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出境医 / 临床实验 / Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Insomnia Sleep Disturbance Behavioral: Cognitive Behavioural Therapy for Insomnia Other: Active Control Not Applicable

Detailed Description:

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.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : August 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Cognitive-Behavioural Therapy Group
Participants receive 5 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
Behavioral: Cognitive Behavioural Therapy for Insomnia
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 Comparator: Treatment as Usual Group
Participants receive usual obstetric care and are placed on a wait-list until six months postpartum. All activities or efforts participants make to treat or improve their sleep on their own is recorded and coded. After the final assessment six months postpartum, participants have the option of receiving 1.5-hour sessions (for a total of 5 session) of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
Other: Active Control
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.

Outcome Measures
Primary Outcome Measures :
  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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Lianne Tomfohr-Madsen, PhD 403-220-2243 ltomfohr@ucalgary.ca

Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Tracking Information
First Submitted Date  ICMJE April 12, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 22, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
  • 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.
  • 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.
  • Actigraphy (Actiwatch II, Phillips, USA) [ Time Frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up ]
    Actigraphy monitoring provides objective sleep, combining measurements of: circadian rhythm amplitude, acrophase, mesor, sleep efficiency, sleep latency, total sleep time, and number and frequency of awakenings.
  • Sleep Logs [ Time Frame: Change between 3 time-points: baseline, 7-week follow-up, 6-months postpartum follow-up ]
    Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleeping For Two: Trial for CBT for Insomnia in Pregnancy
Official Title  ICMJE A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Insomnia
  • Sleep Disturbance
Intervention  ICMJE
  • Behavioral: Cognitive Behavioural Therapy for Insomnia
    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.
  • Other: Active Control
    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.
Study Arms  ICMJE
  • Experimental: Cognitive-Behavioural Therapy Group
    Participants receive 5 in-person weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
    Intervention: Behavioral: Cognitive Behavioural Therapy for Insomnia
  • Active Comparator: Treatment as Usual Group
    Participants receive usual obstetric care and are placed on a wait-list until six months postpartum. All activities or efforts participants make to treat or improve their sleep on their own is recorded and coded. After the final assessment six months postpartum, participants have the option of receiving 1.5-hour sessions (for a total of 5 session) of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.
    Intervention: Other: Active Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 12, 2019)
54
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lianne Tomfohr-Madsen, PhD 403-220-2243 ltomfohr@ucalgary.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918057
Other Study ID Numbers  ICMJE REB19-0465
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE Not Provided
PRS Account University of Calgary
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP