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
| Name | Class |
|---|---|
| University of Alberta | OTHER |
Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.
Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CBT for Insomnia | Experimental | Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioural Therapy for Insomnia | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Actigraphy indices from baseline to post-treatment | Actigraphy is recommended as a reliable and useful method of objective sleep assessment, providing information about indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings | Baseline (Week 1), Post-treatment (Week 7) |
| Change in Sleep Diary variables from baseline to post-treatment | Participants complete a daily, standardized sleep diary on a weekly basis both during the treatment period, and at baseline and final assessment times to corroborate actigraphy data. Dependent variables derived from this data include total sleep time, time in bed, sleep efficiency, and sleep quality | Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7) |
| Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment | The ISI can be used to assess the severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and one's perceived distress caused by sleep problems. Scores on the ISI range from 0 to 28, with scores ≥ 15 indicating clinical insomnia. | Baseline (Week 1), Post-treatment (Week 7) |
| Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment | The PSQI instrument is used in assessing one's sleep quality in the preceding month. It is comprised of 19 self-rated items and 5 questions rated by the roommate or bed partner. The PSQI possesses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. PSQI scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality. | Baseline (Week 1), Post-treatment (Week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment | The EPDS serves as a valuable and efficient way of identifying women at risk for prenatal depression, and can be used for screening both anxiety and depressive symptoms | Baseline (Week 1), Post-treatment (Week 7) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lianne Tomfohr-Madsen, PhD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Calgary | Calgary | Alberta | T2N1N4 | Canada |
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 |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D001523 |
| Mental Disorders |