Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Study Overview
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Brief Summary
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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.

Detailed Description
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Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405

Official Title
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Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Conditions
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Insomnia

Intervention / Treatment
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* Other: Cognitive Behavioural Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking women Over the age of 18 Between twelve and twenty-eight weeks of gestation Identify as experiencing sleep disturbances will be recruited. Exclusion Criteria: Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea) Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component Currently taking prescribed medications for sleep problems Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments Smoking, drinking alcohol or drug use during pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT for Insomnia<br>Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist. | Other: Cognitive Behavioural Therapy for Insomnia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) |