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Eligibility
for females ages 18 years and up
Location
at San Francisco, California
Dates
study started
estimated completion:
Principal Investigator
Jennifer N Felder

Description

Summary

The overarching goal is to utilize a randomized control design to examine efficacy of web-based cognitive behavior therapy (CBT-I) plus treatment as usual compared to treatment as usual alone for insomnia and depression outcomes among pregnant women with insomnia at high risk for depressive relapse/recurrence (n=208).

Details

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.

Keywords

Insomnia

Eligibility

You can join if…

Open to females ages 18 years and up

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

You CAN'T join if...

  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,

Location

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT02805998
Lead Scientist
Jennifer N Felder
Study Type
Interventional
Last Updated
December 1, 2016
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