Optimization of Insomnia Treatment in Primary Care

Not Applicable

• Conditions: Insomnia Disorder
• Interventions: Drug: Hypnotics; Behavioral: Online CBT; Behavioral: Face-to-face CBT

• Registration Number: NCT03633305
• Lead Sponsor: Laval University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Study Start: 2018-09-01
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Hypnotics	Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
Online cognitive behavior therapy	Online CBT	Online CBT- Internet self-help program for insomnia with 6 cores
Treatment as usual + Online CBT	Hypnotics	Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores
Treatment as usual + Online CBT	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
Medication	Hypnotics	Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
In-person cognitive behavior therapy	Face-to-face CBT	Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.

Primary Outcome Measures

Name	Time	Method
Remission of insomnia	Post-2 (after 6-week treatment phase 2)	Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)

Secondary Outcome Measures

Name	Time	Method
Total sleep time from sleep diary	Post-2 (after 6-week treatment phase 2)	Mean total sleep time per night in minutes from sleep diary
Sleep efficiency from actigraphy	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
Depression	Post-2 (after 6-week treatment phase 2)	Patient Health Questionnaire (PHQ-9)
Anxiety	Post-2 (after 6-week treatment phase 2)	Generalized Anxiety Disorder 7-item (GAD-7)
Disability	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)
Medication use	Post-2 (after 6-week treatment phase 2)	Frequency of use (number of nights/week)
Total wake time from sleep diary	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
Sleep efficiency from sleep diary	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
Total sleep time from actigraphy	Post-2 (after 6-week treatment phase 2)	Mean total sleep time per night in minutes from actigraphy
Total wake time from actigraphy	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
Fatigue	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)

Trial Locations

Locations (1)

Laval University; 🇨🇦 Quebec City, Quebec, Canada