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

Sponsor

University of Illinois at Urbana-Champaign (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05400382

Collaborator

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

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression, Unipolar Pain, Postoperative	Behavioral: Mindfulness	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

75 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Mar 31, 2026

Anticipated Study Completion Date :

Mar 31, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Receiving mobile, self-guided mindfulness intervention	Behavioral: Mindfulness Meditation training to help reduce stress and reactivity to pain and other stressors. Other Names: Mindfulness meditation
No Intervention: Treatment as usual with monitoring Receiving treatment as usual with monitoring by study PI and investigators.

Arm

Intervention/Treatment

Experimental: Mindfulness

Receiving mobile, self-guided mindfulness intervention

Behavioral: Mindfulness

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

Other Names:

Mindfulness meditation

No Intervention: Treatment as usual with monitoring

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

Outcome Measures

Primary Outcome Measures

Postpartum depression [4 weeks - 6 months]
depressive symptoms EPDS 13 or higher

Secondary Outcome Measures

Post-operative pain [4 weeks - 6 months]
Post-cesarean delivery pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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