Clinical trial NCT02953990: Self-Management of Chronic Depressive Symptoms in Pregnancy
Official title: Self-Management of Chronic Depressive Symptoms in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Pregnancy
Self-Management
Yoga
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-11-03
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).

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).

Exclusion Criteria:

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

Primary outcomes:
measure: Recruitment Data
timeFrame: baseline
measure: Retention Data
timeFrame: 18 weeks post-baseline
measure: Adherence
timeFrame: End of 12 week intervention
measure: Completed Interviews
timeFrame: End of 6 week postpartum visit
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: baseline and end of 12 week intervention
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ9)
timeFrame: baseline and end of 12 week intervention
measure: State-Trait Anxiety Inventory-State (STAI-S)
timeFrame: baseline and at the end of the 12 week intervention
measure: Ruminations Response Scale (RRS-10)
timeFrame: baseline and at the end of the 12 week intervention
measure: Self-Efficacy for Physical Activity
timeFrame: Baseline visit to end of 12 week intervention visit
measure: Maternal Fetal Attachment Scale (MFAS)
timeFrame: baseline and at the end of the 12 week intervention
measure: Baby's Birth Weight
timeFrame: postpartum visit
measure: Stress
timeFrame: Change from Baseline visit to end of 12 week intervention visit
measure: Total # of Minutes in Physical Activity (Including Yoga)
timeFrame: End of 12 week intervention
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University School of Nursing
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Patricia A Kinser, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.