The Stony Brook University Calm-Mom Study

Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

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.

Prenatal Maternal Stress, Perinatal Mental Health, Pregnancy, Perinatal Anxiety, Perinatal Depression

Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal.

Participants (n = 30) will be randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers.

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).

Gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress.

Measure of prenatal maternal distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.

Standardized depression symptom measure. Total scores range from 8-40; higher values represent greater distress/depression.

Standardized anxiety symptom measure. Total scores range from 6-30; higher values represent greater anxiety.

Widely used mindfulness measure; total scores range from 12-60; higher scores represent greater mindfulness.

Measure of stress-related coping. Total scores range from 0-52; higher scores represent better coping.

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

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.

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.

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.