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Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

Primary Purpose

Insomnia, Sleep Disturbance

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive-Behavioural Therapy for Insomnia (CBT-I)
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Calgary
  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Other

Arm Label

In-person CBT-I Treatment

Online CBT-I Treatment

Wait-list Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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 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 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 in Sleep Logs
Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.

Secondary Outcome Measures

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.

Full Information

First Posted
September 22, 2017
Last Updated
September 13, 2018
Sponsor
University of Calgary
Collaborators
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT03301727
Brief Title
Sleeping for Two: RCT of CBT-Insomnia in Pregnancy
Official Title
A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
University of Manitoba

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-person CBT-I Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Online CBT-I Treatment
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Wait-list Control
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Cognitive-Behavioural Therapy for Insomnia (CBT-I)
Other Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the Insomnia Severity Index
Description
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.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Pittsburgh Sleep Quality Index
Description
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.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in Actigraphy (Actiwatch II, Phillips, USA)
Description
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.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in Sleep Logs
Description
Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Secondary Outcome Measure Information:
Title
Change in the Edinburgh Postpartum Depression Scale
Description
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.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other Pre-specified Outcome Measures:
Title
Change in the Multidimensional Fatigue Symptom Inventory - Short Form
Description
30-item short form version of MFSI was designed to assess manifestations of fatigue.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire
Description
Cognitive scale of 16 items used for assessing problematic levels of unhelpful beliefs about sleep.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Sleep Self-Efficacy Scale
Description
9-item scale used for measuring one's level of confidence in carrying out specific sleep-related behaviors.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Sleep Hygiene Index
Description
13-item self-report items used for assessing presence of behaviors thought to compromise sleep hygiene.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Pre-Sleep Arousal Scale
Description
16-item self-report measure assessing pre-sleep arousal.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Glasgow Sleep Effort Scale
Description
Measure of sleep-related effort.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Sleep-Related Behaviors Questionnaire
Description
Designed to assess use of safety behaviours to promote sleep and cope with tiredness.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Epworth Sleepiness Scale
Description
8-item scale designed to assess the tendency to fall asleep in situations
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Generalized Anxiety Disorder index
Description
Brief measure for assessing symptoms of generalized anxiety disorder.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Couple Satisfaction Index
Description
16-item scale assessing participants' relationship satisfaction.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Big Five Inventory
Description
44-items assessing personality.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Extended Brief Infant Sleep Questionnaire
Description
24-items assessing infant sleep.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the Pregnancy-Specific Anxiety Measure
Description
4-items assessing anxiety during pregnancy.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a
Description
8-items assessing interference of pain in functioning.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Title
Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a
Description
3-items assessing intensity of pain symptoms.
Time Frame
Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lianne Tomfohr-Madsen, PhD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3T 2N2
Country
Canada

12. IPD Sharing Statement

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Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

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