Self-Management of Chronic Depressive Symptoms in Pregnancy

NCT02953990 | Completed Results DMC

• 2 other identifiers: HM200069411R15HD086835-01A1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Pregnancy; Self-Management; Yoga

Outcome Measures

Primary Outcomes (5)

• Recruitment Data

  \# individuals who enrolled in study/ # individuals who expressed interest in the study

  baseline

• Retention Data

  \# of participants enrolled/ # of participants completing study

  18 weeks post-baseline

• Adherence

  Measure of those who attended at least 50% of the yoga sessions (measured analyzing class rosters)

  End of 12 week intervention

• Completed Interviews

  The number of participants who completed the intervention and completed a postpartum semi-structured interview

  End of 6 week postpartum visit

• Edinburgh Postnatal Depression Scale (EPDS)

  Pregnancy-specific Depressive Symptoms/Perinatal-specific depressive symptoms were measured by the 10-item Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987); scores range from0 to 30, and a score of≥10 is considered indicative of possible depressive symptoms.

  baseline and end of 12 week intervention

Secondary Outcomes (8)

• Patient Health Questionnaire-9 (PHQ9)

  baseline and end of 12 week intervention

• State-Trait Anxiety Inventory-State (STAI-S)

  baseline and at the end of the 12 week intervention

• Ruminations Response Scale (RRS-10)

  baseline and at the end of the 12 week intervention

• Self-Efficacy for Physical Activity

  Baseline visit to end of 12 week intervention visit

• Maternal Fetal Attachment Scale (MFAS)

  baseline and at the end of the 12 week intervention

Study Arms (1)

MOMS Program

EXPERIMENTAL

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.

Behavioral: MOMS Program

Interventions

MOMS Program BEHAVIORAL

MOMS Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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).

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Virginia Commonwealth University School of Nursing

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

• 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.

  PMID: 33630532 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Patricia Kinser, PI
• Organization: Virginia Commonwealth University School of Nursing

kinserpa@vcu.edu

804-828-0724

Study Officials

• Patricia A Kinser, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 3, 2016
• Study Start: September 1, 2016
• Primary Completion: February 12, 2019
• Study Completion: February 12, 2019
• Last Updated: March 25, 2024
• Results First Posted: March 25, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)