InsomniaNCT07180784
Psychological Interventions for Students With Insomnia
A study testing Mindfulness-based stress reduction (MBSR) and Cognitive Behaviour Therapy for Insomnia (CBT-I) in people with Insomnia, run by Laval University at 1 site in Canada.
Trial summary
This study looked at university students who had trouble sleeping and compared two different programs designed to help with insomnia. One program was mindfulness-based stress reduction (MBSR), which focuses on meditation and awareness techniques, and the other was cognitive-behavioral therapy for insomnia (CBT-I), a… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Mindfulness-based stress reduction (MBSR) and Cognitive Behaviour Therapy for Insomnia (CBT-I)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2021to 30 Jul 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 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female students aged 18 to 35 years from Université Laval;
- Meet the Diagnostic and Statistical Manual of Mental Disorders 5th Version (DSM-5) criteria for insomnia disorder;
- Report at least one consequence of insomnia on daytime functioning;
- Are available and committed to attending group therapy sessions of approximately 1.5 hours each, held over 8 consecutive weeks.
Who cannot join
- Presence of another major psychiatric disorder or other sleep disorder that could explain the insomnia symptoms;
- Presence of a serious medical condition (e.g., chronic pain);
- Previous participation in cognitive-behavioral therapy for insomnia (CBT-I) or prior completion of a mindfulness-based program (e.g., mindfulness-based stress reduction [MBSR], mindfulness-based cognitive therapy [MBCT]);
- Refusal to discontinue the use of substances (e.g., over-the-counter sleep aids, marijuana, alcohol) for the sole purpose of sleep aids for the duration of the study;
- Having a highly irregular sleep schedule (e.g., going to bed almost every night after 1:00 a.m. and waking up after 10:00 a.m.).
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre d'étude des troubles du sommeil (CETS) de l'université Laval
Québec, Quebec, G1V 0A6
About this study
Official title: Mindfulness-Based Stress Reduction Compared With Cognitive Behavioral Therapy to Improve Sleep and Mental Health in University Students With Insomnia
This study looked at university students who had trouble sleeping and compared two different programs designed to help with insomnia. One program was mindfulness-based stress reduction (MBSR), which focuses on meditation and awareness techniques, and the other was cognitive-behavioral therapy for insomnia (CBT-I), a structured approach that teaches strategies to change thoughts and habits around sleep. Participants were randomly assigned to one of the two programs. The researchers wanted to see how each program affected insomnia symptoms and related factors like stress, anxiety, mood, and overall quality of life. The researchers expected that CBT-I would lead to faster improvements right after the program, but they also believed that the mindfulness program would work just as well in the longer term, notably, three months after treatment.
- Conditions
- Insomnia
- Being tested
- Mindfulness-based stress reduction (MBSR), Cognitive Behaviour Therapy for Insomnia (CBT-I)
- Keywords
- Insomnia, Mindfulness, Cognitive-behavior therapy, Students
- 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.
Mindfulness-based stress reduction (MBSR)Behavioural
An intervention group offered to students that teaches meditation and yoga techniques, stress physiology, and mindfulness practices. Each group includes 5-6 participants and met once a week for 1.5 hours over a period of 8 consecutive weeks.
Cognitive Behaviour Therapy for Insomnia (CBT-I)Behavioural
Traditional CBT-I was offered in small group sessions of 5 to 6 participants and lasted 1.5 hours each. They were held once a week over a period of 8 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness based stress reduction (MBSR) | Experimental | The participants randomized to this arm received the 8-week MBSR program. Receives: Behavioral: Mindfulness-based stress reduction (MBSR) |
| Cognitive Behaviour Therapy for Insomnia (CBT-I) | Active comparator | The participants randomized to this arm received the 8-week CBT-I treatment. Receives: Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire used to evaluate the severity of insomnia symptoms (e.g., difficulties falling asleep). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). Score interpretation: 0-7 = no clinically significant insomnia; 8-14 = subthreshold insomnia; 15-21 = clinical insomnia (moderate severity); 22-28 = clinical insomnia (severe).
Measured: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
Secondary outcomes (4)
The Patient Health Questionnaire-9 (PHQ-9)
The Patient Health Questionnaire-9 (PHQ-9) is a nine-item self-report questionnaire used to assess the severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms (i.e., a worse outcome).
Measured: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Generalized Anxiety Disorder-7 (GAD-7)
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report questionnaire used to assess the severity of generalized anxiety symptoms. Total scores range from 0 to 21, with higher scores indicating greater anxiety severity (worse outcome). Score interpretation: 0-4 = minimal anxiety; 5-9 = mild anxiety; 10-14 = moderate anxiety; 15-21 = severe anxiety.
Measured: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Perceived Stress Scale (PSS-14)
The Perceived Stress Scale (PSS-14) is a 14-item self-report questionnaire that measures the degree to which individuals perceive their life situations as stressful over the past month. Total scores range from 0 to 56, with higher scores indicating greater perceived stress (worse outcome). Score interpretation: 0-13 = low stress; 14-26 = moderate stress; 27-40 = high stress.
Measured: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a 16-item self-report questionnaire that assesses overall satisfaction and enjoyment across various areas of daily functioning and quality of life. Total raw scores range from 14 to 70, which are typically converted into a percentage of the maximum possible score. Higher scores indicate greater enjoyment and satisfaction with quality of life (better outcome).
Measured: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2025
- Study start1 Sep 2021
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled noninferiority trial
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amélie Vézina, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07180784
- Sponsor's protocol ID
- 2021-228 A-1 R-1
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-Based Stress Reduction Compared With Cognitive Behavioral Therapy to Improve Sleep and Mental Health in University Students With Insomnia
- ClinicalTrials.gov ID
- NCT07180784
- Acronym / sponsor ID
- 2021-228 A-1 R-1
- Conditions
- Insomnia
- Keywords
- Insomnia, Mindfulness, Cognitive-behavior therapy, Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 18 Sep 2025 (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.
This study looked at university students who had trouble sleeping and compared two different programs designed to help with insomnia. One program was mindfulness-based stress reduction (MBSR), which focuses on meditation and awareness techniques, and the other was cognitive-behavioral therapy for insomnia (CBT-I), a structured approach that teaches strategies to change thoughts and habits around sleep. Participants were randomly assigned to one of the two programs. The researchers wanted to see how each program affected insomnia symptoms and related factors like stress, anxiety, mood, and overall quality of life. The researchers expected that CBT-I would lead to faster improvements right after the program, but they also believed that the mindfulness program would work just as well in the longer term, notably, three months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled noninferiority trial
| Arm | Type | Receives |
|---|---|---|
| Mindfulness based stress reduction (MBSR) | Experimental | Behavioral: Mindfulness-based stress reduction (MBSR)The participants randomized to this arm received the 8-week MBSR program. |
| Cognitive Behaviour Therapy for Insomnia (CBT-I) | Active comparator | Behavioral: Cognitive Behaviour Therapy for Insomnia (CBT-I)The participants randomized to this arm received the 8-week CBT-I treatment. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male and female students aged 18 to 35 years from Université Laval;
- Meet the Diagnostic and Statistical Manual of Mental Disorders 5th Version (DSM-5) criteria for insomnia disorder;
- Report at least one consequence of insomnia on daytime functioning;
- Are available and committed to attending group therapy sessions of approximately 1.5 hours each, held over 8 consecutive weeks.
Key exclusion criteria (5 listed)
- Presence of another major psychiatric disorder or other sleep disorder that could explain the insomnia symptoms;
- Presence of a serious medical condition (e.g., chronic pain);
- Previous participation in cognitive-behavioral therapy for insomnia (CBT-I) or prior completion of a mindfulness-based program (e.g., mindfulness-based stress reduction [MBSR], mindfulness-based cognitive therapy [MBCT]);
- Refusal to discontinue the use of substances (e.g., over-the-counter sleep aids, marijuana, alcohol) for the sole purpose of sleep aids for the duration of the study;
- Having a highly irregular sleep schedule (e.g., going to bed almost every night after 1:00 a.m. and waking up after 10:00 a.m.).
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 |
|---|---|---|
| Mindfulness-based stress reduction (MBSR)An intervention group offered to students that teaches meditation and yoga techniques, stress physiology, and mindfulness practices. Each group includes 5-6 participants and met once a week for 1.5 hours over a period of 8 consecutive weeks. | Behavioural | Mindfulness based stress reduction (MBSR) |
| Cognitive Behaviour Therapy for Insomnia (CBT-I)Traditional CBT-I was offered in small group sessions of 5 to 6 participants and lasted 1.5 hours each. They were held once a week over a period of 8 consecutive weeks. | Behavioural | Cognitive Behaviour Therapy for Insomnia (CBT-I) |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Insomnia Severity Index (ISI) is a 7-item self-report questionnaire used to evaluate the severity of insomnia symptoms (e.g., difficulties falling asleep). Total scores range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). Score interpretation: 0-7 = no clinically significant insomnia; 8-14 = subthreshold insomnia; 15-21 = clinical insomnia (moderate severity); 22-28 = clinical insomnia (severe).
4 secondary outcomes
The Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Perceived Stress Scale (PSS-14)
Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)
Time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based stress reduction (MBSR) and Cognitive Behaviour Therapy for Insomnia (CBT-I) in people with Insomnia, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Sep 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline: One week prior to the start of the 8-week program; Post-treatment: Within one day after completion of the 8-week program; Follow-up: Three months after completion of the 8-week program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Sep 2025.