Healthy Expectations - A Program for Pregnant Women Experiencing Depressive Symptoms

Description

This study is a randomized control trial (RCT) evaluating a Prenatal Walking Program (PWP) in comparison to a Postpartum Prep Program (PPP) comparison group for pregnant women experiencing depressive symptoms. In addition to assessing changes in depressive symptoms, the investigators will examine other key maternal outcomes (maternal functioning, pain, anxiety, stress, fatigue), as well as infant outcomes including birth record data (gestation, weight, Apgar scores, etc) and careful, in-person assessment of infant neurobiological functioning at 30 days postpartum.

Study Start Date

March 2015

Estimated Completion Date

September 2020

Interventions

  • Behavioral: Prenatal Walking Program
  • Behavioral: Postpartum Prep Program

Specialties

  • Nursing: Mental Health,Women`s Health
  • Obstetrics & Gynecology: Obstetrics
  • Psychiatry: Anxiety
  • Family Medicine: Obstetrics,Psychiatry,Women`s Health

MeSH Terms

  • Depressive Symptoms
  • Pregnancy

Study ID

Butler Hospital -- R01NR014540-01A1

Status

Unknown

Trial ID

NCT02474862

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

152

Sponsor

Butler Hospital

Inclusion Criteria

    1. women aged 18 or over 2. 12-26 weeks gestation with a healthy singleton pregnancy 3. English-speaking 4. cleared by prenatal provider for moderate intensity exercise 5. experiencing moderate depressive symptom elevations at time of enrollment (QIDS-C 9-20) (6) physically inactive or low-active at time of enrollment (mean < 90 minutes/week of moderate intensity exercise, over the last 3 months).

Exclusion Criteria

    1. recently started pharmacologic or psychosocial treatment for depressive symptoms within the past 4 weeks, or recently changed dose or treatment regimen in the past 4 weeks 2. current/recent acute suicidal symptoms 3. current substance use disorder 4. psychotic symptoms or cognitive impairment 5. current eating disorder 6. current or lifetime bipolar disorder, schizophrenia, or schizoaffective disorder.
  • Finally, while the following will not exclude participants from enrollment in the study, women meeting these two criteria will be excluded from participating in the blood draw component examining inflammatory markers: 7. current significant physical or neurological illness, ie., acute or chronic infectious, inflammatory or immune disorders 8. regular use of aspirin or non-steroidal anti-inflammatory drugs.

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Butler Hospital - Providence, Rhode Island 39.6 miles Cynthia Battle PhD 401-455-6371 cynthia_battle@brown.edu

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