Recruiting

Insomnia Treatments

Sponsor:

Laval University

Code:

NCT03633305

Conditions

Insomnia Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hypnotics

Online CBT

Face-to-face CBT

Study Details

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.

Conditions

Insomnia Disorder

Study ID

NCT03633305

Start date

Sep 1, 2018

Status verified date

Apr, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment as usual

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

experimental: Online cognitive behavior therapy

Online CBT- Internet self-help program for insomnia with 6 cores

experimental: 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

experimental: Medication

Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4)

experimental: 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.

no intervention: No additional treatment

Interventions

Hypnotics

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

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.

Primary outcome measure

  • Remission of insomnia [ Time Frame: Post-1 (after 6-week treatment phase 1) ]
  • Remission of insomnia [ Time Frame: Post-2 (after 6-week treatment phase 2) ]

Central Contacts and Locations

Central contacts

Manon Lamy

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

Locations

Laval University

Recruiting

Quebec City, Quebec, Canada, G1K 0A6

Contacts

Manon Lamy

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

Principal Investigator:

Charles M Morin, PhD

More Information

Sponsor

Laval University

Last update posted

Apr 6, 2022

Last verified

Apr, 2022

Keywords

  • Insomnia
  • Pragmatic Clinical Trial
  • Drug Therapy
  • Cognitive Behavior Therapy
  • Primary Care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2022-04-06.