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Clinical Trials/NCT02953990
NCT02953990
Completed
Not Applicable

Self-Management of Chronic Depressive Symptoms in Pregnancy

Virginia Commonwealth University1 site in 1 country41 target enrollmentSeptember 2016
ConditionsDepression

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Virginia Commonwealth University
Enrollment
41
Locations
1
Primary Endpoint
Recruitment Data
Status
Completed
Last Updated
2 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2016
End Date
February 12, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Recruitment Data

Time Frame: baseline

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

Edinburgh Postnatal Depression Scale (EPDS)

Time Frame: baseline and end of 12 week intervention

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.

Adherence

Time Frame: End of 12 week intervention

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

Retention Data

Time Frame: 18 weeks post-baseline

# of participants enrolled/ # of participants completing study

Completed Interviews

Time Frame: End of 6 week postpartum visit

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

Secondary Outcomes

  • State-Trait Anxiety Inventory-State (STAI-S)(baseline and at the end of the 12 week intervention)
  • Self-Efficacy for Physical Activity(Baseline visit to end of 12 week intervention visit)
  • Stress(Change from Baseline visit to end of 12 week intervention visit)
  • Total # of Minutes in Physical Activity (Including Yoga)(End of 12 week intervention)
  • Patient Health Questionnaire-9 (PHQ9)(baseline and end of 12 week intervention)
  • Maternal Fetal Attachment Scale (MFAS)(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)
  • Baby's Birth Weight(postpartum visit)

Study Sites (1)

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