Pregnancy Related, Sleep Initiation and Maintenance Disorders
Conditions
Brief summary
This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women
Detailed description
This is a randomized, 60-day research study that is evaluating the effect of a simplified behavioral relaxation intervention in pregnant and postpartum patients aimed to improve their insomnia symptoms. The investigators will be enrolling a total of 20 patients who indicate self-reported insomnia symptoms.
Interventions
BEHAVIORALAssisted Therapy
The participant will receive coaching calls and support
BEHAVIORALSleep Hygiene
Standard Sleep Hygiene instructions.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 55 * In second or third trimester of pregnancy (Gestation weeks 18-32) * Able to speak, read and write fluent English * Has regular access to a smartphone and/or smart tablet * sleep onset latency (SOL) or nocturnal awakening need be 30 min or more for ≥3 nights/week, must persist for at least 1 month
Exclusion criteria
* Participants with fixed night shift work between midnight and 5 am, or rotating work schedules requiring night shifts during the study period. * Medical or other factors that, in the opinion of the study research team, would interfere with their ability to participate in the intervention (such as inability to participate in the ART due to blindness)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSQI, Sleep Quality | 30 days | Measured by a single item score, sleep quality is the measurement of how restful and restorative the sleep of an individual is. Pittsburgh Sleep Quality Index: Well- known questionnaire used to measure sleep quality in various patient groups. For overall sleep quality, the minimum score= 0 (better) and the maximum score=3 (worse). |
| Total Wake Time, Sleep Diary | 30 days | A sleep diary will be used to gather information about the participants daily sleep pattern and schedule; gold standard of care for insomnia. This instrument will also be used to check adherence to the Gratification practice of the ART intervention. This will be administered during pre-screening and intervention. |
Countries
United States
Outcome results
None listed