Research on Expecting Moms and Sleep Therapy (REST)

University of California San Francisco (UCSF)

Status: Completed

Conditions: Insomnia

Treatments: Other: Treatment as Usual; Behavioral: Web-based CBT-I

Study type: Interventional

Funder types: Other

Identifiers

NCT02805998

16-19537

Details and patient eligibility

About

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).

Full 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.

Enrollment: 208 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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,

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Web-based CBT-I

Experimental group

Description:

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).

Treatment:

Behavioral: Web-based CBT-I

Other: Treatment as Usual

Treatment as Usual

Other group

Description:

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.

Treatment:

Other: Treatment as Usual