Evaluation of Digital Sleep Program to Improve Sleep Among New Parents
NCT ID: NCT07302893
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2026-01-15
2026-09-15
Brief Summary
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Cognitive Behavioral Therapy for Insomnia (CBT-I) is widely recognized as the gold standard treatment for chronic insomnia, demonstrating robust efficacy in diverse populations. However, its applicability in the postpartum period remains underexplored. New parents face a distinct set of sleep challenges, most notably, a significant loss of control over their sleep schedules due to infant care demands. This unpredictability complicates the implementation of core CBT-I techniques such as sleep restriction and stimulus control. Additionally, postpartum parents often experience heightened fatigue, limited time, and cognitive overload, potentially reducing their ability to engage with and retain behavioral or educational interventions.
This study addresses a significant gap in sleep health research by evaluating whether a modified digital CBT-I intervention, enhanced with brief meditation content, can improve self-reported sleep outcomes in new parents. By including both immediate (post-intervention) and longer-term (3-month follow-up) outcomes, the study aligns with broader public health goals of reducing mental health morbidity and improving functioning in the perinatal population.
The Headspace Health Sleep Program is an 18 day program based on CBT-I, which includes the following intervention components: 1) a sleep diary to monitor sleep and associated factors; 2) cognitive interventions to address maladaptive thoughts related to sleep; 3) behavioral interventions to address maladaptive behaviors related to sleep (e.g., sleep hygiene, stimulus control, and sleep restriction); 4) de-arousal techniques (e.g., mindfulness, breathing, and muscle relaxation exercises).
Detailed Description
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A set of outcome measures will be used to evaluate the Headspace Health Sleep Program vs. a waitlist control group. The Insomnia Severity Index (ISI) will be used as a primary outcome measure as well as the Sleep Diary. In addition, secondary outcome measures include Pittsburgh Sleep Quality Index (PSQI), Perceived Stress Scale (PSS-10) and General Anxiety Disorder-7 (GAD-7). Baseline measures will be taken prior to randomization, and at post-intervention. 3 months following the post-intervention assessment, participants will again be asked to report sleep quality using self-reported surveys.
Eligible participants will complete a one-week baseline assessment period during which they will be provided with a sleep diary. Each morning, they will receive a brief EMA prompt to record sleep-related information from the previous night. Following the 1-week baseline assessment period, participants will be asked to complete baseline questionnaires (i.e., ISI, PSQI, PSS-10, GAD7). They will then be randomized into one of two groups (Headspace Health Sleep Program or waitlist control). Having completed the intervention, participants will be scheduled for the 1-week post-intervention assessment period. Participants will again complete the sleep diary. At the end of this 1-week post-intervention assessment period, participants will complete questionnaires (i.e., ISI, PSQI, PSS-10, GAD7). 3 months following the post-intervention, participants will be asked to complete the sleep diary for a 1-week follow-up assessment period and in addition the ISI, PSQI, PSS-10, and GAD7.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Digital CBT-I recipients
instructed to follow the 18-session Headspace sleep program daily
Digital CBT-I
Headspace 18-session sleep program
No intervention
asked to maintain their regular routines
No interventions assigned to this group
Interventions
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Digital CBT-I
Headspace 18-session sleep program
Eligibility Criteria
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Inclusion Criteria
* Caregiver is over 18 years old
* Caregiver meets clinical threshold for insomnia (11 or greater on the ISI)
* Own a smartphone that can support downloaded apps
* Fluency in English
Exclusion Criteria
* Prior enrollment in another CBT-I program
* Regular mindfulness meditation practice
* Diagnosed sleep disordered breathing
* Parents of infants with health complications
18 Years
ALL
No
Sponsors
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Headspace
UNKNOWN
Udisense DBA Nanit
INDUSTRY
Responsible Party
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Locations
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Nanit office
New York, New York, United States
Countries
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Central Contacts
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Maristella Lucchini, Senior Clinical Researcher at Nanit, PhD
Role: CONTACT
Phone: 1-866-696-2648
Email: [email protected]
Facility Contacts
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Natalie Barnett, VP of Clinical Research at Nanit, PhD
Role: primary
Other Identifiers
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Nanit 2025-18
Identifier Type: -
Identifier Source: org_study_id