Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

A Pilot 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. 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.

Study Overview

• Status: Completed
• Conditions: Insomnia; Sleep Disturbance
• Intervention / Treatment: Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 1N4
      • University of Calgary
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: In-person CBT-I Treatment; 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); 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.; Other Names: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Active Comparator: Online CBT-I Treatment; 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); 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.; Other Names: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Other: Wait-list Control; 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); 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.; Other Names: Cognitive-Behavioral Therapy for Insomnia (CBT-I)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Multidimensional Fatigue Symptom Inventory - Short Form	30-item short form version of MFSI was designed to assess manifestations of fatigue.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire	Cognitive scale of 16 items used for assessing problematic levels of unhelpful beliefs about sleep.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Sleep Self-Efficacy Scale	9-item scale used for measuring one's level of confidence in carrying out specific sleep-related behaviors.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Sleep Hygiene Index	13-item self-report items used for assessing presence of behaviors thought to compromise sleep hygiene.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Pre-Sleep Arousal Scale	16-item self-report measure assessing pre-sleep arousal.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Glasgow Sleep Effort Scale	Measure of sleep-related effort.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Sleep-Related Behaviors Questionnaire	Designed to assess use of safety behaviours to promote sleep and cope with tiredness.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Epworth Sleepiness Scale	8-item scale designed to assess the tendency to fall asleep in situations	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Generalized Anxiety Disorder index	Brief measure for assessing symptoms of generalized anxiety disorder.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Couple Satisfaction Index	16-item scale assessing participants' relationship satisfaction.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Big Five Inventory	44-items assessing personality.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Extended Brief Infant Sleep Questionnaire	24-items assessing infant sleep.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Pregnancy-Specific Anxiety Measure	4-items assessing anxiety during pregnancy.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a	8-items assessing interference of pain in functioning.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a	3-items assessing intensity of pain symptoms.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 4, 2017

Study Record Updates

• Last Update Posted (Actual): September 14, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2017

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: REB15-2137