Clinical trial NCT02805998: Research on Expecting Moms and Sleep Therapy
Official title: Research on Expecting Moms and Sleep Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 208
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. pregnant up to 28 weeks gestation,
2. 18 years of age or older,
3. 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
4. regular access to a web-enabled computer, tablet, or smart phone.

Exclusion Criteria:

1. Probable major depression (Edinburgh Postnatal Depression Scale (EPDS) score ≥ 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,

Primary outcomes:
measure: Change in Insomnia Severity Index Scale Score
timeFrame: Baseline to post-intervention (10 weeks post-randomization)
Secondary outcomes:
measure: Change in Percentage of Sleep Efficiency, as Determined by Daily Sleep Logs
timeFrame: Baseline to post-intervention, an average of 8 weeks
measure: Change in Sleep Duration, as Determined by Daily Sleep Logs
timeFrame: Baseline to post-intervention, an average of 8 weeks
measure: Change in Global Sleep Quality, as Determined by Pittsburgh Sleep Quality Index Score
timeFrame: Baseline to post-intervention, an average of 8 weeks
measure: Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score
timeFrame: Baseline to post-intervention, an average of 8 weeks
measure: Change in Insomnia Diagnosis, as Determined by Sleep Condition Indicator
timeFrame: Baseline to post-intervention, an average of 8 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jennifer N Felder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Randomized controlled trial of digital cognitive behavior therapy for prenatal insomnia symptoms: effects on postpartum insomnia and mental health. Sleep. 2022 Feb 14;45(2):zsab280. doi: 10.1093/sleep/zsab280.
citation: Felder JN, Epel ES, Neuhaus J, Krystal AD, Prather AA. Efficacy of Digital Cognitive Behavioral Therapy for the Treatment of Insomnia Symptoms Among Pregnant Women: A Randomized Clinical Trial. JAMA Psychiatry. 2020 May 1;77(5):484-492. doi: 10.1001/jamapsychiatry.2019.4491.