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Self-Management of Chronic Depressive Symptoms in Pregnancy

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ClinicalTrials.gov Identifier: NCT02953990
Recruitment Status : Completed
First Posted : November 3, 2016
Last Update Posted : February 19, 2019
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE October 31, 2016
First Posted Date  ICMJE November 3, 2016
Last Update Posted Date February 19, 2019
Study Start Date  ICMJE September 2016
Actual Primary Completion Date February 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • # individuals who enrolled in study/ # individuals who expressed interest in the study [ Time Frame: Through study completion ]
    Recruitment data
  • # of participants enrolled/ # of participants completing study [ Time Frame: Through study completion (end of 6-week postpartum visit) ]
    Retention data
  • total # of minutes of yoga [ Time Frame: End of 12 week intervention ]
    Adherence to yoga aspect of intervention
  • Semi-structured qualitative interviews [ Time Frame: End of 6 week postpartum visit ]
    Participant satisfaction data
  • Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Pregnancy-specific Depressive Symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • # individuals who enrolled in study/ # individuals who expressed interest in the study [ Time Frame: Through study completion ]
    Recruitment data
  • # of participants enrolled/ # of participants completing study [ Time Frame: Through study completion (end of 6-week postpartum visit) ]
    Retention data
  • total # of minutes of yoga [ Time Frame: End of 12 week intervention ]
    Adherence to yoga aspect of intervention
  • Semi-structured qualitative interviews [ Time Frame: End of 6 week postpartum visit ]
    Participant satisfaction data
  • Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Pregnancy-specific Depressive Symptoms
Change History Complete list of historical versions of study NCT02953990 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
  • Patient Health Questionnaire-9 (PHQ9) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Depressive Symptoms
  • State-Trait Anxiety Inventory-State (STAI-S) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    State Anxiety
  • Ruminations Response Scale (RRS-10) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Ruminations
  • Karitane Parenting Confidence Scale (KPCS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Parenting Self-Efficacy
  • Maternal Fetal Attachment Scale (MFAS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Maternal-Child Attachment
  • Baby's Birth Weight [ Time Frame: 6-week postpartum visit ]
    per mother's report at 6-week postpartum visit
  • Perceived Stress Scale (PSS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Stress
  • Physical Activity Self-Efficacy Scale (PASES) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Physical Activity Self-Efficacy
  • total # of minutes in physical activity (including yoga) [ Time Frame: End of 12 week intervention ]
    Adherence to physical activity aspect of intervention (including yoga)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
  • Patient Health Questionnaire-9 (PHQ9) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Depressive Symptoms
  • State-Trait Anxiety Inventory-State (STAI-S) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    State Anxiety
  • Ruminations Response Scale (RRS-10) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Ruminations
  • Karitane Parenting Confidence Scale (KPCS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Parenting Self-Efficacy
  • Maternal Fetal Attachment Scale (MFAS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Maternal-Child Attachment
  • Baby's Birth Weight [ Time Frame: 6-week postpartum visit ]
    per mother's report at 6-week postpartum visit
  • DNA methylation [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    genome-wide and gene-specific DNAm patterns (e.g., candidate genes putatively related to depression, pregnancy, and mindful interventions: Nr3c1, NGFI-A, FKBP5, BDNF, TrkB, HP1BP3, TTC9B)
  • Perceived Stress Scale (PSS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Stress
  • Physical Activity Self-Efficacy Scale (PASES) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit ]
    Physical Activity Self-Efficacy
  • total # of minutes in physical activity (including yoga) [ Time Frame: End of 12 week intervention ]
    Adherence to physical activity aspect of intervention (including yoga)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-Management of Chronic Depressive Symptoms in Pregnancy
Official Title  ICMJE Self-Management of Chronic Depressive Symptoms in Pregnancy
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Depression
Intervention  ICMJE Behavioral: MOMS Program
Study Arms  ICMJE Experimental: MOMS Program
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.
Intervention: Behavioral: MOMS Program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 12, 2019
Actual Primary Completion Date February 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953990
Other Study ID Numbers  ICMJE HM20006941
1R15HD086835-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Patricia A Kinser, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP