Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Insomnia Clinical Trial

Official title:

Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02295345
• Other study ID #: REB14-0356
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: February 2015

Study information

• Verified date: September 2018
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Other:
• Cognitive Behavioural Therapy for Insomnia

Locations

Country	Name	City	State
Canada	University Of Calgary	Calgary	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)