Insomnia DisorderNCT03633305
Optimization of Insomnia Treatment in Primary Care
A study testing Hypnotics, Online CBT and Face-to-face CBT in people with Insomnia Disorder, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Hypnotics, Online CBT and Face-to-face CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2018to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Laval University
Québec, Quebec, G1K 0A6
Manon Lamy, 418 656-2131 ext. 12467, manon.lamy@psy.ulaval.ca
Charles M Morin, PhD
About this study
Official title: Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
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
- Being tested
- Hypnotics, Online CBT, Face-to-face CBT
- Keywords
- Insomnia, Pragmatic Clinical Trial, Drug Therapy, Cognitive Behavior Therapy, Primary Care
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypnoticsDrug
Medication used 1 to 7 nights/week for 6 to 8 weeks.
Online CBTBehavioural
Internet self-help program for insomnia with 6 cores.
Face-to-face CBTBehavioural
Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | Active comparator | Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks Receives: Drug: Hypnotics |
| Online cognitive behavior therapy | Experimental | Online CBT- Internet self-help program for insomnia with 6 cores Receives: Behavioral: Online CBT |
| 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 Receives: Drug: Hypnotics; Behavioral: Online CBT |
| Medication | Experimental | Hypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks (arms 1, 3, 4) Receives: Drug: Hypnotics |
| 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. Receives: Behavioral: Face-to-face CBT |
| No additional treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of insomnia
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Measured: Post-1 (after 6-week treatment phase 1)
Remission of insomnia
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Measured: Post-2 (after 6-week treatment phase 2)
Secondary outcomes (22)
Total sleep time from sleep diary
Mean total sleep time per night in minutes from sleep diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post-2 (after 6-week treatment phase 2)
Total sleep time from actigraphy
Mean total sleep time per night in minutes from actigraphy
Measured: Post-1 (after 6-week treatment phase 1)
Total sleep time from actigraphy
Mean total sleep time per night in minutes from actigraphy
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Post-2 (after 6-week treatment phase 2)
Depression
Patient Health Questionnaire (PHQ-9)
Measured: Post-1 (after 6-week treatment phase 1)
Depression
Patient Health Questionnaire (PHQ-9)
Measured: Post-2 (after 6-week treatment phase 2)
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7)
Measured: Post-1 (after 6-week treatment phase 1)
Anxiety
Generalized Anxiety Disorder 7-item (GAD-7)
Measured: 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)
Measured: 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)
Measured: Post-2 (after 6-week treatment phase 2)
Medication use
Frequency of use (number of nights/week)
Measured: Post-1 (after 6-week treatment phase 1)
Medication use
Frequency of use (number of nights/week)
Measured: Post-2 (after 6-week treatment phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Charles M. Morin, Laval University
- Investigators
- Charles Morin, PhD, Principal investigator, Université Laval Centre d'étude des troubles du sommeil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633305
- Sponsor's protocol ID
- CIHR0083000212
- Status last verified
- Apr 2022
- First submitted
- 17 Jul 2018
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40570832Morin 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.
PubMed 40373353
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care Treatment for Insomnia Delivered in Primary Care Clinics: A Pragmatic Clinical Trial
- ClinicalTrials.gov ID
- NCT03633305
- Acronym / sponsor ID
- CIHR0083000212
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia, Pragmatic Clinical Trial, Drug Therapy, Cognitive Behavior Therapy, Primary Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | Active comparator | Drug: HypnoticsHypnotics - Medication used 1 to 7 nights/week for 6 to 8 weeks |
| Online cognitive behavior therapy | Experimental | Behavioral: Online CBTOnline CBT- Internet self-help program for insomnia with 6 cores |
| Treatment as usual + Online CBT | Experimental | Drug: Hypnotics, Behavioral: Online CBTHypnotics - 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: HypnoticsHypnotics - 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 CBTFace-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 | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Unstable or untreated psychiatric disorder
- Lifetime psychotic or bipolar disorder
- Current suicide risk
- Progressive or unstable medical disorder
- Untreated sleep disorder other than insomnia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HypnoticsMedication used 1 to 7 nights/week for 6 to 8 weeks. | Drug | Medication, Treatment as usual, Treatment as usual + Online CBT |
| Online CBTInternet self-help program for insomnia with 6 cores. | Behavioural | Online cognitive behavior therapy, Treatment as usual + Online CBT |
| Face-to-face CBTFace-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks. | Behavioural | In-person cognitive behavior therapy |
Primary outcome
Remission of insomnia
Time frame: Post-1 (after 6-week treatment phase 1)
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
Remission of insomnia
Time frame: Post-2 (after 6-week treatment phase 2)
Insomnia Severity Index score (average of two consecutive weeks < 8, with none > 10)
22 secondary outcomes
Total sleep time from sleep diary
Time frame: Post-1 (after 6-week treatment phase 1)
Total sleep time from sleep diary
Time frame: Post-2 (after 6-week treatment phase 2)
Total wake time from sleep diary
Time frame: Post-1 (after 6-week treatment phase 1)
Total wake time from sleep diary
Time frame: Post-2 (after 6-week treatment phase 2)
Sleep efficiency from sleep diary
Time frame: Post-1 (after 6-week treatment phase 1)
Sleep efficiency from sleep diary
Time frame: Post-2 (after 6-week treatment phase 2)
Total sleep time from actigraphy
Time frame: Post-1 (after 6-week treatment phase 1)
Total sleep time from actigraphy
Time frame: Post-2 (after 6-week treatment phase 2)
Total wake time from actigraphy
Time frame: Post-1 (after 6-week treatment phase 1)
Total wake time from actigraphy
Time frame: Post-2 (after 6-week treatment phase 2)
Sleep efficiency from actigraphy
Time frame: Post-1 (after 6-week treatment phase 1)
Sleep efficiency from actigraphy
Time frame: Post-2 (after 6-week treatment phase 2)
Fatigue
Time frame: Post-1 (after 6-week treatment phase 1)
Fatigue
Time frame: Post-2 (after 6-week treatment phase 2)
Depression
Time frame: Post-1 (after 6-week treatment phase 1)
Depression
Time frame: Post-2 (after 6-week treatment phase 2)
Anxiety
Time frame: Post-1 (after 6-week treatment phase 1)
Anxiety
Time frame: Post-2 (after 6-week treatment phase 2)
Disability
Time frame: Post-1 (after 6-week treatment phase 1)
Disability
Time frame: Post-2 (after 6-week treatment phase 2)
Medication use
Time frame: Post-1 (after 6-week treatment phase 1)
Medication use
Time frame: Post-2 (after 6-week treatment phase 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 40570832Cheung 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.
- Derived from this study: PubMed 40373353Morin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Morin, PhD principal investigator
Université Laval Centre d'étude des troubles du sommeil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnotics, Online CBT and Face-to-face CBT in people with Insomnia Disorder, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manon Lamy (418-656-2131 ext. 12467, manon.lamy@psy.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of insomnia (time frame: Post-1 (after 6-week treatment phase 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03633305, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.