Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

Insomnia Clinical Trial

Official title:

A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301727
• Other study ID #: REB15-2137
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2018

Study information

• Verified date: September 2017
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Calgary	University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the Multidimensional Fatigue Symptom Inventory - Short Form	30-item short form version of MFSI was designed to assess manifestations of fatigue.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Dysfunctional Beliefs and Attitudes about Sleep Questionnaire	Cognitive scale of 16 items used for assessing problematic levels of unhelpful beliefs about sleep.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Sleep Self-Efficacy Scale	9-item scale used for measuring one's level of confidence in carrying out specific sleep-related behaviors.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Sleep Hygiene Index	13-item self-report items used for assessing presence of behaviors thought to compromise sleep hygiene.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Pre-Sleep Arousal Scale	16-item self-report measure assessing pre-sleep arousal.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Glasgow Sleep Effort Scale	Measure of sleep-related effort.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Sleep-Related Behaviors Questionnaire	Designed to assess use of safety behaviours to promote sleep and cope with tiredness.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Epworth Sleepiness Scale	8-item scale designed to assess the tendency to fall asleep in situations	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Generalized Anxiety Disorder index	Brief measure for assessing symptoms of generalized anxiety disorder.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Couple Satisfaction Index	16-item scale assessing participants' relationship satisfaction.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Big Five Inventory	44-items assessing personality.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Extended Brief Infant Sleep Questionnaire	24-items assessing infant sleep.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the Pregnancy-Specific Anxiety Measure	4-items assessing anxiety during pregnancy.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a	8-items assessing interference of pain in functioning.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Other	Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a	3-items assessing intensity of pain symptoms.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Primary	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
Primary	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
Primary	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
Primary	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	Change in the Edinburgh Postpartum Depression Scale	Symptoms of depression in pregnancy and the postpartum will be assessed by the EPDS. The EPDS consists of 10 items and is a reliable and valid tool for identifying symptoms of depression experienced in pregnancy and the postpartum.	Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up