The Stony Brook University Calm-Mom Study
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Intervention versus treatment as usual.
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention |
Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal. |
|
|
Active Comparator 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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04018625
- Status
- Completed
- Sponsor
- Stony Brook University
Detailed 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.