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Completed

NCT Number: NCT02953990

Self-Management of Chronic Depressive Symptoms in Pregnancy

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University School of Nursing

Richmond, Virginia, 23298, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MOMS Program

Behavioral

Primary outcomes

  1. Recruitment Data

    Time frame: baseline

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

  2. Retention Data

    Time frame: 18 weeks post-baseline

    # of participants enrolled/ # of participants completing study

  3. Adherence

    Time frame: End of 12 week intervention

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

  4. 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

  5. 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.

Secondary outcomes

  1. Patient Health Questionnaire-9 (PHQ9)

    Time frame: baseline and end of 12 week intervention

    Depressive Symptoms/ Perceived stress was measured with the 10-item Perceived Stress Scale; scores range from 0 to 40, and higher scores represent higher perceived stress.

  2. State-Trait Anxiety Inventory-State (STAI-S)

    Time frame: baseline and at the end of the 12 week intervention

    State Anxiety/ Anxiety was measured with the State Anxiety Form Y ; scores range from20 to 80, and higher scores indicate higher state anxiety.

  3. Ruminations Response Scale (RRS-10)

    Time frame: baseline and at the end of the 12 week intervention

    Ruminations/ The Ruminative Responses Scale was used to measure ruminations; total scores range from 10 to 40, where higher scores indicate higher rumination.

  4. Self-Efficacy for Physical Activity

    Time frame: Baseline visit to end of 12 week intervention visit

    Self-Efficacy for Physical Activity: The Physical Activity Self-Efficacy Scale is an eight-question scale that contains items about self-management of physical activities and social support regarding physical activity. A higher score indicates higher self-efficacy. The scores may range form 0-90

  5. Maternal Fetal Attachment Scale (MFAS)

    Time frame: baseline and at the end of the 12 week intervention

    Maternal-Child Attachment/ Maternal-fetal/ child attachment was measured using the Maternal-Fetal Attachment Scale with wording adapted slightly for the postpartum use; scores range from 24 to 120,with higher scores indicating higher attachment.

  6. Baby's Birth Weight

    Time frame: postpartum visit

    Baby's birth weight in pounds per mother's report at postpartum visit

  7. Stress

    Time frame: Change from Baseline visit to end of 12 week intervention visit

    Perceived Stress Scale (PSS): 10-item scale; scores range from 0 to 40, and higher scores represent higher perceived stress

  8. Total # of Minutes in Physical Activity (Including Yoga)

    Time frame: End of 12 week intervention

    Adherence to physical activity aspect of intervention (including yoga)

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

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

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 3, 2016
Registry last updated
Mar 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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