Sleeping For Two: Trial for CBT for Insomnia in Pregnancy

NCT03918057 | Completed DMC

• 1 other identifier: REB19-0465
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Sleep Disturbance

Outcome Measures

Primary Outcomes (10)

• Insomnia Severity Index

  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.

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

• Pittsburgh Sleep Quality Index

  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.

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

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

  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.

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

• Actigraphy (Actiwatch II, Phillips, USA) - Sleep efficiency

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

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

• Actigraphy (Actiwatch II, Phillips, USA) - Sleep latency

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

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

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

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

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

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

  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.

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

• Sleep Logs - Latency

  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.

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

• Sleep Logs - Total sleep time

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

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

• Sleep Logs - Number and frequency of awakenings

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

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

Study Arms (2)

Cognitive-Behavioural Therapy Group

EXPERIMENTAL

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

Treatment as Usual Group

ACTIVE COMPARATOR

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

Interventions

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.

Cognitive-Behavioural Therapy Group

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.

Treatment as Usual Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

• MacKinnon AL, Madsen JW, Dhillon A, Keys E, Giesbrecht GF, Williamson T, Metcalfe A, Campbell T, Mrklas KJ, Tomfohr-Madsen L. Sleeping for two: study protocol for a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnant women. Trials. 2021 Aug 12;22(1):532. doi: 10.1186/s13063-021-05498-w.

  PMID: 34384459 BACKGROUND

• MacKinnon AL, Silang K, Watts D, Kaur J, Freeman M, Dewsnap K, Keys E, Madsen JW, Giesbrecht GF, Williamson T, Metcalfe A, Campbell T, Mrklas KJ, Tomfohr-Madsen LM. Sleeping for Two: a randomized controlled trial of cognitive behavioral therapy for insomnia in pregnancy. J Clin Sleep Med. 2025 Feb 1;21(2):365-376. doi: 10.5664/jcsm.11396.

  PMID: 39436396 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Parasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lianne Tomfohr-Madsen, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2019
• First Posted: April 17, 2019
• Study Start: July 24, 2019
• Primary Completion: November 3, 2021
• Study Completion: January 30, 2022
• Last Updated: October 31, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be made available no later than 6 months after publication, and will be available until study records are destroyed in accordance with research ethics board requirements (min 10 years post collection).

Locations

CA (1)