Anxiety & Depression Association of America

Perinatal Research on Improving Sleep and Mental Health

Purpose

The goal of this clinical trial is to compare two sleep programs in pregnant people with insomnia. The main questions it aims to answer are: 1. What is the efficacy of digital cognitive behavioral therapy for insomnia (CBT-I) versus digital sleep hygiene education (SHE) for preventing perinatal depression? 2. Is the effect of digital CBT-I on perinatal depression mediated through prenatal insomnia symptom improvement? 3. Is the effect of digital CBT-I on perinatal depression moderated by baseline depressive symptom severity? Participants will receive one of two sleep programs - SHE or CBT-I. Both involve six weekly online sessions. Participants will complete surveys and interviews until 1 year postpartum.

Conditions

Insomnia
Depression

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

Inclusion Criteria

Pregnant 14-28 weeks gestation - 18 years or older - Daily access to a web-enabled computer, smart phone, or tablet - Current elevated insomnia symptom severity and insomnia disorder - English speaking

Exclusion Criteria

Current major depression - Taking or planning to take antidepressant medication (ADM) - Other diagnosed or suspected sleep disorder - Other psychiatric or medical issues (e.g., bipolar disorder, active suicidality, bed rest) - Night shift worker

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Double (Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Digital cognitive behavior therapy for insomnia (CBT-I)		Device: Digital CBT-I The digital CBT-I program is called Sleepio (Big Health, Ltd). Digital CBT-I will be delivered by an animated therapist in six weekly sessions that are approximately 10-20 minutes each. Sessions can be accessed via website or app at a time that is convenient for the participant. Session content is based on standard, in-person CBT-I protocols, and includes sleep restriction, stimulus control, cognitive therapy, relaxation techniques, and sleep hygiene education. The program is interactive, automated, and tailored to participant progress. Additionally, participants will receive supplemental CBT-I content tailored for prenatal and postpartum insomnia. Other names: Sleepio
Active Comparator Digital sleep hygiene education (SHE)		Device: Digital SHE The digital SHE program was created by Big Health, Ltd and has a total of six sessions. The content for SHE includes education about sleep stages, sleep architecture, sleep cycles; education about importance of sleep for performance, mood, and health; recommendations for developing healthy sleep habits; recommendations for lifestyle factors that impact sleep; recommendations for creating a sleep-friendly bedroom.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of California, San Francisco

Study Contact

Jennifer N Felder, PhD
415-476-7014
jennifer.felder@ucsf.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.