Optimization of Insomnia Treatment in Primary Care

Laval University300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Insomnia Disorder

Interventions

HypnoticsDRUG

Medication used 1 to 7 nights/week for 6 to 8 weeks.

Online CBTBEHAVIORAL

Internet self-help program for insomnia with 6 cores.

Face-to-face CBTBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Laval University

Québec, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

Remission of insomnia

Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)

Time frame: Post-1 (after 6-week treatment phase 1)

Remission of insomnia

Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)

Time frame: Post-2 (after 6-week treatment phase 2)

Secondary Outcomes

Total sleep time from sleep diary

Mean total sleep time per night in minutes from sleep diary

Time frame: Post-1 (after 6-week treatment phase 1)

Total sleep time from sleep diary

Mean total sleep time per night in minutes from sleep diary

Time frame: Post-2 (after 6-week treatment phase 2)

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

Time frame: Post-1 (after 6-week treatment phase 1)

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

Time frame: Post-2 (after 6-week treatment phase 2)

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

Time frame: Post-1 (after 6-week treatment phase 1)

Central Contacts

Manon Lamy

CONTACT

418-656-2131 manon.lamy@psy.ulaval.ca

Data from ClinicalTrials.gov

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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

Time frame: Post-2 (after 6-week treatment phase 2)

Total sleep time from actigraphy

Mean total sleep time per night in minutes from actigraphy

Time frame: Post-1 (after 6-week treatment phase 1)

Total sleep time from actigraphy

Mean total sleep time per night in minutes from actigraphy

Time frame: Post-2 (after 6-week treatment phase 2)

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

Time frame: Post-1 (after 6-week treatment phase 1)

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

Time frame: Post-2 (after 6-week treatment phase 2)

Sleep efficiency from actigraphy

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)

Sleep efficiency from actigraphy

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)

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)

Time frame: Post-1 (after 6-week treatment phase 1)

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)

Time frame: Post-2 (after 6-week treatment phase 2)

Depression

Patient Health Questionnaire (PHQ-9)

Time frame: Post-1 (after 6-week treatment phase 1)

Depression

Patient Health Questionnaire (PHQ-9)

Time frame: Post-2 (after 6-week treatment phase 2)

Anxiety

Generalized Anxiety Disorder 7-item (GAD-7)

Time frame: Post-1 (after 6-week treatment phase 1)

Anxiety

Generalized Anxiety Disorder 7-item (GAD-7)

Time frame: Post-2 (after 6-week treatment phase 2)

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)

Time frame: Post-1 (after 6-week treatment phase 1)

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)

Time frame: Post-2 (after 6-week treatment phase 2)

Medication use

Frequency of use (number of nights/week)

Time frame: Post-1 (after 6-week treatment phase 1)

Medication use

Frequency of use (number of nights/week)

Time frame: Post-2 (after 6-week treatment phase 2)