Back to resultsOpen Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Primary Purpose
Insomnia
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cognitive Behavioural Therapy for Insomnia
Sponsored by
About this trial
This is an interventional treatment trial for Insomnia
Eligibility Criteria
Inclusion Criteria:
- English speaking women
- Over the age of 18
- Between twelve and twenty-eight weeks of gestation
- Identify as experiencing sleep disturbances will be recruited.
Exclusion Criteria:
- Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
- Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
- Currently taking prescribed medications for sleep problems
- Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
- Smoking, drinking alcohol or drug use during pregnancy.
Sites / Locations
- University Of Calgary
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CBT for Insomnia
Arm Description
Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist.
Outcomes
Primary Outcome Measures
Change in Actigraphy indices from baseline to post-treatment
Actigraphy is recommended as a reliable and useful method of objective sleep assessment, providing information about indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings
Change in Sleep Diary variables from baseline to post-treatment
Participants complete a daily, standardized sleep diary on a weekly basis both during the treatment period, and at baseline and final assessment times to corroborate actigraphy data. Dependent variables derived from this data include total sleep time, time in bed, sleep efficiency, and sleep quality
Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment
The ISI can be used to assess the severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and one's perceived distress caused by sleep problems. Scores on the ISI range from 0 to 28, with scores ≥ 15 indicating clinical insomnia.
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment
The PSQI instrument is used in assessing one's sleep quality in the preceding month. It is comprised of 19 self-rated items and 5 questions rated by the roommate or bed partner. The PSQI possesses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. PSQI scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality.
Secondary Outcome Measures
Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment
The EPDS serves as a valuable and efficient way of identifying women at risk for prenatal depression, and can be used for screening both anxiety and depressive symptoms
Full Information
NCT ID
NCT02295345
First Posted
October 23, 2014
Last Updated
September 13, 2018
Sponsor
University of Calgary
Collaborators
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT02295345
Brief Title
Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Official Title
Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary
Collaborators
University of Alberta
4. Oversight
5. Study Description
Brief Summary
Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.
Detailed Description
Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT for Insomnia
Arm Type
Experimental
Arm Description
Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist.
Intervention Type
Other
Intervention Name(s)
Cognitive Behavioural Therapy for Insomnia
Primary Outcome Measure Information:
Title
Change in Actigraphy indices from baseline to post-treatment
Description
Actigraphy is recommended as a reliable and useful method of objective sleep assessment, providing information about indices of sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings
Time Frame
Baseline (Week 1), Post-treatment (Week 7)
Title
Change in Sleep Diary variables from baseline to post-treatment
Description
Participants complete a daily, standardized sleep diary on a weekly basis both during the treatment period, and at baseline and final assessment times to corroborate actigraphy data. Dependent variables derived from this data include total sleep time, time in bed, sleep efficiency, and sleep quality
Time Frame
Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7)
Title
Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment
Description
The ISI can be used to assess the severity of sleep onset, sleep maintenance and early wakening problems, sleep dissatisfaction, and one's perceived distress caused by sleep problems. Scores on the ISI range from 0 to 28, with scores ≥ 15 indicating clinical insomnia.
Time Frame
Baseline (Week 1), Post-treatment (Week 7)
Title
Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment
Description
The PSQI instrument is used in assessing one's sleep quality in the preceding month. It is comprised of 19 self-rated items and 5 questions rated by the roommate or bed partner. The PSQI possesses seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications and daytime dysfunction. PSQI scores range from 0 to 21, with scores greater than 5 indicating poor sleep quality.
Time Frame
Baseline (Week 1), Post-treatment (Week 7)
Secondary Outcome Measure Information:
Title
Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment
Description
The EPDS serves as a valuable and efficient way of identifying women at risk for prenatal depression, and can be used for screening both anxiety and depressive symptoms
Time Frame
Baseline (Week 1), Post-treatment (Week 7)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
English speaking women
Over the age of 18
Between twelve and twenty-eight weeks of gestation
Identify as experiencing sleep disturbances will be recruited.
Exclusion Criteria:
Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
Currently taking prescribed medications for sleep problems
Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
Smoking, drinking alcohol or drug 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
T2N1N4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy
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