NCT03301727

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. Online CBT-I has also been shown to be effective and comparable to in-person CBT-I, and shows promise as an accessible treatment alternative to in-person CBT-I for pregnant women experiencing insomnia. As the harmful consequences of insomnia or sleep disturbances have been well documented during late pregnancy, this randomized-controlled trial will compare the efficacy of both in-person and online CBT-I on pregnant women with insomnia to a wait-list control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 4, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

September 14, 2018

Status Verified

September 1, 2017

Enrollment Period

1.3 years

First QC Date

September 22, 2017

Last Update Submit

September 13, 2018

Conditions

InsomniaSleep Disturbance

Outcome Measures

Primary Outcomes (4)

  • Change in the 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, 8-week follow-up, 3-months postpartum follow-up

  • Change in the 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, 8-week follow-up, 3-months postpartum follow-up

  • Change in Actigraphy (Actiwatch II, Phillips, USA)

    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.

    Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

  • Change in Sleep Logs

    Sleep logs provide self-reported subjective sleep, combining self-reports of: latency, total sleep time, and number and frequency of awakenings.

    Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

Secondary Outcomes (1)

  • Change in the Edinburgh Postpartum Depression Scale

    Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

Other Outcomes (15)

  • Change in the Multidimensional Fatigue Symptom Inventory - Short Form

    Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

  • Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire

    Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

  • Change in the Sleep Self-Efficacy Scale

    Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up

  • +12 more other outcomes

Study Arms (3)

In-person CBT-I Treatment

ACTIVE COMPARATOR

Participants receive 6 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.

Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)

Online CBT-I Treatment

ACTIVE COMPARATOR

Participants receive 6 online weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.

Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)

Wait-list Control

OTHER

Participants are placed on a wait-list for 6 weeks before receiving either in-person or online 6 weekly 1.5-hour sessions of cognitive-behavioural therapy for insomnia (CBT-I) for pregnant women, supervised by a registered, licensed clinical psychologist.

Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)

Interventions

Cognitive-Behavioural Therapy for Insomnia (CBT-I)OTHER

Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.

Also known as: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
In-person CBT-I TreatmentOnline CBT-I TreatmentWait-list Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 years or greater
  • Gestation: 12 - 30 weeks
  • Identifying as experiencing sleep disturbances
  • Language: English-intermediate or above
  • Have access to internet

You may not qualify if:

  • Experiencing symptoms of sleep disorders other than insomnia
  • Currently taking prescribed medications for sleep problems
  • History of untreated, serious psychiatric illness
  • Substance-use during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

  • 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: 39436396DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersParasomnias

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral 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

September 22, 2017

First Posted

October 4, 2017

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

September 14, 2018

Record last verified: 2017-09

Locations

CA(2)