Clinical trial NCT04018625: The Stony Brook University Calm-Mom Study
Official title: An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Stress, Psychological
Anxiety
Perinatal Depression
Keywords: Prenatal Maternal Stress
Perinatal Mental Health
Pregnancy
Perinatal Anxiety
Perinatal Depression
Lead sponsor: Stony Brook University
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-12
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention versus treatment as usual.
Primary purpose: TREATMENT

Brief summary: The present trial will evaluate the feasibility, acceptability and preliminary efficacy of 2 different internet-delivered programs for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Mom program), an 8-session Cognitive Behavior Therapy (CBT) based mind body program and the Mama Support Program, an 8-session social support group program. Sixty pregnant women (\<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Mom Program or the Mama Support Program. Outcomes, including maternal perceived stress, depression, and anxiety will be assessed at post-treatment, three, and six months post program completion. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.

Detailed description: Aim 1: The investigators will conduct a randomized clinical trial (RCT; n=60) to assess the feasibility, acceptability and preliminary efficacy of the Stress Management and Resillency Training program (SMART Pregnancy) delivered online versus a time and attention matched prenatal support group (Mama Support). It is expected that SMART-pregnancy participants will demonstrate high levels of treatment engagement and adherence. It is predicted that participants in the SMART-Pregnancy condition will demonstrate improvements in emotional distress and stress regulation (as indexed by hair cortisol concentrations) at post-treatment and 3 month follow-up. Aim 2: The investigators will conduct a postnatal chart review to explore secondary treatment benefits including pre-and postnatal maternal health and birth outcomes.

Eligibility criteria: Inclusion Criteria:

* \<21 weeks pregnant with medically confirmed viability
* Speak, read and write in English fluently,
* Endorse elevated levels of prenatal maternal stress (PNMS; i.e., New Prenatal Distress Questionnaire Score \> 19).

Exclusion Criteria:

* Current enrollment in individual or group psychotherapy
* Current un-managed serious mental illness including bipolar disorder and psychosis
* History of previous suicide attempt
* Inappropriate for participation in group therapy format as determined by study director

Primary outcomes:
measure: Change in perceived stress as indexed by Perceived Stress Scale (PSS) score
timeFrame: baseline, 8 weeks post enrollment, 20 weeks post enrollment
measure: Change in prenatal maternal distress as indexed by Prenatal Distress Questionnaire (NuPDQ) score
timeFrame: baseline, 8 weeks post enrollment
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Depression
timeFrame: baseline, 8 weeks post enrollment, 20 weeks post enrollment
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety
timeFrame: baseline, 8 weeks post enrollment, 20 weeks post enrollment
measure: Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
timeFrame: baseline, 8 weeks post enrollment, 20 weeks post enrollment
measure: Measure of Current Status-Form A (MOCS-A)
timeFrame: baseline, 8 weeks post enrollment, 20 weeks post enrollment
Other outcomes:
measure: Birthweight
timeFrame: Chart review occurring at 6 week postpartum visit.
measure: Gestational Age
timeFrame: Chart review occurring at 6 week postpartum visit.
Locations:
city: Stony Brook
country: United States
facility: Stony Brook University, Department of Psychiatry
state: New York
Study officials:
affiliation: Stony Brook University
name: Brittain L Mahaffey, PhD
role: PRINCIPAL_INVESTIGATOR
References: