Research on Expecting Moms and Sleep Therapy

Not Applicable

Completed

Conditions: Insomnia

Interventions: Other: Treatment as Usual
Behavioral: Web-based CBT-I

Registration Number: NCT02805998

Lead Sponsor: 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).

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 208

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,

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Web-based CBT-I	Treatment as Usual	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).
Web-based CBT-I	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).

Primary Outcome Measures

Name	Time	Method
Change in Insomnia Severity Index Scale Score	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 Outcome Measures

Name	Time	Method
Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs	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.
Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score	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.
Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score	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.
Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator	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.
Change in Sleep Duration, as Determined by Daily Sleep Logs	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.