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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual | Active Comparator | Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks |
|
| Online cognitive behavior therapy | Experimental | Online CBT- Internet self-help program for insomnia with 6 cores |
|
| Treatment as usual + Online CBT | Experimental | 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 | Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4) |
|
| In-person cognitive behavior therapy | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypnotics | Drug | Medication used 1 to 7 nights/week for 6 to 8 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission of insomnia | Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10) | Post-1 (after 6-week treatment phase 1) |
| Remission of insomnia | Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10) | Post-2 (after 6-week treatment phase 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Total sleep time from sleep diary | Mean total sleep time per night in minutes from sleep diary | Post-1 (after 6-week treatment phase 1) |
| Total sleep time from sleep diary | Mean total sleep time per night in minutes from sleep diary |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manon Lamy | Contact | 418-656-2131 | 12467 | manon.lamy@psy.ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Charles Morin, PhD | Université Laval Centre d'étude des troubles du sommeil | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University | Recruiting | Québec | Quebec | G1K 0A6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40570832 | Derived | 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. | |
| 40373353 | Derived | 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. |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D006993 | Hypnotics and Sedatives |
| ID | Term |
|---|---|
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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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.
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| 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. |
|
| Post-2 (after 6-week treatment phase 2) |
| Total wake time from sleep diary | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary | Post-1 (after 6-week treatment phase 1) |
| Total wake time from sleep diary | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from sleep diary | Post-2 (after 6-week treatment phase 2) |
| Sleep efficiency from sleep diary | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary | Post-1 (after 6-week treatment phase 1) |
| Sleep efficiency from sleep diary | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from sleep diary | Post-2 (after 6-week treatment phase 2) |
| Total sleep time from actigraphy | Mean total sleep time per night in minutes from actigraphy | Post-1 (after 6-week treatment phase 1) |
| Total sleep time from actigraphy | Mean total sleep time per night in minutes from actigraphy | Post-2 (after 6-week treatment phase 2) |
| Total wake time from actigraphy | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy | Post-1 (after 6-week treatment phase 1) |
| Total wake time from actigraphy | Mean total wake time (combining sleep onset latency, wake after sleep onset, and duration of early morning awakening) in minutes from actigraphy | Post-2 (after 6-week treatment phase 2) |
| Sleep efficiency from actigraphy | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy | Post-1 (after 6-week treatment phase 1) |
| Sleep efficiency from actigraphy | Mean sleep efficiency in percentage (total sleep time divided by time spent in bed, multiplied by 100) from actigraphy | Post-2 (after 6-week treatment phase 2) |
| Fatigue | 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) | Post-1 (after 6-week treatment phase 1) |
| Fatigue | 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) | Post-2 (after 6-week treatment phase 2) |
| Depression | Patient Health Questionnaire (PHQ-9) | Post-1 (after 6-week treatment phase 1) |
| Depression | Patient Health Questionnaire (PHQ-9) | Post-2 (after 6-week treatment phase 2) |
| Anxiety | Generalized Anxiety Disorder 7-item (GAD-7) | Post-1 (after 6-week treatment phase 1) |
| Anxiety | Generalized Anxiety Disorder 7-item (GAD-7) | Post-2 (after 6-week treatment phase 2) |
| Disability | 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) | Post-1 (after 6-week treatment phase 1) |
| Disability | 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) | Post-2 (after 6-week treatment phase 2) |
| Medication use | Frequency of use (number of nights/week) | Post-1 (after 6-week treatment phase 1) |
| Medication use | Frequency of use (number of nights/week) | Post-2 (after 6-week treatment phase 2) |
| D001523 |
| Mental Disorders |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |