Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

Not Applicable

Completed

• Conditions: Sleep Disturbance; Insomnia
• Interventions: Behavioral: Cognitive Behavioural Therapy for Insomnia; Other: Active Control

• Registration Number: NCT03918057
• 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. This randomized-controlled trial will compare the efficacy of CBT-I for pregnant women with insomnia to a treatment as usual group.

Detailed Description

Sleep disturbances are common during pregnancy and typically worsen as pregnancy progresses.Treating antenatal insomnia with pharmacotherapy effectively improves sleep quality and confers a protective benefit against the onset of postpartum depression; however, data suggests that pregnant women are reluctant to take prescribed medications due to perception of risk.

A large body of research has demonstrated that CBT-I has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of CBT-I in pregnancy, which was conducted by our group. Results suggested that CBT-I was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. These results are encouraging, and warrant larger investigations into the efficacy of CBT-I in pregnancy.

Research Question and Objectives:

The current proposal is an extension of a pilot study into a randomized design of in-person CBT-I compared to a treatment as usual (TAU) control for the treatment of insomnia experienced in pregnancy.

The primary aim of the current project is to evaluate the impact of a 5-week in-person CBT-I versus a control group 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 5-week program CBT-I (versus TAU) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured 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 First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-12
• Study First Posted: 2019-04-17
• Study Start: 2019-07-24
• Primary Completion: 2021-11-03
• Study Completion: 2022-01-30
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-27
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 62

Inclusion Criteria

• At or over the age of 18
• Between 12 and 28 weeks pregnant
• Are able to read, write and speak in English
• Have a diagnosis of insomnia according to the DSM-V criteria.

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Exclusion Criteria

• Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome [RLS], sleep-disordered breathing [SDB]
• Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia)
• Active suicidal ideation
• Currently taking prescribed medications for sleep problems
• Smoking, drinking alcohol or drug abuse during pregnancy
• Being pregnant with multiples
• Diagnosis of chronic pain.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive-Behavioural Therapy Group	Cognitive Behavioural Therapy for Insomnia	Participants receive 5 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.
Treatment as Usual Group	Active Control	Participants receive usual obstetric care and are placed on a wait-list until six months postpartum. All activities or efforts participants make to treat or improve their sleep on their own is recorded and coded. After the final assessment six months postpartum, participants have the option of receiving 1.5-hour sessions (for a total of 5 session) of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.

Primary Outcome Measures

Name	Time	Method
Actigraphy (Actiwatch II, Phillips, USA) - Number and frequency of awakenings	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Actigraphy monitoring provides objective sleep data. The number of times participants wake up during nighttime sleep is recorded by the actigrapher and will be reported.
Sleep Logs - Latency	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think it takes them to fall asleep.
Actigraphy (Actiwatch II, Phillips, USA) - Circadian rhythm amplitude, acrophase, mesor	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Actigraphy monitoring provides objective sleep data. The values for circadian rhythm amplitude, acrophase, and mesor will be combined for each participant to describe their full Circadian rhythm.
Actigraphy (Actiwatch II, Phillips, USA) - Sleep efficiency	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Actigraphy monitoring provides objective sleep data. A sleep efficiency value is recorded by the actigrapher and will be reported.
Actigraphy (Actiwatch II, Phillips, USA) - Sleep latency	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Actigraphy monitoring provides objective sleep data. A sleep latency value is recorded by the actigrapher and will be reported.
Pittsburgh Sleep Quality Index	Change between 3 time-points: baseline, 7-week follow-up, 6-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.
Insomnia Severity Index	Change between 3 time-points: baseline, 7-week follow-up, 6-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.
Actigraphy (Actiwatch II, Phillips, USA) - Total sleep time	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Actigraphy monitoring provides objective sleep data. A total sleep time value is recorded by the actigrapher and will be reported.
Sleep Logs - Total sleep time	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.
Sleep Logs - Number and frequency of awakenings	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up	Sleep logs provide self-reported subjective sleep. Participants will be asked to report on the number of times they woke up during nighttime sleep.

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada