Digital CBT-I for Insomnia in New Parents
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a digital version of Cognitive Behavioral Therapy for Insomnia (CBT-I) to assist new parents with sleep issues. The goal is to determine if this digital program, which includes sleep tracking, helpful sleep habits, and relaxation exercises, can improve sleep for first-time parents of infants. Participants will either follow the program or continue their usual routines. The trial seeks first-time parents with infants aged 4-12 months who struggle with insomnia and have a smartphone. As an unphased trial, it provides a unique opportunity to explore innovative solutions for better sleep.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
What prior data suggests that this digital CBT-I is safe for new parents?
Research has shown that digital Cognitive Behavioral Therapy for Insomnia (CBT-I) is generally safe and well-tolerated. Studies have found that this therapy can improve sleep without causing major side effects. For instance, one study found that digital CBT-I helped many people sleep better and reduced their insomnia. Another study showed that those who used digital CBT-I were more likely to overcome insomnia and had fewer sleep problems later.
Most people using digital CBT-I do not report serious issues. Techniques like keeping sleep diaries and doing relaxation exercises are designed to help, not harm. Overall, this treatment seems safe for new parents struggling with sleep and offers a promising way to improve their sleep without major risks.12345Why are researchers excited about this trial?
Researchers are excited about Digital CBT-I for insomnia in new parents because it offers a unique, accessible approach to managing sleep issues. Unlike traditional therapies, which often involve in-person sessions, Digital CBT-I is delivered through an 18-session online program via Headspace, allowing parents to access help conveniently from home. This digital format not only fits seamlessly into the hectic schedules of new parents but also provides personalized support, which could lead to better adherence and outcomes compared to standard treatments like medication or face-to-face therapy.
What evidence suggests that digital CBT-I is effective for improving sleep in new parents?
Research has shown that digital cognitive behavioral therapy for insomnia (CBT-I) effectively treats sleep problems. Studies found that digital CBT-I helped more people overcome insomnia and improved their sleep quality. Pregnant individuals who used digital CBT-I reported better sleep and less anxiety after giving birth. A review of multiple studies confirmed that online CBT-I significantly improves sleep quality and reduces the time it takes to fall asleep. Overall, digital CBT-I is a safe and effective way to manage insomnia symptoms, even during challenging times like after childbirth. Participants in this trial will either receive the digital CBT-I intervention or maintain their regular routines without intervention.35678
Are You a Good Fit for This Trial?
This trial is for first-time parents with infants aged 4-12 months who are over 18 years old, experiencing insomnia (scoring 11 or more on the ISI), own a smartphone, and speak English fluently.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete a 1-week baseline assessment period with a sleep diary and baseline questionnaires
Treatment
Participants follow the 18-session Headspace Health Sleep Program or are placed in a waitlist control group
Post-intervention Assessment
Participants complete a 1-week post-intervention assessment period with a sleep diary and questionnaires
Follow-up
Participants are monitored for sleep quality and other outcomes 3 months after the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Digital CBT-I
Trial Overview
The study tests a digital CBT-I program from Headspace Health designed to improve sleep among new parents. It includes monitoring sleep patterns, cognitive and behavioral interventions, as well as de-arousal techniques like mindfulness.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
instructed to follow the 18-session Headspace sleep program daily
asked to maintain their regular routines
Find a Clinic Near You
Who Is Running the Clinical Trial?
Udisense DBA Nanit
Lead Sponsor
Headspace
Collaborator
Citations
Randomized controlled trial of digital cognitive behavior ...
Current findings suggest that digital cognitive behavior therapy for insomnia, when delivered during pregnancy, is associated with insomnia remission at 6 ...
Randomized controlled trial of cognitive behavioral therapy for ...
Felder et al, who tracked individuals longer-term, found that those who received digital CBTI had higher rates of insomnia remission and lower rates of insomnia ...
Cognitive Behavioral Therapy for Perinatal Insomnia
CBT-I initiated in pregnancy led to better sleep maintenance 1.5 months postpartum (Kalmbach et al., Citation2020), reduced insomnia, anxiety, ...
Internet-delivered cognitive behavioral therapy for insomnia
A meta-analysis by Robert Zachariae et al. confirmed that eCBT-I significantly improves insomnia severity, sleep efficiency, sleep quality, latency, and total ...
Efficacy of Digital Cognitive Behavioral Therapy for the ...
In this trial, digital CBT was an effective, scalable, safe, and acceptable intervention for improving insomnia symptoms during pregnancy.
A randomized controlled trial of digital cognitive behavioral ...
We hypothesized that pregnant patients receiving digital CBTI would report greater improvements in sleep (decreased insomnia symptoms, decreased sleep ...
Evaluation of Digital Sleep Program to Improve ...
The purpose of the study is to examine the effectiveness of the Headspace Health Sleep Program for improving subjective sleep quality (i.e., ...
Cognitive behavioural therapy for perinatal insomnia
Limited support found for CBT-I effectiveness on insomnia across postpartum stages. •. Larger effects were noted in late postpartum. •.
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