Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Disturbance
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy for Insomnia; Other: Active Control

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive-Behavioural Therapy Group; 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.	Behavioral: Cognitive Behavioural Therapy for Insomnia; Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Specifically, this therapy provides psychoeducation about thoughts contributing to the maintenance of sleep problems, and instruction in behavioural techniques to help decrease sleep onset latency and promote effective sleep maintenance.
Active Comparator: Treatment as Usual Group; 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.	Other: Active Control; Participants will receive regular obstetric care and will be placed on a wait-list for CBT-I treatment after their final assessment. All activities women try for improving their own sleep problems between assessments will be recorded and coded for.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, 7-week follow-up, 6-months postpartum follow-up.
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, 7-week follow-up, 6-months postpartum follow-up.
Actigraphy (Actiwatch II, Phillips, USA) - Circadian rhythm amplitude, acrophase, mesor	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.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Actigraphy (Actiwatch II, Phillips, USA) - Sleep efficiency	Actigraphy monitoring provides objective sleep data. A sleep efficiency value is recorded by the actigrapher and will be reported.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Actigraphy (Actiwatch II, Phillips, USA) - Sleep latency	Actigraphy monitoring provides objective sleep data. A sleep latency value is recorded by the actigrapher and will be reported.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Actigraphy (Actiwatch II, Phillips, USA) - Total sleep time	Actigraphy monitoring provides objective sleep data. A total sleep time value is recorded by the actigrapher and will be reported.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Actigraphy (Actiwatch II, Phillips, USA) - Number and frequency of awakenings	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.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Sleep Logs - Latency	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.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Sleep Logs - Total sleep time	Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up
Sleep Logs - Number and frequency of awakenings	Sleep logs provide self-reported subjective sleep. Participants will be asked to report on the number of times they woke up during nighttime sleep.	Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Lianne Tomfohr-Madsen, PhD, University of Calgary

Publications and helpful links

General Publications

• MacKinnon AL, Madsen JW, Dhillon A, Keys E, Giesbrecht GF, Williamson T, Metcalfe A, Campbell T, Mrklas KJ, Tomfohr-Madsen L. Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. Trials. 2021 Aug 12;22(1):532. doi: 10.1186/s13063-021-05498-w.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Actual): November 3, 2021
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 27, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Dyssomnias; Parasomnias
• Other Study ID Numbers: REB19-0465

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Recognizing the importance of sharing results, data will be shared in accordance with the International Committee of Medical Journal Editors' guidelines, which state that authors share with others the deidentified individual patient data underlying results presented in the trial reports (including tables, figures, and appendices or supplementary material) no later than 6 months after publication. Data will be made available upon request to the primary investigator.
• IPD Sharing Time Frame: Data will be made available no later than 6 months after publication, and will be available until study records are destroyed in accordance with research ethics board requirements (min 10 years post collection).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No