Self-Management of Chronic Depressive Symptoms in Pregnancy

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Depression

Treatments: Behavioral: MOMS Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02953990

1R15HD086835-01A1 (U.S. NIH Grant/Contract)

HM20006941

Details and patient eligibility

About

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.

Full 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).

Enrollment: 41 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Exclusion criteria

• If individual does not meet the inclusion criteria listed above, they are ineligible for the study.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 1 patient group

MOMS Program

Experimental group

Description:

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.

Treatment:

Behavioral: MOMS Program