Healthy Expectations - A Program for Pregnant Women Experiencing Depressive Symptoms

Pregnancy Clinical Trial

— HE  

Official title:

RCT of a Tailored Walking Program to Reduce Stress Among Pregnant Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02474862
• Other study ID #: R01NR014540-01A1
• Status: Completed
• Phase: N/A
• Start date: March 24, 2015
• Est. completion date: September 30, 2020

Study information

• Verified date: December 2020
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Depressive symptoms are prevalent among pregnant women, and they are consistently linked with adverse outcomes for both women and infants, including higher rates of spontaneous abortion, preeclampsia, operative delivery, and postpartum depression. Additional risks to offspring include pre-term delivery, neonatal growth retardation, low birth weight, and delayed developmental milestones. In spite of these risks, the vast majority of affected women do not pursue any type of mental health treatment. Many women are reluctant to use antidepressants - or anything that could potentially harm the baby - prenatally. Because pregnant women have unique concerns regarding treatment acceptability, a critical need exists to develop interventions that are not only efficacious in reducing depressive symptoms, but are also viewed as acceptable by pregnant women.

Increased physical activity has numerous advantages as a strategy for improving mood during pregnancy, and prior research has shown that physical activity interventions can be effective in treating depressive symptoms in the general population. Physical activity interventions are also inexpensive, safe, and associated with a variety of positive health outcomes.

In spite of its potential as an acceptable and efficacious strategy for improving prenatal mood, few studies have evaluated physical activity as an intervention for pregnant women with depressive symptoms. Existing exercise programs that have been tested for reducing depressive symptoms in the general population are not likely to be appropriate or feasible for pregnant women. In light of this important gap, the investigators interdisciplinary team developed a gentle, 10-week, pedometer walking intervention tailored for pregnant women, the Prenatal Walking Program (PWP) and preliminarily evaluated PWP in an open trial, finding the intervention to be safe, feasible, and acceptable.

The current RCT will now evaluate PWP in comparison to a health education control comparison group tailored for perinatal women, called the Postpartum Prep Program (PPP). 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 and in-person assessment of infant neurobiological functioning. Further, the investigators will examine evidence for potential behavioral, psychological, and biological mechanisms of action that mediate a possible treatment effect. Up to 152 pregnant women reporting elevated depressive symptoms during the current pregnancy will be enrolled and randomized into one of two groups, PWP or PPP, and will participate in blinded follow-up evaluations at multiple time-points throughout pregnancy and postpartum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. women aged 18 or over

2. 12-27 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; 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).

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.

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms
• Pregnancy

Intervention

Behavioral:
• Prenatal Walking Program
PWP is a gentle walking intervention tailored for pregnant women.
• Postpartum Prep Program
PPP participants will attend individually education sessions matched in number and duration to the sessions in PWP. PPP involves providing health information particularly relevant to expectant mothers, including both maternal and newborn well being.

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Butler Hospital	Brown University, Women and Infants Hospital of Rhode Island

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression symptom severity	The Quick Inventory of Depression Symptoms (QIDS) is the primary outcome measure and will be used to assess depression symptom severity.	Change from baseline in depression severity at week 10
Secondary	Physical activity level	Objective measurement using accelerometry and self-report	Change from baseline in physical activity level at week 10
Secondary	Anxiety	State Anxiety Scale	Change from baseline in anxiety level at week 10
Secondary	Perceived stress	Perceived Stress Scale -10	Change from baseline in perceived stress at week 10
Secondary	Health status - Inflammatory Biomarker 1	plasma interleukin-6 (IL-6)	Change from baseline in health status at week 10
Secondary	Health status - Inflammatory Biomarker 2	plasma IL-1 beta (IL-1ß)	Change from baseline in health status at week 10
Secondary	Health status - Inflammatory Biomarker 3	plasma tumor necrosis factor - alpha (TNF- a)	(CRP).Change from baseline in health status at week 10
Secondary	Health status - Inflammatory Biomarker 4	serum high sensitivity C-reactive protein (CRP).	Change from baseline in health status at week 10
Secondary	Physical functioning	Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Phys. Function 10a	Change from baseline in physical functioing at week 10
Secondary	Physical Pain	Patient Reported Outcomes Measurement Information System (PROMIS)- Pain Short Form v1.0	Change from baseline in pain at week 10
Secondary	Fatigue	Patient Reported Outcomes Measurement Information System (PROMIS)- Short Form v1.0 - Fatigue 8a Participant Version	Change from baseline in fatigue at week 10
Secondary	Pregnancy discomfort	Maternal Physical Discomfort Scale	Change from baseline in pregnancy at week 10
Secondary	Quality of life and satisfaction	Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form	Change from baseline in quality of life at week 10
Secondary	Attachment to fetus/infant	Maternal Antenatal Attachment Scale	Change from baseline in attachment to the fetus at week 10
Secondary	Infant Outcome	This outcome will be based on a composite of measures relating to labor & delivery outcomes (e.g. gestational age) and infant neurobehavioral functioning (i.e., the Neonatal Intensive Care Unit Network Neurobehavioral Scale; NNNS).	30-days postpartum