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Optimization of Insomnia Treatment in Primary Care

NCT03633305 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-04-06

No results posted yet for this study

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

Interventions

DRUG

Hypnotics

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

BEHAVIORAL

Online CBT

Internet self-help program for insomnia with 6 cores.

BEHAVIORAL

Face-to-face CBT

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

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Laval University

    lead OTHER

Principal Investigators

  • Charles Morin, PhD · Université Laval Centre d'étude des troubles du sommeil

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633305 on ClinicalTrials.gov