Sleeping For Two: Trial for CBT for 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. This randomized-controlled trial will compare the efficacy of CBT-I for pregnant women with insomnia to a treatment as usual group.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Dyssomnias
Insomnia
Parasomnias
Sleep Disturbance
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT03918057
Study type	Interventional
Source	University of Calgary
Contact
Status	Completed
Phase	N/A
Start date	July 24, 2019
Completion date	January 30, 2022

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	`NCT06025968` - Digital Cognitive-behavioral Therapy for Insomnia for Patients With Multiple Sclerosis	N/A
Not yet recruiting	`NCT05991492` - Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.