Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Hypnotics
- Conditions
- Insomnia Disorder
- Sponsor
- Laval University
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Remission of insomnia
- Last Updated
- 4 years ago
Overview
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.
Investigators
Charles M. Morin
Professor
Laval University
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
Arms & Interventions
Treatment as usual
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks
Intervention: Hypnotics
Online cognitive behavior therapy
Online CBT- Internet self-help program for insomnia with 6 cores
Intervention: Online CBT
Treatment as usual + 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
Intervention: Hypnotics
Treatment as usual + 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
Intervention: Online CBT
Medication
Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)
Intervention: Hypnotics
In-person cognitive behavior therapy
Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Intervention: Face-to-face CBT
Outcomes
Primary Outcomes
Remission of insomnia
Time Frame: Post-2 (after 6-week treatment phase 2)
Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10)
Secondary Outcomes
- Total sleep time from sleep diary(Post-2 (after 6-week treatment phase 2))
- Sleep efficiency from actigraphy(Post-2 (after 6-week treatment phase 2))
- Depression(Post-2 (after 6-week treatment phase 2))
- Anxiety(Post-2 (after 6-week treatment phase 2))
- Disability(Post-2 (after 6-week treatment phase 2))
- Medication use(Post-2 (after 6-week treatment phase 2))
- Total wake time from sleep diary(Post-2 (after 6-week treatment phase 2))
- Sleep efficiency from sleep diary(Post-2 (after 6-week treatment phase 2))
- Total sleep time from actigraphy(Post-2 (after 6-week treatment phase 2))
- Total wake time from actigraphy(Post-2 (after 6-week treatment phase 2))
- Fatigue(Post-2 (after 6-week treatment phase 2))