Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Insomnia
• Intervention / Treatment: Other: Cognitive Behavioural Therapy for Insomnia

Detailed Description

Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N1N4
      • University of Calgary

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT for Insomnia; Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist.	Other: Cognitive Behavioural Therapy for Insomnia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (Week 1), Post-treatment (Week 7)
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	Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7)
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.	Baseline (Week 1), Post-treatment (Week 7)
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.	Baseline (Week 1), Post-treatment (Week 7)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline (Week 1), Post-treatment (Week 7)

Collaborators and Investigators

• Sponsor: University of Calgary
• Collaborators: University of Alberta

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: October 23, 2014
• First Submitted That Met QC Criteria: November 17, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: REB14-0356