Optimization of Insomnia Treatment in Primary Care

Laval University

Status: Unknown

Conditions: Insomnia Disorder

Treatments: Behavioral: Online CBT; Behavioral: Face-to-face CBT; Drug: Hypnotics

Study type: Interventional

Funder types: Other

Identifiers

NCT03633305

CIHR0083000212

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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300 participants in 6 patient groups

Treatment as usual

Active Comparator group

Description:

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

Treatment:

Drug: Hypnotics

Online cognitive behavior therapy

Experimental group

Description:

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

Treatment:

Behavioral: Online CBT

Treatment as usual + Online CBT

Experimental group

Description:

Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Online CBT- Internet self-help program for insomnia with 6 cores

Treatment:

Behavioral: Online CBT

Drug: Hypnotics

Medication

Experimental group

Description:

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

Treatment:

Drug: Hypnotics

In-person cognitive behavior therapy

Experimental group

Description:

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

Treatment:

Behavioral: Face-to-face CBT

No additional treatment

No Intervention group