The Stony Brook University Calm-Mom Study

Stony Brook University

Status: Completed

Conditions: Perinatal Depression; Pregnancy Related; Anxiety; Stress, Psychological

Treatments: Behavioral: Mama Support; Behavioral: SMART Mom

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04018625

K23HD092888 (U.S. NIH Grant/Contract)

972565-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: SMART Mom

Treatment as usual

Active Comparator group

Description:

Participants (n = 30) will be randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers.

Treatment:

Behavioral: Mama Support