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Completed

NCT Number: NCT02295345

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Of Calgary

Calgary, Alberta, T2N1N4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Behavioural Therapy for Insomnia

Other

Primary outcomes

  1. Change in Actigraphy indices from baseline to post-treatment

    Time frame: Baseline (Week 1), Post-treatment (Week 7)

    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

  2. Change in Sleep Diary variables from baseline to post-treatment

    Time frame: Baseline (Week 1), Treatment (Weeks 2-6), Post-treatment (Week 7)

    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

  3. Change in Insomnia Severity Index (ISI) scores from baseline to post-treatment

    Time frame: Baseline (Week 1), Post-treatment (Week 7)

    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.

  4. Change in Pittsburgh Sleep Quality Index (PSQI) scores from baseline to post-treatment

    Time frame: Baseline (Week 1), Post-treatment (Week 7)

    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 outcomes

  1. Change in Edinburgh Postpartum Depression Scale (EPDS) scores from baseline to post-treatment

    Time frame: Baseline (Week 1), Post-treatment (Week 7)

    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

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • University of Alberta

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 20, 2014
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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