Trial Outcomes & Findings for Research on Expecting Moms and Sleep Therapy (NCT NCT02805998)

Last Updated: 2024-06-25

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

208 participants

Primary outcome timeframe

Baseline to post-intervention (10 weeks post-randomization)

Results posted on

2024-06-25

Participant Flow

Participant milestones

Participant milestones
Measure	Web-based CBT-I Sleepio delivers cognitive behavior therapy for insomnia (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	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
Overall Study STARTED	105	103
Overall Study COMPLETED	91	94
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Research on Expecting Moms and Sleep Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Web-based CBT-I n=105 Participants 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	Treatment as Usual n=103 Participants 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	Total n=208 Participants Total of all reporting groups
Age, Continuous	33.9 years STANDARD_DEVIATION 3.38 • n=5 Participants	33.2 years STANDARD_DEVIATION 4.0 • n=7 Participants	33.6 years STANDARD_DEVIATION 3.7 • n=5 Participants
Sex: Female, Male Female	105 Participants n=5 Participants	103 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic	100 Participants n=5 Participants	93 Participants n=7 Participants	193 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	5 Participants n=5 Participants	10 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	105 participants n=5 Participants	103 participants n=7 Participants	208 participants n=5 Participants
Gestational age at screening	17.1 weeks STANDARD_DEVIATION 6.4 • n=5 Participants	18.07 weeks STANDARD_DEVIATION 6.3 • n=7 Participants	17.6 weeks STANDARD_DEVIATION 6.3 • n=5 Participants
Income greater than or equal to 100,000 dollars	71 Participants n=5 Participants	70 Participants n=7 Participants	141 Participants n=5 Participants
Married or cohabitating	100 Participants n=5 Participants	96 Participants n=7 Participants	196 Participants n=5 Participants
Primiparous	46 Participants n=5 Participants	66 Participants n=7 Participants	112 Participants n=5 Participants
Insomnia symptom severity	14.52 units on a scale STANDARD_DEVIATION 3.26 • n=5 Participants	14.19 units on a scale STANDARD_DEVIATION 3.72 • n=7 Participants	14.36 units on a scale STANDARD_DEVIATION 3.49 • n=5 Participants
Percentage of sleep efficiency	72.22 percentage STANDARD_DEVIATION 12.35 • n=5 Participants	74.19 percentage STANDARD_DEVIATION 11.96 • n=7 Participants	73.20 percentage STANDARD_DEVIATION 12.17 • n=5 Participants
Nightly sleep duration	6.68 hours STANDARD_DEVIATION 1.13 • n=5 Participants	6.84 hours STANDARD_DEVIATION 1.23 • n=7 Participants	6.76 hours STANDARD_DEVIATION 1.18 • n=5 Participants
Global sleep quality	9.52 units on a scale STANDARD_DEVIATION 2.74 • n=5 Participants	9.47 units on a scale STANDARD_DEVIATION 3.02 • n=7 Participants	9.50 units on a scale STANDARD_DEVIATION 2.87 • n=5 Participants
Insomnia caseness	54 Participants n=5 Participants	41 Participants n=7 Participants	95 Participants n=5 Participants
Depressive symptom severity	7.79 units on a scale STANDARD_DEVIATION 4.05 • n=5 Participants	7.24 units on a scale STANDARD_DEVIATION 3.77 • n=7 Participants	7.52 units on a scale STANDARD_DEVIATION 3.91 • n=5 Participants
Anxiety symptom severity	5.43 units on a scale STANDARD_DEVIATION 3.55 • n=5 Participants	4.81 units on a scale STANDARD_DEVIATION 3.23 • n=7 Participants	5.12 units on a scale STANDARD_DEVIATION 3.40 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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