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Completed

NCT Number: NCT04018625

The Stony Brook University Calm-Mom Study

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.

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Key information

Conditions

Pregnancy Related Anxiety Anxiety Disorders Behavior Behavioral Symptoms Mental Disorders Perinatal Depression Stress, Psychological

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook University, Department of Psychiatry

Stony Brook, New York, 11794, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMART Mom

Behavioral

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).

Mama Support

Behavioral

Participants will be enrolled in an 8-week time and attention matched, process-based support group.

Primary outcomes

  1. 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.

  2. 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

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Depression

    Time frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment

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

  2. Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety

    Time frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment

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

  3. Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

    Time frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment

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

  4. Measure of Current Status-Form A (MOCS-A)

    Time frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment

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

Other outcomes

  1. Birthweight

    Time frame: Chart review occurring at 6 week postpartum visit.

    Infant weight (in grams) at birth.

  2. Gestational Age

    Time frame: Chart review occurring at 6 week postpartum visit.

    Infant gestational age (in weeks) at birth.

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2019
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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