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Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression (MaMiDaPP)

Primary Purpose

Depression, Unipolar, Pain, Postoperative

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Mindfulness

About this trial

This is an interventional treatment trial for Depression, Unipolar focused on measuring postpartum, depression, pain, cesarean

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

18-45 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

Exclusion Criteria:

Women who screen 10 or higher on the EPDS

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mindfulness

Treatment as usual with monitoring

Arm Description

Receiving mobile, self-guided mindfulness intervention

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

Outcomes

Primary Outcome Measures

Postpartum depression

depressive symptoms EPDS 13 or higher

Secondary Outcome Measures

Post-operative pain

Post-cesarean delivery pain

Full Information

NCT ID

NCT05400382

First Posted

May 27, 2022

Last Updated

May 27, 2022

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

University of Pittsburgh Medical Center, Southern Illinois University, Arrowhead Regional Medical Center, Northwestern University Feinberg School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT05400382

Brief Title

Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

Acronym

MaMiDaPP

Official Title

Optimizing Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 1, 2023 (Anticipated)

Primary Completion Date

March 31, 2026 (Anticipated)

Study Completion Date

March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Illinois at Urbana-Champaign

Collaborators

University of Pittsburgh Medical Center, Southern Illinois University, Arrowhead Regional Medical Center, Northwestern University Feinberg School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression, Unipolar, Pain, Postoperative

Keywords

postpartum, depression, pain, cesarean

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness

Arm Type

Experimental

Arm Description

Receiving mobile, self-guided mindfulness intervention

Arm Title

Treatment as usual with monitoring

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness

Other Intervention Name(s)

Mindfulness meditation

Intervention Description

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

Primary Outcome Measure Information:

Title

Postpartum depression

Description

depressive symptoms EPDS 13 or higher

Time Frame

4 weeks - 6 months

Secondary Outcome Measure Information:

Title

Post-operative pain

Description

Post-cesarean delivery pain

Time Frame

4 weeks - 6 months

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Cis-gender women

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18-45 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 Exclusion Criteria: Women who screen 10 or higher on the EPDS

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sandraluz Lara-Cinisomo, Ph.D.

Phone

217-300-3512

laracini@illinois.edu

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

To be determined

Learn more about this trial

Mindfulness to Reduce Post-cesarean Pain and Prevent Postpartum Depression

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