Sleeping for Two: RCT of CBT-Insomnia in Pregnancy

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

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

Clinical Trial Details

NCT number	NCT03301727
Study type	Interventional
Source	University of Calgary
Contact
Status	Completed
Phase	N/A
Start date	November 2016
Completion date	March 2018

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT05963542` - Efficacy of Online Acceptance and Commitment Therapy and Sound Therapy for Patients With Tinnitus and Insomnia	N/A
Completed	`NCT06339853` - Study of Efficacy of Digital Cognitive Behavioral Therapy With Wearable Device for Insomnia	N/A
Recruiting	`NCT04069247` - Effectiveness of eCBT-I on Improving Mental Health in Chinese Youths With Insomnia	N/A
Completed	`NCT04493593` - Internet-delivered CBT-I (Space for Sleep): Pilot and Feasibility	N/A
Recruiting	`NCT06278077` - Neurexan - a Clinical Trial in Short-Term Insomnia Patients	Phase 2
Recruiting	`NCT05956886` - Sleep Chatbot Intervention for Emerging Black/African American Adults	N/A
Completed	`NCT04661306` - The Better Sleep for Supporters With Insomnia Study	N/A
Recruiting	`NCT06207279` - Preliminary Study on the Development and Reliability and Validity of Attention Rating Scale
Recruiting	`NCT06006299` - Investigating the Use of taVNS to Treat Insomnia in Individuals With Breast Cancer (taVNS-insomnia-BC)	N/A
Completed	`NCT03683381` - App-based Intervention for Treating Insomnia Among Patients With Epilepsy	N/A
Completed	`NCT04564807` - Testing an Online Insomnia Intervention	N/A
Completed	`NCT03673397` - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression	N/A
Completed	`NCT04035200` - Safety, Tolerability and Efficacy Study of V117957 in Subjects With Insomnia Associated With Alcohol Cessation	Phase 2
Active, not recruiting	`NCT05027438` - Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention	N/A
Recruiting	`NCT06053840` - An Open-label Trial to Evaluate the Safety and Efficacy of Chloral Hydrate in Patients With Severe Insomnia	Phase 4
Not yet recruiting	`NCT06348082` - Project Women's Insomnia Sleep Health Equity Study (WISHES)	N/A
Not yet recruiting	`NCT06363799` - Osteopathic Protocol for Insomnia in College Students	N/A
Not yet recruiting	`NCT05991492` - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application	N/A
Not yet recruiting	`NCT06025968` - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis	N/A