Optimization of Insomnia Treatment in Primary Care
Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
1 other identifier
interventional
300
1 country
1
Brief Summary
The primary objective of this pragmatic clinical trial is to evaluate the efficacy, feasibility, and adaptability of pharmacological and non-pharmacological treatments for insomnia disorder, delivered in primary care clinics. The second objective is to evaluate the efficacy of a sequential (stepped care) approach for persistent insomnia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 16, 2018
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 6, 2022
April 1, 2022
5.3 years
July 17, 2018
April 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Remission of insomnia
Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)
Post-1 (after 6-week treatment phase 1)
Remission of insomnia
Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)
Post-2 (after 6-week treatment phase 2)
Secondary Outcomes (22)
Total sleep time from sleep diary
Post-1 (after 6-week treatment phase 1)
Total sleep time from sleep diary
Post-2 (after 6-week treatment phase 2)
Total wake time from sleep diary
Post-1 (after 6-week treatment phase 1)
Total wake time from sleep diary
Post-2 (after 6-week treatment phase 2)
Sleep efficiency from sleep diary
Post-1 (after 6-week treatment phase 1)
- +17 more secondary outcomes
Study Arms (6)
Treatment as usual
ACTIVE COMPARATORHypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
Online cognitive behavior therapy
EXPERIMENTALOnline CBT- Internet self-help program for insomnia with 6 cores
Treatment as usual + Online CBT
EXPERIMENTALHypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
Medication
EXPERIMENTALHypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
In-person cognitive behavior therapy
EXPERIMENTALFace-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
No additional treatment
NO INTERVENTIONInterventions
Medication used 1 to 7 nights/week for 6 to 8 weeks.
Internet self-help program for insomnia with 6 cores.
Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Eligibility Criteria
You may qualify if:
- Aged 18 years or over
- Meeting criteria for insomnia disorder
- Registered patient at one of the primary care clinics participating in the study
- Fluent in French
- Computer and internet access
You may not qualify if:
- Unstable or untreated psychiatric disorder
- Lifetime psychotic or bipolar disorder
- Current suicide risk
- Progressive or unstable medical disorder
- Untreated sleep disorder other than insomnia
- Use of medication altering sleep
- Irregular or atypical sleep-wake schedule
- Current or planned pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Laval University
Québec, Quebec, G1K 0A6, Canada
Related Publications (2)
Cheung JMY, Ritterband LM, Chen SJ, Ivers H, Morin CM. Stepped-Care Management of Insomnia: Treatment Choices Guided by a Patient Decision Aid in a Pragmatic Nonrandomized Clinical Trial Setting. J Sleep Res. 2025 Jun 26:e70127. doi: 10.1111/jsr.70127. Online ahead of print.
PMID: 40570832DERIVEDMorin CM, Chen SJ, Lemieux K, Ivers H, Cheung JMY, Lamy M, Ritterband L. Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial. Sleep Med. 2025 Aug;132:106551. doi: 10.1016/j.sleep.2025.106551. Epub 2025 May 3.
PMID: 40373353DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles Morin, PhD
Université Laval Centre d'étude des troubles du sommeil
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 17, 2018
First Posted
August 16, 2018
Study Start
September 1, 2018
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
April 6, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share