Research on Expecting Moms and Sleep Therapy

Depression in pregnancy ("antenatal depression") is common and associated with acute and
long-lasting adverse consequences for women and offspring. Insomnia is a risk factor for
depression in general populations, and poor sleep quality is linked to increased depression
among antenatal women. There have been no randomized control trials investigating
nonpharmacological insomnia treatment on antenatal insomnia and depression outcomes. Many
pregnant women use the Internet to seek pregnancy-related information, and report a
preference for mental health care within the home or obstetrics clinic. The overarching goal
is to utilize a randomized control design to examine efficacy of web-based cognitive behavior
therapy for insomnia and depression outcomes (CBT-I) compared to treatment as usual (TAU)
among pregnant women at risk for depression (n=208). Participants will be recruited
nationally to complete study questionnaires at five timepoints through pregnancy and 6 months
postpartum. Participants randomized to CBT-I will receive access to 6 weekly CBT-I
web-sessions and treatment as usual. Participants randomized to treatment as usual will
receive usual care and will be given access to Sleepio upon study completion. Our specific
aims are:

1. To evaluate feasibility and acceptability of CBT-I for pregnant women.

2. To test whether participants receiving CBT-I show improvement in sleep compared to TAU
participants.

3. To examine whether participants randomized to CBT-I will experience improved depressive
outcomes compared to TAU.

4. To explore the impact of CBT-I on birth outcomes.

There is strong conceptual basis to predict the potential benefit of this approach for
pregnant women. Targeting risk factors for antenatal depression may have significant public
health benefits.

Inclusion Criteria:

1. pregnant up to 28 weeks gestation,

2. 18 years of age or older,

3. Meets DSM-5 criteria for Insomnia disorder as determined by the Sleep Condition
Indicator or ISI ≥ 11

4. regular access to a web-enabled computer, tablet, or smart phone.

Exclusion Criteria:

1. Probable major depression (EPDS ≥ 15),

2. self-reported bipolar disorder,

3. self-reported history of psychosis,

4. active suicidality defined as scoring > 1 on EPDS item 10 or report of a specific
suicide plan or recent attempt,

5. shift work employee,