An interventional study of Cognitive-Behavioural Therapy for Insomnia (CBT-I) in Insomnia and Sleep Disturbance, sponsored by University of Calgary. Completed at 2 sites in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-14.
Sponsored by University of Calgary · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
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.
Other: Cognitive-Behavioural Therapy for Insomnia (CBT-I)
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.
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.
Also known as: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Multidimensional Fatigue Symptom Inventory - Short Form
30-item short form version of MFSI was designed to assess manifestations of fatigue.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Sleep Hygiene Index
13-item self-report items used for assessing presence of behaviors thought to compromise sleep hygiene.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Pre-Sleep Arousal Scale
16-item self-report measure assessing pre-sleep arousal.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Glasgow Sleep Effort Scale
Measure of sleep-related effort.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Sleep-Related Behaviors Questionnaire
Designed to assess use of safety behaviours to promote sleep and cope with tiredness.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Epworth Sleepiness Scale
8-item scale designed to assess the tendency to fall asleep in situations
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Generalized Anxiety Disorder index
Brief measure for assessing symptoms of generalized anxiety disorder.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Couple Satisfaction Index
16-item scale assessing participants' relationship satisfaction.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Big Five Inventory
44-items assessing personality.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Extended Brief Infant Sleep Questionnaire
24-items assessing infant sleep.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the Pregnancy-Specific Anxiety Measure
4-items assessing anxiety during pregnancy.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the PROMIS Adult Version 1.0 Pain Interference Short Form 8a
8-items assessing interference of pain in functioning.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
Change in the PROMIS Adult Version 1.0 Pain Intensity Short Form 3a
3-items assessing intensity of pain symptoms.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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Sleep Initiation and Maintenance Disorders→
University of Calgary