An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pregnancy Related
- Sponsor
- Stony Brook University
- Enrollment
- 79
- Locations
- 1
- Primary Endpoint
- Change in perceived stress as indexed by Perceived Stress Scale (PSS) score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Brittain Lynn Mahaffey
Assistant Professor
Stony Brook University
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
Outcomes
Primary Outcomes
Change in perceived stress as indexed by Perceived Stress Scale (PSS) score
Time Frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment
Gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress.
Change in prenatal maternal distress as indexed by Prenatal Distress Questionnaire (NuPDQ) score
Time Frame: baseline, 8 weeks post enrollment
Measure of prenatal maternal distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
Secondary Outcomes
- Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Depression(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety(baseline, 8 weeks post enrollment, 20 weeks post enrollment)
- Measure of Current Status-Form A (MOCS-A)(baseline, 8 weeks post enrollment, 20 weeks post enrollment)