Clinical trial NCT04016428: Online Prenatal Trial in Mindfulness Sleep Management
Official title: Online Prenatal Trial in Mindfulness Sleep Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Insomnia
Depression
Keywords: sleep
pregnancy
insomnia
depression
mindfulness
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-07-11
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Enrollment to intervention completion (6 weeks)
Secondary outcomes:
measure: Sleep efficiency
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Total wake time
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Total sleep time
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: PROMIS Sleep-Related Impairment Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: PROMIS Fatigue Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Enrollment to intervention completion (6 weeks)
measure: PROMIS Depression Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: PROMIS Anxiety Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Neuro-QOL Positive Affect and Well-Being Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Short Form (36) Health Survey
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Intervention adherence
timeFrame: Intervention completion (6 weeks)
measure: Meditation adherence
timeFrame: Intervention completion (6 weeks)
measure: Intervention acceptability
timeFrame: Intervention completion (6 weeks)
Other outcomes:
measure: PROMIS Self-Efficacy for Managing Emotions -- Short Form
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Index of Self-Regulation (ISR)
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Sleep Problem Acceptance Questionnaire (SPAQ)
timeFrame: Enrollment to intervention completion (6 weeks)
measure: Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
timeFrame: Enrollment to intervention completion (6 weeks)
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Ira Kantrowitz-Gordon, PhD, CNM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kantrowitz-Gordon I, McCurry SM, Landis CA, Lee R, Wi D. Online prenatal trial in mindfulness sleep management (OPTIMISM): protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2020 Sep 14;6:128. doi: 10.1186/s40814-020-00675-1. eCollection 2020.