Postpartum Wellness

Postpartum Depression Clinical Trial

— POW  

Official title:

Preventing Postpartum Depression: Exercise as Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414696
• Other study ID #: 1548855
• Status: Completed
• Phase: N/A
• Start date: November 19, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: November 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test whether a web-based (eHealth) exercise intervention for new moms at increased risk for postpartum depression increases physical activity and decreases postpartum depression symptoms.

Description:

Postpartum depression is a debilitating and costly condition that is associated with significant health consequences for mothers and children. Counseling for prevention of postpartum depression is currently recommended in women at high risk of postpartum depression; however, there is a shortage of mental health care providers. There is a need for effective interventions to prevent postpartum depression that can be easily integrated into health care systems, yet do not involve intense health care system resources. eHealth interventions are promising in this regard.

Strong evidence suggests physical activity can reduce depression risk. This study will assess the effectiveness of an eHealth exercise intervention tailored to postpartum mothers for increasing physical activity levels and improving depressive symptoms in women at increased risk of postpartum depression. This intervention addresses several identified barriers to physical activity in postpartum women. The study will randomize 200 women to receive an eHealth exercise intervention for postpartum women or usual postpartum care. Device-based physical activity and depressive symptoms will be measured at 3 and 6 months after randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: May 1, 2023
• Est. primary completion date: December 13, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• KPNC member between 2 and 6 months postpartum

• Current PHQ-8 score between 10-20 and no current depression diagnosis

• Delivered baby in KPNC

• English-speaking

• Own a smartphone, computer, or TV with internet access

• Free of a heart condition and a physician recommending medically supervised physical activity

• Body Mass Index (BMI) between 18.5 and 40 (kg/m2)

• A baby weighing between 11-22 lbs

Exclusion Criteria:

• Engaged in regular, moderate or vigorous physical activity >90 minutes or more per week

• Pregnant or planning to become pregnant in the ensuing three months

• A baby with chronic illness/disorder(s) that prevent participant from holding or lifting him/her

• Chest pain during physical activity, or has had chest pain within the prior month

• Taking medication for hypertension or a heart condition

• Tendency to fall due to syncope or dizziness

• Orthopedic problems that might be aggravated by physical activity

• Has exercise-induced asthma

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• Exercise intervention
eHealth exercise intervention for postpartum women at increased risk of depression

Locations

Country	Name	City	State
United States	Division of Research	Oakland	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sleep	Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI).; The Pittsburgh Sleep Quality Index (PSQI) asks about sleep quality during the past month, including questions on sleep duration, sleep disturbance, and use of sleep-inducing medications. A global score, ranging from 0 to 21, is calculated using seven components of sleep. Higher scores indicate poorer sleep quality.	0-3 months and 3-6 months
Other	Mother-infant bonding	The Mother Infant Bonding Scale by Taylor et al will be used to assess mother-infant bonding.; Mother Infant Bonding Scale scores range from 0-24. Higher scores indicate worse mother-infant bonding.	0-3 months and 3-6 months
Other	Anxiety	The General Anxiety Disorder Scale (GAD-7) will be used to assess anxiety.; GAD-7 scores range from 0-21. A score of 1-4 suggests minimal anxiety, 5-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.	0-3 months and 3-6 months
Other	Stress	Perceived stress will be measured using the Perceived Stress Scale (PSS-10).; PSS-10 scores range from 0-40 with higher scores indicating higher perceived stress. A score of 0-13 suggests low stress, 14-26 moderate stress, and 27-40 high perceived stress.	0-3 months and 3-6 months
Other	Infant development	Ages and Stages questionnaire for 12-month-old infants.; The ASQ-3 screens for delays in infant and child development in five domains: communication, gross motor, fine motor, problem-solving, and personal adaptive skills. Scores for each of the five domains range from 0-60 with higher scores indicating typical development.	At 12 months old
Primary	Depression symptoms	Continuous measure of depressive symptoms as assessed using the Patient Health Questionnaire (PHQ-8).; PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.	0-3 months
Primary	Physical Activity	Device-based (Actigraph-measured) minutes of moderate/vigorous physical activity	0-3 months
Secondary	Physical Activity	Self-report measured minutes of moderate/vigorous physical activity	0-3 months and 3-6 months
Secondary	Physical Activity	Device-based (Actigraph-measured) minutes of moderate/vigorous physical	3-6 months
Secondary	Depressive symptoms	Continuous measure of depressive symptoms as assessed in the Patient Health Questionnaire (PHQ-8).; PHQ-8 scores range from 0-24. A score of 1-4 suggests minimal depression, 5-9 mild depression, 10-14 moderate depression, 15-19 moderately severe depression and 20-24 severe depression.	3-6 months