Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness based stress reduction (MBSR) | Experimental | The participants randomized to this arm received the 8-week MBSR program. |
|
| Cognitive Behaviour Therapy for Insomnia (CBT-I) | Active Comparator | The participants randomized to this arm received the 8-week CBT-I treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-based stress reduction (MBSR) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Actigraphy | The actigraph (Actiwatch 2, Philips Respironics, Bend, OR) is a wrist-worn device that measures movement to estimate sleep-wake patterns and activity levels over time. Data are typically reported as total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency. Higher sleep efficiency and longer total sleep time indicate better sleep outcomes, whereas longer sleep onset latency and greater wake after sleep onset indicate worse sleep outcomes. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre d'étude des troubles du sommeil (CETS) de l'université Laval | Québec | Quebec | G1V 0A6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Randomized controlled noninferiority trial
Not provided
Not provided
Not provided
Not provided
|
| Cognitive Behaviour Therapy for Insomnia (CBT-I) | Behavioral | 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. |
|
| 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. | 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. | 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). | 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 |
| Baseline: 10 days recording prior to the start of the 8-week program; Post-treatment: 10 days recording starting within one day after completion of the 8-week program |
| Sleep diary | The Sleep Diary is a daily self-report log used to record sleep patterns, bedtime habits, and related factors to better understand and manage sleep difficulties. Variables derived from the diary include total sleep time, sleep onset latency, wake after sleep onset, and sleep efficiency. Higher sleep efficiency and longer total sleep time indicate better sleep outcomes, whereas longer sleep onset latency and greater wake after sleep onset indicate worse sleep outcomes. | Baseline: 10 days recording prior to the start of the 8-week program; Post-treatment: 10 days recording within one day after completion of the 8-week program; Follow-up: 10 days recording three months after completion of the 8-week program |
| D001523 |
| Mental Disorders |