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Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

NCT03301727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-09-14

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Cognitive-Behavioural Therapy for Insomnia (CBT-I)

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.

Sponsors & Collaborators

  • University of Manitoba

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Lianne Tomfohr-Madsen, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-03-31
Completion
2018-03-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03301727 on ClinicalTrials.gov