Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Study Overview
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Brief Summary
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This study will evaluate the effect of a simplified behavioral relaxation intervention to improve insomnia in pregnant women

Detailed Description
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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.

Official Title
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Behavioral Relaxation Approaches for Insomnia in Pregnant Patients

Conditions
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Sleep Initiation and Maintenance Disorders, Pregnancy Related

Intervention / Treatment
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* Behavioral: Assisted Therapy
* Behavioral: Sleep Hygiene


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleep Hygiene<br>This arm will receive behavioral education, such as sleep hygiene and other advice. Additional details cannot be provided since that will compromise the participant blinding | Behavioral: Sleep Hygiene<br>* Standard Sleep Hygiene instructions.<br>|
| Experimental: ART and Sleep Hygiene<br>This arm will receive behavioral education, such as sleep hygiene and other training. Additional details cannot be provided since that will compromise the participant blinding | Behavioral: Assisted Therapy<br>* The participant will receive coaching calls and support<br>Behavioral: Sleep Hygiene<br>* Standard Sleep Hygiene instructions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSQI, Sleep Quality | 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). | 30 days | 
| Total Wake Time, Sleep Diary | 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. | 30 days |