The Stony Brook University Calm-Mom Study

NCT04018625 | Completed

• 2 other identifiers: 972565-4K23HD092888
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Stress, Psychological; Anxiety; Perinatal Depression

Keywords

Prenatal Maternal Stress; Perinatal Mental Health; Pregnancy; Perinatal Anxiety; Perinatal Depression

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

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

  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

• Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)

  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

Other Outcomes (2)

• Birthweight

  Chart review occurring at 6 week postpartum visit.

• Gestational Age

  Chart review occurring at 6 week postpartum visit.

Study Arms (2)

Intervention

EXPERIMENTAL

Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal.

Behavioral: SMART Mom

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

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).

Intervention

Mama Support BEHAVIORAL

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

Treatment as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Stony Brook University: lead
• Massachusetts General Hospital: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stony Brook University, Department of Psychiatry

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Brittain L Mahaffey, PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Intervention versus treatment as usual.

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: April 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Timelines for distribution of data will vary, however the study team will make every effort to make data available in a timely fashion. It is expected that data from this proposal will presented at scientific meetings, and publications will be made available through PubMed Central no later than 12 months after publication.
• Access Criteria: The data will be available to users under a data sharing agreement that includes a commitment to: 1) using the data for research purposes only, 2) properly securing the data in accordance with HIPAA compliance requirements, and 3) destroying the data after analyses are completed.

Locations

US (1)