Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT03918057
Status:
COMPLETED
Last Update Posted:
2023-10-31
First Post:
2019-04-12
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleeping For Two: Trial for CBT for Insomnia in Pregnancy
Sponsor:
University of Calgary
Organization:
Study Overview
Official Title:
A Randomized Controlled Trial of Cognitive Behavioural Therapy for Insomnia in Pregnancy
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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. This randomized-controlled trial will compare the efficacy of CBT-I for pregnant women with insomnia to a treatment as usual group.
Detailed Description:
Sleep disturbances are common during pregnancy and typically worsen as pregnancy progresses.Treating antenatal insomnia with pharmacotherapy effectively improves sleep quality and confers a protective benefit against the onset of postpartum depression; however, data suggests that pregnant women are reluctant to take prescribed medications due to perception of risk.
A large body of research has demonstrated that CBT-I has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of CBT-I in pregnancy, which was conducted by our group. Results suggested that CBT-I was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. These results are encouraging, and warrant larger investigations into the efficacy of CBT-I in pregnancy.
Research Question and Objectives:
The current proposal is an extension of a pilot study into a randomized design of in-person CBT-I compared to a treatment as usual (TAU) control for the treatment of insomnia experienced in pregnancy.
The primary aim of the current project is to evaluate the impact of a 5-week in-person CBT-I versus a control group 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 5-week program CBT-I (versus TAU) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured post-treatment.
A large body of research has demonstrated that CBT-I has short-term efficacy equivalent to medication, while long-term results suggest that it outperforms medication. Despite the literature showing cognitive behavioural therapy for insomnia (CBT-I) to be effective in a variety of populations including postpartum women, and the demonstrated harmful consequences of sleep disturbances in late pregnancy, there have been few pilot studies examining the effectiveness of CBT-I in pregnancy, which was conducted by our group. Results suggested that CBT-I was effective and acceptable in reducing both objective and subjective indices of sleep quality and quantity of insomnia. These results are encouraging, and warrant larger investigations into the efficacy of CBT-I in pregnancy.
Research Question and Objectives:
The current proposal is an extension of a pilot study into a randomized design of in-person CBT-I compared to a treatment as usual (TAU) control for the treatment of insomnia experienced in pregnancy.
The primary aim of the current project is to evaluate the impact of a 5-week in-person CBT-I versus a control group 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 5-week program CBT-I (versus TAU) will report fewer insomnia symptoms and have improved objectively assessed sleep as measured post-treatment.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: