Clinical trial NCT03301727: Sleeping for Two: RCT of CBT-Insomnia in Pregnancy
Official title: A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep Disturbance
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: University of Manitoba
First posted: 2017-10-04
Enrollment: 54
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the Insomnia Severity Index
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Pittsburgh Sleep Quality Index
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in Actigraphy (Actiwatch II, Phillips, USA)
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in Sleep Logs
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Secondary outcomes:
measure: Change in the Edinburgh Postpartum Depression Scale
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other outcomes:
measure: Change in the Multidimensional Fatigue Symptom Inventory - Short Form
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Sleep Self-Efficacy Scale
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Sleep Hygiene Index
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Pre-Sleep Arousal Scale
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Glasgow Sleep Effort Scale
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Sleep-Related Behaviors Questionnaire
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Epworth Sleepiness Scale
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Generalized Anxiety Disorder index
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Couple Satisfaction Index
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Big Five Inventory
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Extended Brief Infant Sleep Questionnaire
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the Pregnancy-Specific Anxiety Measure
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
measure: Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a
timeFrame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Calgary
name: Lianne Tomfohr-Madsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: