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| ID | Type | Description | Link |
|---|---|---|---|
| HSCF 176 |
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Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia, such treatments are underutilized. This study evaluates the impact of a 6-week, online treatment for insomnia.
Design This is a randomized controlled trial with online treatment and waiting list control conditions.
Participants
Participants are adults in Manitoba Canada with chronic insomnia.
Setting
Participants receive online treatment from their homes. Intervention. Online treatment consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help with medication tapering. Measurement and Results. The impact of online treatment on primary end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waiting list control | No Intervention | ||
| CBT | Experimental | A 6 weeks online course. Each week participants log on to view videos and read information that focus on a variety of intervention techniques. These include relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training. Participants also monitor their sleep using an online sleep diary and respond to questions regarding their adherence to the program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?" And "How enjoyable was your sleep last night?" (0 = not at all, 4 = very). | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pre-Sleep Arousal | Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. | 6 weeks |
| Beliefs and Attitudes About Sleep |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norah Vincent, Ph.D. | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Manitoba | Winnipeg | Manitoba | R3E 3N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23286463 | Derived | Vincent N, Walsh K, Lewycky S. Determinants of success for computerized cognitive behavior therapy: examination of an insomnia program. Behav Sleep Med. 2013;11(5):328-42. doi: 10.1080/15402002.2012.700662. Epub 2013 Jan 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Waiting List Control | |
| FG001 | Cognitive Behavioral Therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Waiting List Control | |
| BG001 | Cognitive Behavioral Therapy | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sleep Quality | Sleep Quality was assessed by taking the average of two items: "How well do you feel this morning?" And "How enjoyable was your sleep last night?" (0 = not at all, 4 = very). | Posted | Mean | Standard Deviation | 0-4 scale of sleep quality | 6 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Waiting List Control |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | University of Manitoba | 204-787-5098 | NVincent@exchange.hsc.mb.ca |
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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 |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| 6 weeks |
Total of all reporting groups
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Total Sleep Time | Total sleep time is collected from patients self-report weekly sleep diaries. It is the length of time spent in bed minus sleep onset latency and time spent awake in bed. | Mean | Full Range | Hours |
|
|
| Secondary | Pre-Sleep Arousal | Pre-sleep Arousal Scale (cognitive subscale). 8-item measure of cognitive hyperarousal associated with insomnia. The subscale score can range from 8 to 40, with higher scores indicating more hyperarousal. | Posted | Mean | Standard Deviation | PSA Scale | 6 weeks |
|
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| Secondary | Beliefs and Attitudes About Sleep | Not Posted | 6 weeks |
| 0 |
| 59 |
| 0 |
| 0 |
| EG001 | Cognitive Behavioral Therapy | 0 | 59 | 0 | 0 |
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| D001523 |
| Mental Disorders |