Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 83 of 2660 for:    "Depressive Disorder" [DISEASE] AND depressive symptoms

Self-Management of Chronic Depressive Symptoms in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: MOMS Program Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Self-Management of Chronic Depressive Symptoms in Pregnancy
Study Start Date : September 2016
Actual Primary Completion Date : February 12, 2019
Actual Study Completion Date : February 12, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Behavioral: MOMS Program



Primary Outcome Measures :
  1. # individuals who enrolled in study/ # individuals who expressed interest in the study [ Time Frame: Through study completion ]
    Recruitment data

  2. # of participants enrolled/ # of participants completing study [ Time Frame: Through study completion (end of 6-week postpartum visit) ]
    Retention data

  3. total # of minutes of yoga [ Time Frame: End of 12 week intervention ]
    Adherence to yoga aspect of intervention

  4. Semi-structured qualitative interviews [ Time Frame: End of 6 week postpartum visit ]
    Participant satisfaction data

  5. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Baby's Birth Weight [ Time Frame: 6-week postpartum visit ]
    per mother's report at 6-week postpartum visit

  7. Perceived Stress Scale (PSS) [ Time Frame: Change from Baseline visit to end of 12 week intervention visit and at 1 year follow-up ]
    Stress

  8. 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

  9. total # of minutes in physical activity (including yoga) [ Time Frame: End of 12 week intervention ]
    Adherence to physical activity aspect of intervention (including yoga)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953990


Locations
Layout table for location information
United States, Virginia
Virginia Commonwealth University School of Nursing
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Patricia A Kinser, PhD Virginia Commonwealth University

Layout table for additonal information
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT02953990     History of Changes
Other Study ID Numbers: HM20006941
1R15HD086835-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: February 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Virginia Commonwealth University:
Pregnancy
Self-Management
Yoga

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms