Clinical trial NCT03633305: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia Disorder
Keywords: Insomnia
Pragmatic Clinical Trial
Drug Therapy
Cognitive Behavior Therapy
Primary Care
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2018-08-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Remission of insomnia
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Remission of insomnia
timeFrame: Post-2 (after 6-week treatment phase 2)
Secondary outcomes:
measure: Total sleep time from sleep diary
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Total sleep time from sleep diary
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Total wake time from sleep diary
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Total wake time from sleep diary
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Sleep efficiency from sleep diary
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Sleep efficiency from sleep diary
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Total sleep time from actigraphy
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Total sleep time from actigraphy
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Total wake time from actigraphy
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Total wake time from actigraphy
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Sleep efficiency from actigraphy
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Sleep efficiency from actigraphy
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Fatigue
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Fatigue
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Depression
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Depression
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Anxiety
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Anxiety
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Disability
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Disability
timeFrame: Post-2 (after 6-week treatment phase 2)
measure: Medication use
timeFrame: Post-1 (after 6-week treatment phase 1)
measure: Medication use
timeFrame: Post-2 (after 6-week treatment phase 2)
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Université Laval Centre d'étude des troubles du sommeil
name: Charles Morin, PhD
role: PRINCIPAL_INVESTIGATOR
References: