The Stony Brook University Calm-Mom Study

An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress

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.

Study Overview

• Status: Completed
• Conditions: Stress, Psychological; Anxiety; Pregnancy Related; Perinatal Depression
• Intervention / Treatment: Behavioral: SMART Mom; Behavioral: Mama Support

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brittain L Mahaffey, PhD; Phone Number: 631-632-6332; Email: brittain.mahaffey@stonybrookmedicine.edu
• Study Contact Backup: Name: Adam Gonzalez, PhD; Phone Number: 6316328675; Email: adam.gonzalez@stonybrookmedicine.edu

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook University, Department of Psychiatry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal.	Behavioral: SMART Mom; SMART Pregnancy is an 8-session online stress management program offered in a group format. SMART Pregnancy is an adaptation of the Stress Management and Resiliency Training Program (Park et al., 2012).
Active Comparator: Treatment as usual; Participants (n = 30) will be randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers.	Behavioral: Mama Support; Participants will be enrolled in an 8-week time and attention matched, process-based support group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived stress as indexed by Perceived Stress Scale (PSS) score	Gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress.	baseline, 8 weeks post enrollment, 20 weeks post enrollment
Change in prenatal maternal distress as indexed by Prenatal Distress Questionnaire (NuPDQ) score	Measure of prenatal maternal distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.	baseline, 8 weeks post enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Depression	Standardized depression symptom measure. Total scores range from 8-40; higher values represent greater distress/depression.	baseline, 8 weeks post enrollment, 20 weeks post enrollment
Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety	Standardized anxiety symptom measure. Total scores range from 6-30; higher values represent greater anxiety.	baseline, 8 weeks post enrollment, 20 weeks post enrollment
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)	Widely used mindfulness measure; total scores range from 12-60; higher scores represent greater mindfulness.	baseline, 8 weeks post enrollment, 20 weeks post enrollment
Measure of Current Status-Form A (MOCS-A)	Measure of stress-related coping. Total scores range from 0-52; higher scores represent better coping.	baseline, 8 weeks post enrollment, 20 weeks post enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Birthweight	Infant weight (in grams) at birth.	Chart review occurring at 6 week postpartum visit.
Gestational Age	Infant gestational age (in weeks) at birth.	Chart review occurring at 6 week postpartum visit.

Collaborators and Investigators

• Sponsor: Stony Brook University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Massachusetts General Hospital
• Investigators: Principal Investigator: Brittain L Mahaffey, PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: July 9, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 28, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Perinatal Depression; Prenatal Maternal Stress; Perinatal Mental Health; Perinatal Anxiety
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Stress, Psychological
• Other Study ID Numbers: 972565-4; K23HD092888 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators are committed to sharing the research data that is generated in this proposal. Research data will be shared according to NIH guidelines. All research data is collected and stored in accordance with HIPAA compliance, and any shared datasets resulting from human participant research will be free of any identifiers that would allow disclosure of individual subjects.
• IPD Sharing Time Frame: Timelines for distribution of data will vary, however the study team will make every effort to make data available in a timely fashion. It is expected that data from this proposal will presented at scientific meetings, and publications will be made available through PubMed Central no later than 12 months after publication.
• IPD Sharing Access Criteria: The data will be available to users under a data sharing agreement that includes a commitment to: 1) using the data for research purposes only, 2) properly securing the data in accordance with HIPAA compliance requirements, and 3) destroying the data after analyses are completed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No