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Research on Expecting Moms and Sleep Therapy (REST)

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ClinicalTrials.gov Identifier: NCT02805998
Recruitment Status : Active, not recruiting
First Posted : June 20, 2016
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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).

Condition or disease Intervention/treatment Phase
Insomnia Behavioral: Web-based CBT-I Other: Treatment as Usual Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Research on Expecting Moms and Sleep Therapy
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: Web-based CBT-I
Sleepio delivers CBT-I through 6 weekly web-sessions (www.sleepio.com). Treatment content is based on CBT for insomnia manuals (Espie et al., 2007, 2008) 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).
Behavioral: Web-based CBT-I
Other: Treatment as Usual
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



Primary Outcome Measures :
  1. Change in Insomnia Severity Index Scale score [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]

Secondary Outcome Measures :
  1. Change in sleep efficiency, as determined by daily sleep logs [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
  2. Change in sleep duration, as determined by daily sleep logs [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
  3. Change in global sleep quality, as determined by Pittsburgh Sleep Quality Index score [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
  4. Change in depression symptom severity, as determined by Edinburg Postnatal Depression Scale score [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
  5. Change in insomnia diagnosis, as determined by Sleep Condition Indicator [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805998


Locations
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United States, California
UCSF
San Francisco, California, United States, 94118
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Jennifer N Felder, PhD University of California, San Francisco

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02805998     History of Changes
Other Study ID Numbers: 16-19537
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders