Open Pilot of Cognitive Behavioural Therapy for Insomnia in Pregnancy

NCT ID: NCT02295345

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-02-28

Brief Summary

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Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, as well as the demonstrated harmful consequences of sleep disturbances in late pregnancy, no trials have investigated its efficacy during pregnancy. This project will investigate the efficacy and acceptability of cognitive behavioral therapy for insomnia (CBT-I) in pregnancy.

Detailed Description

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Study details are included in the publication listed here: https://www.ncbi.nlm.nih.gov/pubmed/27124405

Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT for Insomnia

Participants attend 5 weekly sessions of Cognitive Behavioural Therapy for Insomnia for pregnant women, administered by licensed clinical psychologist.

Group Type EXPERIMENTAL

Cognitive Behavioural Therapy for Insomnia

Intervention Type OTHER

Interventions

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Cognitive Behavioural Therapy for Insomnia

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* English speaking women
* Over the age of 18
* Between twelve and twenty-eight weeks of gestation
* Identify as experiencing sleep disturbances will be recruited.

Exclusion Criteria

* Women who identify as experiencing symptoms of sleep disorders other than insomnia (i.e. restless legs syndrome, obstructive sleep apnea)
* Women who are experiencing a current major depressive episode, or have been diagnosed with bipolar disorder or other disorders that have a psychotic, dissociative, hallucinatory, or delusional component
* Currently taking prescribed medications for sleep problems
* Inability to attend at least 4 out of the 5 weekly therapy sessions, participate in the assessments
* Smoking, drinking alcohol or drug use during pregnancy.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

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Lianne Tomfohr-Madsen

Assistant Professor of Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lianne Tomfohr-Madsen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

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University Of Calgary

Calgary, Alberta, Canada

Site Status

Countries

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Canada

Other Identifiers

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REB14-0356

Identifier Type: -

Identifier Source: org_study_id

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