The Stony Brook University Calm-Mom Study

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018625
• Other study ID #: 972565-4
• Secondary ID: K23HD092888
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2023
• Source: Stony Brook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• SMART Mom
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
Participants will be enrolled in an 8-week time and attention matched, process-based support group.

Locations

Country	Name	City	State
United States	Stony Brook University, Department of Psychiatry	Stony Brook	New York

Sponsors (3)

Lead Sponsor	Collaborator
Stony Brook University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Birthweight	Infant weight (in grams) at birth.	Chart review occurring at 6 week postpartum visit.
Other	Gestational Age	Infant gestational age (in weeks) at birth.	Chart review occurring at 6 week postpartum visit.
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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