Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

Study Overview
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Brief Summary
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Cognitive-behavioural therapy for insomnia (CBT-I) has been shown to be an effective treatment for insomnia in multiple populations, including women during pregnancy and postpartum. Online CBT-I has also been shown to be effective and comparable to in-person CBT-I, and shows promise as an accessible treatment alternative to in-person CBT-I for pregnant women experiencing insomnia. As the harmful consequences of insomnia or sleep disturbances have been well documented during late pregnancy, this randomized-controlled trial will compare the efficacy of both in-person and online CBT-I on pregnant women with insomnia to a wait-list control group.

Detailed Description
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The primary aim of the current project is to evaluate the impact of a 6-week in-person CBT-I, versus online CBT-I, versus a wait-list in reducing symptoms of insomnia (assessed subjectively by self-report and objectively with actigraphy) experienced in pregnancy. The investigators hypothesize that participants who receive a 6-week program of either in-person CBT-I or online CBT-I (versus a wait-list) will report fewer insomnia symptoms and have improved objectively assessed sleep measured at one-week post-treatment. Based on previous research findings, the investigators do not expect that there will be a difference between in-person CBT-I and online CBT-I administration. The secondary aim is to investigate if CBT-I versus a wait-list will reduce symptoms of depression at one-week post-treatment. The investigators hypothesize that participants who receive in-person CBT-I and online CBT-I (versus a wait-list) will report fewer depressive symptoms measured at one-week post-treatment.

Official Title
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A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Conditions
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Insomnia, Sleep Disturbance

Intervention / Treatment
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* Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 years or greater Gestation: 12 - 30 weeks Identifying as experiencing sleep disturbances Language: English-intermediate or above Have access to internet Exclusion Criteria: Experiencing symptoms of sleep disorders other than insomnia Currently taking prescribed medications for sleep problems History of untreated, serious psychiatric illness Substance-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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person CBT-I Treatment<br>Participants receive 6 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist. | Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)<br>* Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.<br>* Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I);|
| Active Comparator: Online CBT-I Treatment<br>Participants receive 6 online weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist. | Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)<br>* Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.<br>* Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I);|
| Other: Wait-list Control<br>Participants are placed on a wait-list for 6 weeks before receiving either in-person or online 6 weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist. | Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)<br>* Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.<br>* Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Insomnia Severity Index | The ISI is a 7-item questionnaire designed to identify cases of insomnia and evaluate treatment outcomes. The ISI assesses severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and perceived distress caused by sleep problems. It was found to be a clinically useful tool in assessing changes in insomnia symptoms in insomnia treatment research. | Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up | 
| Change in the Pittsburgh Sleep Quality Index | The PSQI instrument is used in assessing one's sleep quality during the previous month. It consists of 19 self-rated items and 5 questions rated by the roommate or bed partner. There are seven components of the PSQI and these are subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction. | Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up | 
| Change in Actigraphy (Actiwatch II, Phillips, USA) | Actigraphy monitoring provides objective sleep, combining measurements of: circadian rhythm amplitude, acrophase, mesor, sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings. | Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up | 
| Change in Sleep Logs | Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings. | Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Edinburgh Postpartum Depression Scale | Symptoms of depression in pregnancy and the postpartum will be assessed by the EPDS. The EPDS consists of 10 items and is a reliable and valid tool for identifying symptoms of depression experienced in pregnancy and the postpartum. | Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up |