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Completed

NCT Number: NCT03918057

Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

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. This randomized-controlled trial will compare the efficacy of CBT-I for pregnant women with insomnia to a treatment as usual group.

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Key information

Conditions

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

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

About this study

Sleep disturbances are common during pregnancy and typically worsen as pregnancy progresses.Treating antenatal insomnia with pharmacotherapy effectively improves sleep quality and confers a protective benefit against the onset of postpartum depression; however, data suggests that pregnant women are reluctant to take prescribed medications due to perception of risk.

A large body of research has demonstrated that CBT-I has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of CBT-I in pregnancy, which was conducted by our group. Results suggested that CBT-I was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. These results are encouraging, and warrant larger investigations into the efficacy of CBT-I in pregnancy.

Research Question and Objectives:

The current proposal is an extension of a pilot study into a randomized design of in-person CBT-I compared to a treatment as usual (TAU) control for the treatment of insomnia experienced in pregnancy.

The primary aim of the current project is to evaluate the impact of a 5-week in-person CBT-I versus a control group 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 5-week program CBT-I (versus TAU) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured post-treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At or over the age of 18
  • Between 12 and 28 weeks pregnant
  • Are able to read, write and speak in English
  • Have a diagnosis of insomnia according to the DSM-V criteria.

Exclusion criteria

  • Experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome [RLS], sleep-disordered breathing [SDB]
  • Having a history of untreated, serious psychiatric illness (i.e., bipolar disorder, schizophrenia)
  • Active suicidal ideation
  • Currently taking prescribed medications for sleep problems
  • Smoking, drinking alcohol or drug abuse during pregnancy
  • Being pregnant with multiples
  • Diagnosis of chronic pain.

Treatment and study plan

Cognitive Behavioural Therapy for Insomnia

Behavioral

Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Specifically, this therapy provides psychoeducation about thoughts contributing to the maintenance of sleep problems, and instruction in behavioural techniques to help decrease sleep onset latency and promote effective sleep maintenance.

Active Control

Other

Participants will receive regular obstetric care and will be placed on a wait-list for CBT-I treatment after their final assessment. All activities women try for improving their own sleep problems between assessments will be recorded and coded for.

Primary outcomes

  1. Insomnia Severity Index

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up.

    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.

  2. Pittsburgh Sleep Quality Index

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up.

    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.

  3. Actigraphy (Actiwatch II, Phillips, USA) - Circadian rhythm amplitude, acrophase, mesor

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Actigraphy monitoring provides objective sleep data. The values for circadian rhythm amplitude, acrophase, and mesor will be combined for each participant to describe their full Circadian rhythm.

  4. Actigraphy (Actiwatch II, Phillips, USA) - Sleep efficiency

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Actigraphy monitoring provides objective sleep data. A sleep efficiency value is recorded by the actigrapher and will be reported.

  5. Actigraphy (Actiwatch II, Phillips, USA) - Sleep latency

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Actigraphy monitoring provides objective sleep data. A sleep latency value is recorded by the actigrapher and will be reported.

  6. Actigraphy (Actiwatch II, Phillips, USA) - Total sleep time

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Actigraphy monitoring provides objective sleep data. A total sleep time value is recorded by the actigrapher and will be reported.

  7. Actigraphy (Actiwatch II, Phillips, USA) - Number and frequency of awakenings

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Actigraphy monitoring provides objective sleep data. The number of times participants wake up during nighttime sleep is recorded by the actigrapher and will be reported.

  8. Sleep Logs - Latency

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Sleep logs provide self-reported subjective sleep. One of the variables participants will report is the amount of time they think it takes them to fall asleep.

  9. Sleep Logs - Total sleep time

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Sleep logs provide self-reported subjective sleep. Participants will be asked to report on their estimated total sleep time.

  10. Sleep Logs - Number and frequency of awakenings

    Time frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up

    Sleep logs provide self-reported subjective sleep. Participants will be asked to report on the number of times they woke up during nighttime sleep.

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 17, 2019
Registry last updated
Oct 31, 2023

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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