Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
| Registry | NCT03633305 |
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| Status | Unknown |
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| Phase | Not applicable |
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| Study type | Interventional; non randomized, sequential, masking: none, treatment |
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| Enrollment | 300 (Estimated) |
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| Sponsor | Laval University (Other); collaborators: Canadian Institutes of Health Research (CIHR) |
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| Conditions | Insomnia Disorder |
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| Interventions | Hypnotics, Online CBT, Face-to-face CBT (Drug, behavioral) |
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| Dates | start 2018-09-01, primary completion 2023-12-01 (estimated), completion 2023-12-01 (estimated), first posted 2018-08-16, last updated 2022-04-06 |
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| Locations | 1 site in Canada |
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-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Treatment as usual | Active comparator | Drug: Hypnotics | Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks |
| Online cognitive behavior therapy | Experimental | Behavioral: Online CBT | Online CBT- Internet self-help program for insomnia with 6 cores |
| Treatment as usual + Online CBT | Experimental | Drug: Hypnotics; Behavioral: 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 |
| Medication | Experimental | Drug: Hypnotics | Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4) |
| In-person cognitive behavior therapy | Experimental | Behavioral: Face-to-face CBT | Face-to-face CBT- Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks. |
| No additional treatment | No intervention | | |
- Hypnotics (Drug): Medication used 1 to 7 nights/week for 6 to 8 weeks.
- Online CBT (Behavioral): Internet self-help program for insomnia with 6 cores.
- Face-to-face CBT (Behavioral): Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
+Outcome measures
Primary outcomes
- Remission of insomnia [Post-1 (after 6-week treatment phase 1)]: Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
- Remission of insomnia [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-1 (after 6-week treatment phase 1)]: Mean total sleep time per night in minutes from sleep diary
- Total sleep time from sleep diary [Post-2 (after 6-week treatment phase 2)]: 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
- Total wake time from sleep diary [Post-2 (after 6-week treatment phase 2)]: Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary
- 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
- Sleep efficiency from sleep diary [Post-2 (after 6-week treatment phase 2)]: Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary
- Total sleep time from actigraphy [Post-1 (after 6-week treatment phase 1)]: Mean total sleep time per night in minutes from actigraphy
- Total sleep time from actigraphy [Post-2 (after 6-week treatment phase 2)]: 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
- Total wake time from actigraphy [Post-2 (after 6-week treatment phase 2)]: 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
- Sleep efficiency from actigraphy [Post-2 (after 6-week treatment phase 2)]: 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)
- Fatigue [Post-2 (after 6-week treatment phase 2)]: 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)
- Depression [Post-1 (after 6-week treatment phase 1)]: Patient Health Questionnaire (PHQ-9)
- Depression [Post-2 (after 6-week treatment phase 2)]: Patient Health Questionnaire (PHQ-9)
- Anxiety [Post-1 (after 6-week treatment phase 1)]: Generalized Anxiety Disorder 7-item (GAD-7)
- Anxiety [Post-2 (after 6-week treatment phase 2)]: 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)
- Disability [Post-2 (after 6-week treatment phase 2)]: 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)
- Medication use [Post-2 (after 6-week treatment phase 2)]: Frequency of use (number of nights/week)
+Eligibility
Sex: All, ages: 18 Years to any
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
+Locations (1)
| Facility | City | Country | Status |
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| Laval University | Québec, Quebec | Canada | Recruiting |
+Publications
- Results publication: Cheung JMY, Ritterband LM, Chen SJ, Ivers H, Morin CM. Stepped-Care Management of Insomnia: Treatment Choices Guided by a Patient Decision Aid in a Pragmatic Nonrandomized Clinical Trial Setting. J Sleep Res. 2026 Feb;35(1):e70127. doi: 10.1111/jsr.70127. Epub 2025 Jun 26. PMID 40570832
- Results publication: Morin CM, Chen SJ, Lemieux K, Ivers H, Cheung JMY, Lamy M, Ritterband L. Stepped care for insomnia in primary care using digital and face-to-face cognitive behavioral therapies: A pragmatic nonrandomized clinical trial. Sleep Med. 2025 Aug;132:106551. doi: 10.1016/j.sleep.2025.106551. Epub 2025 May 3. PMID 40373353
+Investigators
- Charles Morin, PhD, Principal investigator, Université Laval Centre d'étude des troubles du sommeil