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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
63
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).
Participants will be enrolled in an 8-week time and attention matched, process-based support group.
Stony Brook University, Department of Psychiatry
Stony Brook, New York, United States
Change in Perceived Stress as Indexed by Perceived Stress Scale (PSS-10) Score
The Perceived Stress Scale (PSS-10) is the gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress or a worse outcome.
Time frame: T1 (treatment session 1/enrollment date, occurred within <2 weeks of baseline T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment).
Change in Prenatal Maternal Distress as Indexed by the New Prenatal Distress Questionnaire (NuPDQ) Score
The New Prenatal Distress Questionnaire (NuPDQ) is a measure of prenatal maternal psychological distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
Time frame: T0 (baseline), T2 mid-treatment (4 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Patient Health Questionnaire. PHQ-9.
The 9-item Patient Health Questionnaire (PhQ-9) is a standardized depression symptom measure. Scores range from 0-27, higher scores indicate greater depression symptoms.
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Generalized Anxiety Disorder -7 Item (GAD-7).
Generalized Anxiety Disorder -7 item is a standardized anxiety symptom measure. Scores range from 0-21, higher scores indicate greater anxiety symptoms.
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Widely used mindfulness measure; total scores range from 12-60; higher scores represent greater mindfulness.
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Measure of Current Status-Form A (MOCS-A)
The Measure of Current Status-Form A (MOCS-A) is a measure of stress-related coping. Total scores range from 0-52; higher scores represent better coping.
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
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