Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

Not Applicable

Completed

• Conditions: Sleep Disturbance; Insomnia
• Interventions: Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)

• Registration Number: NCT03301727
• Lead Sponsor: University of Calgary

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-11
• Status Verified: 2017-09
• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-09-29
• Study First Posted: 2017-10-04
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
In-person CBT-I Treatment	Cognitive-Behavioural Therapy for Insomnia (CBT-I)	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.
Online CBT-I Treatment	Cognitive-Behavioural Therapy for Insomnia (CBT-I)	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.
Wait-list Control	Cognitive-Behavioural Therapy for Insomnia (CBT-I)	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.

Primary Outcome Measures

Name	Time	Method
Change in the Pittsburgh Sleep Quality Index	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up	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 in Actigraphy (Actiwatch II, Phillips, USA)	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up	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 in Sleep Logs	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up	Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
Change in the Insomnia Severity Index	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Change in the Edinburgh Postpartum Depression Scale	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up	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.

Trial Locations

Locations (2)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada