Research on Expecting Moms and Sleep Therapy

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02805998

Acronym

REST

Enrollment

208

Registered

2016-06-20

Start date

2016-10-31

Completion date

2019-05-31

Last updated

2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

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.

Interventions

BEHAVIORALWeb-based CBT-I

OTHERTreatment as Usual

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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,

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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). Web-based CBT-I Treatment as Usual	105
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. Treatment as Usual	103
Total	208

Baseline characteristics

Characteristic	Web-based CBT-I	Treatment as Usual	Total
Age, Continuous	33.9 years STANDARD_DEVIATION 3.38	33.2 years STANDARD_DEVIATION 4	33.6 years STANDARD_DEVIATION 3.7
Anxiety symptom severity	5.43 units on a scale STANDARD_DEVIATION 3.55	4.81 units on a scale STANDARD_DEVIATION 3.23	5.12 units on a scale STANDARD_DEVIATION 3.4
Depressive symptom severity	7.79 units on a scale STANDARD_DEVIATION 4.05	7.24 units on a scale STANDARD_DEVIATION 3.77	7.52 units on a scale STANDARD_DEVIATION 3.91
Gestational age at screening	17.1 weeks STANDARD_DEVIATION 6.4	18.07 weeks STANDARD_DEVIATION 6.3	17.6 weeks STANDARD_DEVIATION 6.3
Global sleep quality	9.52 units on a scale STANDARD_DEVIATION 2.74	9.47 units on a scale STANDARD_DEVIATION 3.02	9.50 units on a scale STANDARD_DEVIATION 2.87
Income greater than or equal to 100,000 dollars	71 Participants	70 Participants	141 Participants
Insomnia caseness	54 Participants	41 Participants	95 Participants
Insomnia symptom severity	14.52 units on a scale STANDARD_DEVIATION 3.26	14.19 units on a scale STANDARD_DEVIATION 3.72	14.36 units on a scale STANDARD_DEVIATION 3.49
Married or cohabitating	100 Participants	96 Participants	196 Participants
Nightly sleep duration	6.68 hours STANDARD_DEVIATION 1.13	6.84 hours STANDARD_DEVIATION 1.23	6.76 hours STANDARD_DEVIATION 1.18
Percentage of sleep efficiency	72.22 percentage STANDARD_DEVIATION 12.35	74.19 percentage STANDARD_DEVIATION 11.96	73.20 percentage STANDARD_DEVIATION 12.17
Primiparous	46 Participants	66 Participants	112 Participants
Race/Ethnicity, Customized Hispanic	5 Participants	10 Participants	15 Participants
Race/Ethnicity, Customized Not Hispanic	100 Participants	93 Participants	193 Participants
Region of Enrollment United States	105 participants	103 participants	208 participants
Sex: Female, Male Female	105 Participants	103 Participants	208 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 105	0 / 103
other Total, other adverse events	3 / 105	3 / 103
serious Total, serious adverse events	0 / 105	0 / 103

Outcome results

Primary

Change in Insomnia Severity Index Scale Score

Insomnia Severity Index (ISI). Scores on the ISI range from 0 to 28, with higher scores indicating more severe insomnia.

Time frame: Baseline to post-intervention (10 weeks post-randomization)

Population: The number of participants analyzed is fewer than the number of participants who completed each arm of the study due to 23 participants being lost-to-follow up and not completing the ISI at post-intervention.

Arm	Measure	Value (MEAN)	Dispersion
Web-based CBT-I	Change in Insomnia Severity Index Scale Score	-6.054945 units on a scale	Standard Deviation 4.347062
Treatment as Usual	Change in Insomnia Severity Index Scale Score	-2.212766 units on a scale	Standard Deviation 4.699285

Secondary

Change in Depression Symptom Severity, as Determined by Edinburgh Postnatal Depression Scale Score

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.