002

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

First QC Date

July 24, 2002

Last Update Submit

May 17, 2013

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

InsomniaSleep DisordersSleep Deprivation

Interventions

Cognitive-behavior therapyBEHAVIORAL
zolpidemDRUG

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Major medical or psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University

Québec, Quebec, G1K 7P4, Canada

Location

Related Publications (4)

  • 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.

    PMID: 30871960DERIVED

  • 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.

    PMID: 28364426DERIVED

  • 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.

    PMID: 27658218DERIVED

  • 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.

    PMID: 19454639DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersSleep Wake DisordersSleep Deprivation

Interventions

Cognitive Behavioral TherapyZolpidem

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2002

First Posted

July 26, 2002

Study Start

December 1, 2001

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations

CA(1)