Optimization of Insomnia Treatment in Primary Care

Insomnia Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03633305
• Other study ID #: CIHR0083000212
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Insomnia Disorder
• Sleep Initiation and Maintenance Disorders

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)