Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

University of Calgary

Status: Completed

Conditions: Insomnia; Sleep Disturbance

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03301727

REB15-2137

Details and patient eligibility

About

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.

Full description

The primary aim of the current project is to evaluate the impact of a 6-week in-person CBT-I, versus online CBT-I, versus a wait-list 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 6-week program of either in-person CBT-I or online CBT-I (versus a wait-list) will report fewer insomnia symptoms and have improved objectively assessed sleep measured at one-week post-treatment. Based on previous research findings, the investigators do not expect that there will be a difference between in-person CBT-I and online CBT-I administration.

The secondary aim is to investigate if CBT-I versus a wait-list will reduce symptoms of depression at one-week post-treatment. The investigators hypothesize that participants who receive in-person CBT-I and online CBT-I (versus a wait-list) will report fewer depressive symptoms measured at one-week post-treatment.

Enrollment: 54 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

In-person CBT-I Treatment

Active Comparator group

Description:

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.

Treatment:

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

Online CBT-I Treatment

Active Comparator group

Description:

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.

Treatment:

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

Wait-list Control

Other group

Description:

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.

Treatment:

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