The Stony Brook University Calm-Mom Study

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pregnancy Related, Stress, Psychological, Anxiety, Perinatal Depression

Intervention / Treatment
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* Behavioral: SMART Mom
* Behavioral: Mama Support


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention versus treatment as usual.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal. | Behavioral: SMART Mom<br>* 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).<br>|
| Active Comparator: Treatment as usual<br>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<br>* Participants will be enrolled in an 8-week time and attention matched, process-based support group.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal Maternal Stress, Perinatal Mental Health, Pregnancy, Perinatal Anxiety, Perinatal Depression