Back to resultsOptimization of Insomnia Treatment in Primary Care
Primary Purpose
Insomnia Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Hypnotics
Online CBT
Face-to-face CBT
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia Disorder focused on measuring Insomnia, Pragmatic Clinical Trial, Drug Therapy, Cognitive Behavior Therapy, Primary Care
Eligibility Criteria
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
Sites / Locations
- Laval UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
No Intervention
Arm Label
Treatment as usual
Online cognitive behavior therapy
Treatment as usual + Online CBT
Medication
In-person cognitive behavior therapy
No additional treatment
Arm Description
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
Online CBT- Internet self-help program for insomnia with 6 cores
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Outcomes
Primary Outcome Measures
Remission of insomnia
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Remission of insomnia
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Secondary Outcome Measures
Total sleep time from sleep diary
Mean total sleep time per night in minutes from sleep diary
Total sleep time from sleep diary
Mean total sleep time per night in minutes from sleep diary
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
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
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
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
Total sleep time from actigraphy
Mean total sleep time per night in minutes from actigraphy
Total sleep time from actigraphy
Mean total sleep time per night in minutes from actigraphy
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
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
Sleep efficiency from actigraphy
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Sleep efficiency from actigraphy
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
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)
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)
Depression
Patient Health Questionnaire (PHQ-9)
Depression
Patient Health Questionnaire (PHQ-9)
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7)
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7)
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)
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)
Medication use
Frequency of use (number of nights/week)
Medication use
Frequency of use (number of nights/week)
Full Information
NCT ID
NCT03633305
First Posted
July 17, 2018
Last Updated
April 5, 2022
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
1. Study Identification
Unique Protocol Identification Number
NCT03633305
Brief Title
Optimization of Insomnia Treatment in Primary Care
Official Title
Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Disorder
Keywords
Insomnia, Pragmatic Clinical Trial, Drug Therapy, Cognitive Behavior Therapy, Primary Care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The study involves two treatment phases of six to eight weeks. In the first phase, participants choose medication (treatment as usual), online cognitive behavior therapy, or online cognitive behavior therapy combined with medication. Participants enter a second treatment phase if they still experience insomnia after the first treatment. The treatment arms for the second phase are medication, in-person cognitive-behavior therapy, or no additional treatment.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
Arm Title
Online cognitive behavior therapy
Arm Type
Experimental
Arm Description
Online CBT- Internet self-help program for insomnia with 6 cores
Arm Title
Treatment as usual + Online CBT
Arm Type
Experimental
Arm Description
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
Arm Title
Medication
Arm Type
Experimental
Arm Description
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
Arm Title
In-person cognitive behavior therapy
Arm Type
Experimental
Arm Description
Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Arm Title
No additional treatment
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Hypnotics
Intervention Description
Medication used 1 to 7 nights/week for 6 to 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Online CBT
Intervention Description
Internet self-help program for insomnia with 6 cores.
Intervention Type
Behavioral
Intervention Name(s)
Face-to-face CBT
Intervention Description
Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Primary Outcome Measure Information:
Title
Remission of insomnia
Description
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Remission of insomnia
Description
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Time Frame
Post-2 (after 6-week treatment phase 2)
Secondary Outcome Measure Information:
Title
Total sleep time from sleep diary
Description
Mean total sleep time per night in minutes from sleep diary
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Total sleep time from sleep diary
Description
Mean total sleep time per night in minutes from sleep diary
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Total wake time from sleep diary
Description
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Total wake time from sleep diary
Description
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Sleep efficiency from sleep diary
Description
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Sleep efficiency from sleep diary
Description
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Total sleep time from actigraphy
Description
Mean total sleep time per night in minutes from actigraphy
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Total sleep time from actigraphy
Description
Mean total sleep time per night in minutes from actigraphy
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Total wake time from actigraphy
Description
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Total wake time from actigraphy
Description
Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Sleep efficiency from actigraphy
Description
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Sleep efficiency from actigraphy
Description
Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Fatigue
Description
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)
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Fatigue
Description
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)
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Depression
Description
Patient Health Questionnaire (PHQ-9)
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Depression
Description
Patient Health Questionnaire (PHQ-9)
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Anxiety
Description
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Anxiety
Description
Generalized Anxiety Disorder 7-item (GAD-7)
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Disability
Description
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)
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Disability
Description
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)
Time Frame
Post-2 (after 6-week treatment phase 2)
Title
Medication use
Description
Frequency of use (number of nights/week)
Time Frame
Post-1 (after 6-week treatment phase 1)
Title
Medication use
Description
Frequency of use (number of nights/week)
Time Frame
Post-2 (after 6-week treatment phase 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manon Lamy
Phone
418-656-2131
Ext
12467
Email
manon.lamy@psy.ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Morin, PhD
Organizational Affiliation
Université Laval Centre d'étude des troubles du sommeil
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1K 0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manon Lamy
Phone
418 656-2131
Ext
12467
Email
manon.lamy@psy.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Charles M Morin, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Optimization of Insomnia Treatment in Primary Care
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