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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03633305
Other study ID # CIHR0083000212
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2018
Est. completion date December 2023

Study information

Verified date April 2022
Source Laval University
Contact Manon Lamy
Phone 418-656-2131
Email manon.lamy@psy.ulaval.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
Face-to-face CBT
Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.

Locations

Country Name City State
Canada Laval University Quebec City Quebec

Sponsors (2)

Lead Sponsor Collaborator
Laval University Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Remission of insomnia Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10) Post-1 (after 6-week treatment phase 1)
Primary 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 Total sleep time from sleep diary Mean total sleep time per night in minutes from sleep diary Post-1 (after 6-week treatment phase 1)
Secondary Total sleep time from sleep diary Mean total sleep time per night in minutes from sleep diary Post-2 (after 6-week treatment phase 2)
Secondary Total wake time from sleep diary 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)
Secondary Total wake time from sleep diary 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)
Secondary Sleep efficiency from sleep diary 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)
Secondary Sleep efficiency from sleep diary 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)
Secondary Total sleep time from actigraphy Mean total sleep time per night in minutes from actigraphy Post-1 (after 6-week treatment phase 1)
Secondary Total sleep time from actigraphy Mean total sleep time per night in minutes from actigraphy Post-2 (after 6-week treatment phase 2)
Secondary Total wake time from actigraphy 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)
Secondary Total wake time from actigraphy 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)
Secondary Sleep efficiency from actigraphy 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)
Secondary Sleep efficiency from actigraphy 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)
Secondary Fatigue 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)
Secondary Fatigue 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)
Secondary Depression Patient Health Questionnaire (PHQ-9) Post-1 (after 6-week treatment phase 1)
Secondary Depression Patient Health Questionnaire (PHQ-9) Post-2 (after 6-week treatment phase 2)
Secondary Anxiety Generalized Anxiety Disorder 7-item (GAD-7) Post-1 (after 6-week treatment phase 1)
Secondary Anxiety Generalized Anxiety Disorder 7-item (GAD-7) Post-2 (after 6-week treatment phase 2)
Secondary Disability 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)
Secondary Disability 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)
Secondary Medication use Frequency of use (number of nights/week) Post-1 (after 6-week treatment phase 1)
Secondary Medication use Frequency of use (number of nights/week) Post-2 (after 6-week treatment phase 2)
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