The Stony Brook University Calm-Mom Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2023-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Pregnancy Related Stress, Psychological Anxiety Perinatal Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Intervention versus treatment as usual.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

SMART Mom

Intervention Type 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).

Treatment as usual

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

Group Type ACTIVE_COMPARATOR

Mama Support

Intervention Type BEHAVIORAL

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

Interventions

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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).

Intervention Type BEHAVIORAL

Mama Support

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No