Perinatal Depression, Post Partum Depression
Conditions
Brief summary
Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.
Interventions
BEHAVIORALStress reduction program 'A'
Participants will use stress reduction program 'A' app 10-20 min per day for 6 weeks.
BEHAVIORALStress reduction program 'B'
Participants will use stress reduction program 'B' app 10-20 min per day for 6 weeks.
Sponsors
Kaiser Permanente
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Current Kaiser Permanente Permanente Northern California (KPNC) member * Pregnant woman receiving prenatal care at KPNC * Gestational age \<30 weeks * Singleton pregnancy * Self-identify as Black and/or Latina * Moderate to moderately severe depressive symptoms (PHQ-9 score between 10 and 19) and no indication of suicidality * Owns a device with internet access * English- or Spanish-speaking
Exclusion criteria
* Regular stress reduction practice with a mindfulness component (e.g., meditation or yoga more than twice a week) * Deaf * Blind * Acting as gestational carrier/surrogate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | Baseline | Depression scale; total score range of 0-27; higher scores indicate higher depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Perceived Stress Scale | Baseline | 10-item stress scale; total score range of 0-40; higher scores indicate more perceived stress |
| Generalized Anxiety Disorder 7-item scale | Baseline | Anxiety scale; total score for the seven items ranges from 0 to 21; higher scores indicate greater anxiety. |
| Promis Sleep Disturbance - Short Form 6a | Baseline | Scale is composed of 6 items developed to assess the domain of sleep disturbances in the past 7 days. Scores range 6-30 with higher scores indicating greater sleep disturbance. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Brief Resilient Coping Scale | Baseline | 4-item questionnaire that measures resilience and coping with stress using a 5-point Likert scale; Individual items are totaled and range from 4 to 20 with a higher score indicating high resiliency and coping skills. Scores can be categorized as low resilient copers (4-13), medium resilient copers (14-16), and high resilient copers (17-20). |
| UCLA Loneliness Scale | Baseline | 20-item questionnaire assessing the respondent's subjective feelings of loneliness on a 4-point Likert scale; total scores range from 20 to 80 with higher scores correlating with higher degrees of loneliness. A score of 20-34 represents low levels of loneliness, 35-49 represent moderate levels of loneliness, 50-64 represent moderately high levels of loneliness, and 65 and higher represent high levels of loneliness. |
| Mother-to-Infant Bonding Scale (MIBS) | 7 weeks postpartum | 8-item questionnaire designed to assess feelings of the birthing parent toward their baby. The MIBS has demonstrated acceptability and has good internal reliability. Scores range from 0 to 24, with lower scores indicating better parent-infant bonding. |
| Ages and Stages Questionnaire | 7 weeks postpartum | Screens for delays in child development in 5 domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Scores are calculated based on the ASQ-3 scoring guide with scores above the cut-off point indicating typical development categorized as on schedule and scores in the zones indicating the need for monitoring or the need for further assessment categorized as not on schedule. |
Countries
United States
Outcome results
None listed