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
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Behavioral: Web-based CBT-I Other: Treatment as Usual||Not Applicable|
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:
- To evaluate feasibility and acceptability of CBT-I for pregnant women.
- To test whether participants receiving CBT-I show improvement in sleep compared to TAU participants.
- To examine whether participants randomized to CBT-I will experience improved depressive outcomes compared to TAU.
- 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 (Clinical Trial)|
|Estimated Enrollment :||208 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Change in Insomnia Severity Index Scale score [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
- Change in sleep efficiency, as determined by daily sleep logs [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
- Change in sleep duration, as determined by daily sleep logs [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
- 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 ]
- 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 ]
- Change in insomnia diagnosis, as determined by Sleep Condition Indicator [ Time Frame: Baseline to post-intervention, an anticipated average of 8 weeks ]
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
|United States, California|
|San Francisco, California, United States, 94118|
|Principal Investigator:||Jennifer N Felder, PhD||University of California, San Francisco|