Optimization of Insomnia Treatment in Primary Care

April 5, 2022 updated by: Charles M. Morin, Laval University

Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Quebec City, Quebec, Canada, G1K 0A6
        • Recruiting
        • Laval University
        • Contact:
        • Principal Investigator:
          • Charles M Morin, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment as usual
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
Drug: Hypnotics
Medication used 1 to 7 nights/week for 6 to 8 weeks.
Experimental: Online cognitive behavior therapy
Online CBT- Internet self-help program for insomnia with 6 cores
Behavioral: Online CBT
Internet self-help program for insomnia with 6 cores.
Experimental: Treatment as usual + Online CBT
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
Drug: Hypnotics
Medication used 1 to 7 nights/week for 6 to 8 weeks.
Behavioral: Online CBT
Internet self-help program for insomnia with 6 cores.
Experimental: Medication
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
Drug: Hypnotics
Medication used 1 to 7 nights/week for 6 to 8 weeks.
Experimental: In-person cognitive behavior therapy
Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Behavioral: Face-to-face CBT
Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
No Intervention: No additional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of insomnia
Time Frame: Post-1 (after 6-week treatment phase 1)
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Post-1 (after 6-week treatment phase 1)
Remission of insomnia
Time Frame: Post-2 (after 6-week treatment phase 2)
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Post-2 (after 6-week treatment phase 2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total sleep time from sleep diary
Time Frame: Post-1 (after 6-week treatment phase 1)
Mean total sleep time per night in minutes from sleep diary
Post-1 (after 6-week treatment phase 1)
Total sleep time from sleep diary
Time Frame: Post-2 (after 6-week treatment phase 2)
Mean total sleep time per night in minutes from sleep diary
Post-2 (after 6-week treatment phase 2)
Total wake time from sleep diary
Time Frame: Post-1 (after 6-week treatment phase 1)
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
Post-1 (after 6-week treatment phase 1)
Total wake time from sleep diary
Time Frame: Post-2 (after 6-week treatment phase 2)
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
Post-2 (after 6-week treatment phase 2)
Sleep efficiency from sleep diary
Time Frame: Post-1 (after 6-week treatment phase 1)
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
Post-1 (after 6-week treatment phase 1)
Sleep efficiency from sleep diary
Time Frame: Post-2 (after 6-week treatment phase 2)
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
Post-2 (after 6-week treatment phase 2)
Total sleep time from actigraphy
Time Frame: Post-1 (after 6-week treatment phase 1)
Mean total sleep time per night in minutes from actigraphy
Post-1 (after 6-week treatment phase 1)
Total sleep time from actigraphy
Time Frame: Post-2 (after 6-week treatment phase 2)
Mean total sleep time per night in minutes from actigraphy
Post-2 (after 6-week treatment phase 2)
Total wake time from actigraphy
Time Frame: Post-1 (after 6-week treatment phase 1)
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy
Post-1 (after 6-week treatment phase 1)
Total wake time from actigraphy
Time Frame: Post-2 (after 6-week treatment phase 2)
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy
Post-2 (after 6-week treatment phase 2)
Sleep efficiency from actigraphy
Time Frame: Post-1 (after 6-week treatment phase 1)
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Post-1 (after 6-week treatment phase 1)
Sleep efficiency from actigraphy
Time Frame: Post-2 (after 6-week treatment phase 2)
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Post-2 (after 6-week treatment phase 2)
Fatigue
Time Frame: Post-1 (after 6-week treatment phase 1)
Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue)
Post-1 (after 6-week treatment phase 1)
Fatigue
Time Frame: Post-2 (after 6-week treatment phase 2)
Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue)
Post-2 (after 6-week treatment phase 2)
Depression
Time Frame: Post-1 (after 6-week treatment phase 1)
Patient Health Questionnaire (PHQ-9)
Post-1 (after 6-week treatment phase 1)
Depression
Time Frame: Post-2 (after 6-week treatment phase 2)
Patient Health Questionnaire (PHQ-9)
Post-2 (after 6-week treatment phase 2)
Anxiety
Time Frame: Post-1 (after 6-week treatment phase 1)
Generalized Anxiety Disorder 7-item (GAD-7)
Post-1 (after 6-week treatment phase 1)
Anxiety
Time Frame: Post-2 (after 6-week treatment phase 2)
Generalized Anxiety Disorder 7-item (GAD-7)
Post-2 (after 6-week treatment phase 2)
Disability
Time Frame: Post-1 (after 6-week treatment phase 1)
Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability)
Post-1 (after 6-week treatment phase 1)
Disability
Time Frame: Post-2 (after 6-week treatment phase 2)
Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability)
Post-2 (after 6-week treatment phase 2)
Medication use
Time Frame: Post-1 (after 6-week treatment phase 1)
Frequency of use (number of nights/week)
Post-1 (after 6-week treatment phase 1)
Medication use
Time Frame: Post-2 (after 6-week treatment phase 2)
Frequency of use (number of nights/week)
Post-2 (after 6-week treatment phase 2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Charles Morin, PhD, Université Laval Centre d'étude des troubles du sommeil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIHR0083000212

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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