Healthy Expectations - a Program for Pregnant Women Experiencing Depressive Symptoms
Completed · Not applicable
Conditions studied: Depressive Symptoms, Pregnancy
In brief
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.
Key facts
- Study ID
- NCT02474862
- Run by
- Butler Hospital
- People needed
- 119
- Starts
- 2015-03-24
- Expected to finish
- 2020-09-30
- Last updated by the study team
- 2025-02-05
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- women aged 18 or over
- 12-27 weeks gestation with a healthy singleton pregnancy
- English-speaking
- cleared by prenatal provider for moderate intensity exercise
- experiencing moderate depressive symptom elevations at time of enrollment (QIDS-C; 8-20); (6) physically inactive or low-active at time of enrollment (mean < 90 minutes/week of moderate intensity exercise, over the last 3 months).
You may not qualify if…
- 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
- current/recent acute suicidal symptoms
- current substance use disorder
- psychotic symptoms or cognitive impairment
- current eating disorder
- 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:
- current significant physical or neurological illness, ie., acute or chronic infectious, inflammatory or immune disorders
- regular use of aspirin or non-steroidal anti-inflammatory drugs.
Where it is running
- Butler Hospital — Providence, Rhode Island, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.