Self-Management of Chronic Depressive Symptoms in Pregnancy

NCT ID: NCT02953990

Last Updated: 2024-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-02-12

Brief Summary

This study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. This line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child outcomes. Ultimately, this will contribute to the development and implementation of theoretically driven depression prevention/ resiliency building interventions and measurement of appropriate biobehavioral outcomes to determine the effectiveness of interventions.

Detailed Description

The investigators longitudinal mixed-methods study will use a one-group repeated measures intervention design coupled with qualitative methods to provide a comprehensive view of the feasibility, acceptability, and preliminary effects of the MOMS intervention. Semi-structured interviews, recruitment and retention numbers, and participant logs will be used to evaluate feasibility and acceptability of the intervention (Specific Aim 1). Recently collected archival comparison group data from an existing study will be used to contribute to explorations of preliminary effects of the intervention by comparing longitudinal psychobehavioral data, birth weight data (Specific Aims 2 and 3).

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MOMS Program

The MOMS Program involves: (1) mindfulness of symptoms and goal-setting through a nurse-participant partnership, and (2) 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home activity. Participants will engage in 12 weeks of weekly community-based group prenatal yoga classes (75 minutes each) and self-directed home practice.

Group Type: EXPERIMENTAL

MOMS Program

Intervention Type: BEHAVIORAL

Interventions

MOMS Program

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ age 18;
• self-report of depressive symptoms prior to pregnancy;
• current depressive symptoms at a moderate-to-severe level, as defined by a score ≥10 on the Patient Health Questionnaire-9;
• able to read, write, and understand English;
• self-identify as black/African American (AA) or White;
• absence of suicidal ideations (measured as low risk on the M.I.N.I. Neuropsychiatric Interview tool);
• absence of pregnancy complications/physical conditions making physical activity (PA) inadvisable;
• has not engaged in a consistent mindfulness-based PA routine during the pregnancy (such as yoga or similar activities more than once per month).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patricia A Kinser, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University School of Nursing

Richmond, Virginia, United States

Countries

United States

References

Kinser PA, Thacker LR, Rider A, Moyer S, Amstadter AB, Mazzeo SE, Bodnar-Deren S, Starkweather A. Feasibility, Acceptability, and Preliminary Effects of "Mindful Moms": A Mindful Physical Activity Intervention for Pregnant Women with Depression. Nurs Res. 2021 Mar-Apr 01;70(2):95-105. doi: 10.1097/NNR.0000000000000485.

Reference Type: DERIVED

PMID: 33630532 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R15HD086835-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20006941

Identifier Type: -

Identifier Source: org_study_id