NCT Number: NCT03301727
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
University of Calgary, Calgary, Alberta, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Cognitive-Behavioral Therapy for Insomnia (CBT-I)
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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
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
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
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
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
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
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
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
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
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
Measure of sleep-related effort.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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
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
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
16-item scale assessing participants' relationship satisfaction.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
44-items assessing personality.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
24-items assessing infant sleep.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
4-items assessing anxiety during pregnancy.
Time frame: Change between 3 time-points: baseline, 8-week follow-up, 3-months postpartum follow-up
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
3-items assessing intensity of pain symptoms.
University of Calgary
Other
A Pilot Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
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