Research on Expecting Moms and Sleep Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Change in Insomnia Severity Index Scale Score
Study Overview
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).
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:
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •pregnant up to 28 weeks gestation,
- •18 years of age or older,
- •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
- •regular access to a web-enabled computer, tablet, or smart phone.
Exclusion Criteria
- •Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 15),
- •self-reported bipolar disorder,
- •self-reported history of psychosis,
- •active suicidality defined as scoring > 1 on EPDS item 10 or report of a specific suicide plan or recent attempt,
- •shift work employee,
Arms & Interventions
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).
Intervention: Web-based CBT-I (Behavioral)
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.
Intervention: Treatment as Usual (Other)
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).
Intervention: Treatment as Usual (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Sleep Duration, as Determined by Daily Sleep Logs(Baseline to post-intervention, an average of 8 weeks)
- Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs(Baseline to post-intervention, an average of 8 weeks)
- Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score(Baseline to post-intervention, an average of 8 weeks)
- Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score(Baseline to post-intervention, an average of 8 weeks)
- Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator(Baseline to post-intervention, an average of 8 weeks)