Research on Expecting Moms and Sleep Therapy (REST)

June 20, 2024 updated by: University of California, San Francisco
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94118
        • UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. pregnant up to 28 weeks gestation,
  2. 18 years of age or older,
  3. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Insomnia disorder as determined by the Sleep Condition Indicator (SCI) or Insomnia Severity Index (ISI) score ≥ 11
  4. regular access to a web-enabled computer, tablet, or smart phone.

Exclusion Criteria:

  1. Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Treatment as Usual
Our control condition was designed to reflect standard care for insomnia patients. No limits are placed on receiving non-study treatment, including medication or psychotherapy. Use of non-study treatment will be tracked.
Other: Treatment as Usual
Experimental: Web-based CBT-I
Sleepio delivers CBT-I through 6 weekly web-sessions. Treatment content is based on CBT for insomnia manuals and includes a behavioral component (sleep restriction, stimulus control, and relaxation), a cognitive component (paradoxical intention, cognitive restructuring, mindfulness, positive imagery, putting the day to rest) and an educational component (psycho-education, sleep hygiene).
Other: Treatment as Usual
Behavioral: Web-based CBT-I

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Insomnia Severity Index Scale Score
Time Frame: Baseline to post-intervention (10 weeks post-randomization)
Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia.
Baseline to post-intervention (10 weeks post-randomization)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs
Time Frame: Baseline to post-intervention, an average of 8 weeks
Daily sleep diaries were used to measure percentage of sleep efficiency. Percentage of sleep efficiency was calculated by dividing the amount of time sleeping by the amount of time spent in bed. Sleep efficiency ranges from 0 to 100 percent, with higher scores indicating better outcomes.
Baseline to post-intervention, an average of 8 weeks
Change in Sleep Duration, as Determined by Daily Sleep Logs
Time Frame: Baseline to post-intervention, an average of 8 weeks
Daily sleep diaries were used to measure sleep duration. Greater sleep duration indicates a better outcome.
Baseline to post-intervention, an average of 8 weeks
Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score
Time Frame: Baseline to post-intervention, an average of 8 weeks
Global sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Scores range from 0 to 21, with higher scores indicating worse global sleep quality.
Baseline to post-intervention, an average of 8 weeks
Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score
Time Frame: Baseline to post-intervention, an average of 8 weeks
Depressive symptom severity was assessed using the Edinburgh Postnatal Depression Scale (EDPS). Scores on the EPDS range from 0 to 30, with higher scores indicating greater depressive symptom severity.
Baseline to post-intervention, an average of 8 weeks
Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator
Time Frame: Baseline to post-intervention, an average of 8 weeks
Insomnia caseness (i.e., whether a participant met the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition criteria for insomnia disorder) was assessed by the Sleep Condition Indicator (SCI), which is an eight-item rating scale to screen for an insomnia diagnosis. Scores range 0-32 with higher numbers indicating better sleep quality. Participants who scored below the cutoff were defined as having insomnia caseness (≤16). The mean indicates the direction and magnitude of the preponderance of changes in that direction. That is, negative values of the mean indicate that there were more changes from a baseline SCI value between 17 and 32 to a post-intervention SCI value between 1 and 16 than changes in the other direction.
Baseline to post-intervention, an average of 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Jennifer N Felder, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

June 7, 2016

First Submitted That Met QC Criteria

June 17, 2016

First Posted (Estimated)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 20, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 16-19537

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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