Online Prenatal Trial in Mindfulness Sleep Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2021-06-30

Brief Summary

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The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.

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Detailed Description

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The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy.

There will be two groups:

1. An online mindfulness intervention for pregnant women (6 weeks) that focuses on behaviors to overcome sleep difficulties in pregnancy.
2. An online control group that will receive information about sleep in pregnancy (6 weeks).

Each group will be composed of 25 participants with a total sample of 50. The principal hypothesis is that the mindfulness intervention will be more effective than sleep education in the improvement of sleep and depression symptoms during pregnancy.

The differences between the intervention and control group will be analyzed. The acceptability and usability of online content will also be assessed.

Conditions

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Pregnancy Related Insomnia Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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OPTIMISM Intervention

Participants will receive online delivery of a mindfulness-based program for improving sleep in pregnancy, along with the usual care they would receive from their provider.

Group Type EXPERIMENTAL

OPTIMISM

Intervention Type BEHAVIORAL

Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.

Sleep Education

Participants will receive online delivery of an education program on sleep in pregnancy, along with the usual care they would receive from their provider.

Group Type ACTIVE_COMPARATOR

Sleep Education

Intervention Type BEHAVIORAL

Six-week online program that provides education on sleep during pregnancy.

Interventions

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OPTIMISM

Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.

Intervention Type BEHAVIORAL

Sleep Education

Six-week online program that provides education on sleep during pregnancy.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1\) Viable pregnancy in second trimester (up to 28 weeks gestation); 2) prior diagnosis of depression currently in remission (score \< 3 on the Patient Health Questionnaire (PHQ-2) depression screening questionnaire); 3) subjective report of insomnia (score \> 7 on the Insomnia Severity Index); 4) age 18 or older; 5) access to an Internet-enabled smartphone, tablet, or computer; and 6) English fluency. Participants will not be excluded from participation if they are currently receiving psychotropic medications or psychotherapy.

Exclusion Criteria

1\) Known severe congenital fetal anomalies, fetal demise, or expected neonatal death; 2) diagnosis of major depressive disorder within past 2 months; 3) other significant psychiatric illness requiring treatment; 4) current hospitalization; 5) prior diagnosis of obstructive sleep apnea or restless leg syndrome; 6) positive self-report screen for restless leg syndrome; 7) regular mindfulness or meditative practice (at least weekly); and 8) regular night-shift work.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No