Research on Expecting Moms and Sleep Therapy

Insomnia Clinical Trial

— REST  

Official title:

Research on Expecting Moms and Sleep Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02805998
• Other study ID #: 16-19537
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: May 2019

Study information

• Verified date: August 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: May 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• Web-based CBT-I

Other:
• Treatment as Usual

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Insomnia Severity Index Scale score		Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in sleep efficiency, as determined by daily sleep logs		Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in sleep duration, as determined by daily sleep logs		Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in global sleep quality, as determined by Pittsburgh Sleep Quality Index score		Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in depression symptom severity, as determined by Edinburg Postnatal Depression Scale score		Baseline to post-intervention, an anticipated average of 8 weeks
Secondary	Change in insomnia diagnosis, as determined by Sleep Condition Indicator		Baseline to post-intervention, an anticipated average of 8 weeks