NCT05400382

Brief Summary

This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

2.8 years

First QC Date

May 27, 2022

Last Update Submit

May 27, 2022

Conditions

Depression, UnipolarPain, Postoperative

Keywords

postpartumdepressionpaincesarean

Outcome Measures

Primary Outcomes (1)

  • Postpartum depression

    depressive symptoms EPDS 13 or higher

    4 weeks - 6 months

Secondary Outcomes (1)

  • Post-operative pain

    4 weeks - 6 months

Study Arms (2)

Mindfulness

EXPERIMENTAL

Receiving mobile, self-guided mindfulness intervention

Behavioral: Mindfulness

Treatment as usual with monitoring

NO INTERVENTION

Receiving treatment as usual with monitoring by study PI and investigators.

Interventions

MindfulnessBEHAVIORAL

Meditation training to help reduce stress and reactivity to pain and other stressors.

Also known as: Mindfulness meditation
Mindfulness

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsCis-gender women
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age, have a singleton pregnancy, score less than 10 on the Edinburgh Postnatal Depression Scale (EPDS; (Cox et al., 1987b), willing to participate in the eight-week intervention or be randomized to the TAUM condition, have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance use disorder, etc.), have no chronic pain condition (e.g., fibromyalgia), and proficient in English or Spanish

You may not qualify if:

  • Women who screen 10 or higher on the EPDS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive DisorderPain, PostoperativeDepressionPain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Sandraluz Lara-Cinisomo, Ph.D.

CONTACT

217-300-3512laracini@illinois.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

July 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

June 1, 2022

Record last verified: 2022-05