Insomnia Disorder
Conditions
Keywords
Insomnia, Pragmatic Clinical Trial, Drug Therapy, Cognitive Behavior Therapy, Primary Care
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.
Interventions
DRUGHypnotics
Medication used 1 to 7 nights/week for 6 to 8 weeks.
BEHAVIORALOnline CBT
Internet self-help program for insomnia with 6 cores.
BEHAVIORALFace-to-face CBT
Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
Sponsors
Canadian Institutes of Health Research (CIHR)
Laval University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remission of insomnia | Post-1 (after 6-week treatment phase 1) | Insomnia Severity Index score (average of two consecutive weeks \< 8, with none \> 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety | Post-1 (after 6-week treatment phase 1) | Generalized Anxiety Disorder 7-item (GAD-7) |
| Disability | Post-1 (after 6-week treatment phase 1) | Work and Social Adjustment Scale (5-item scale scale assessing functional impact of insomnia; total score ranging from 0 to 40, higher scores indicating greater disability) |
| Medication use | Post-1 (after 6-week treatment phase 1) | Frequency of use (number of nights/week) |
| Total sleep time from sleep diary | Post-1 (after 6-week treatment phase 1) | Mean total sleep time per night in minutes from sleep diary |
| Total wake time from sleep diary | Post-1 (after 6-week treatment phase 1) | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary |
| Depression | Post-1 (after 6-week treatment phase 1) | Patient Health Questionnaire (PHQ-9) |
| Total sleep time from actigraphy | Post-1 (after 6-week treatment phase 1) | Mean total sleep time per night in minutes from actigraphy |
| Total wake time from actigraphy | Post-1 (after 6-week treatment phase 1) | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy |
| Sleep efficiency from actigraphy | Post-1 (after 6-week treatment phase 1) | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy |
| Fatigue | Post-1 (after 6-week treatment phase 1) | Flinders Fatigue Scale (7-item self-report scale measuring fatigue over the past two weeks; total score ranges from 0 to 31, higher scores indicating greater fatigue) |
| Sleep efficiency from sleep diary | Post-1 (after 6-week treatment phase 1) | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary |
Countries
Canada
Contacts
Primary ContactManon Lamy
Outcome results
None listed