Trial Outcomes & Findings for The Stony Brook University Calm-Mom Study (NCT NCT04018625)

Results Overview

The Perceived Stress Scale (PSS-10) is the gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress or a worse outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

63 participants

Primary outcome timeframe

T1 (treatment session 1/enrollment date, occurred within <2 weeks of baseline T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment).

Results posted on

2026-08-20

Participant Flow

Participants were recruited online through social media forums including Facebook and Instagram as well as from physician referral (from Stony Brook Medicine OBGYN) beginning on January 1st 2021 and enrollment occurred between from April 1st 2021 though September 2023.

Eligibility Criteria: (1) \< 25 weeks pregnant with medically confirmed viability, (2) speak, read and write in English, and (3) endorse elevated levels of PNMS (at least 1 SD higher than the population on NuPDQ). Exclusion Criteria: (1) current enrollment in psychotherapy, (2) current un-managed serious mental illness; (3) history of previous suicide attempt, (4) planning to move from Long Island in the next six months.

Participant milestones

Participant milestones
Measure	Intervention Participants (n = 33) were randomized to receive the SMART Pregnancy stress management program via an online portal. 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).	Treatment as Usual Participants (n = 30) were randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers. Mama Support: Participants will be enrolled in an 8-week time and attention matched, process-based support group.
Overall Study STARTED	33	30
Overall Study COMPLETED	19	21
Overall Study NOT COMPLETED	14	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Stony Brook University Calm-Mom Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=33 Participants Participants (n = 33) were randomized to receive the SMART Pregnancy stress management program via an online portal. 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).	Treatment as Usual n=30 Participants Participants (n = 30) were randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers. Mama Support: Participants will be enrolled in an 8-week time and attention matched, process-based support group.	Total n=63 Participants Total of all reporting groups
Age, Continuous	31.55 years STANDARD_DEVIATION 3.74 • n=5 Participants	32.88 years STANDARD_DEVIATION 4.88 • n=109 Participants	32.16 years STANDARD_DEVIATION 4.32 • n=133 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	30 Participants n=109 Participants	63 Participants n=133 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=109 Participants	1 Participants n=133 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=109 Participants	6 Participants n=133 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	2 Participants n=109 Participants	6 Participants n=133 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	20 Participants n=109 Participants	43 Participants n=133 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=109 Participants	0 Participants n=133 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	5 Participants n=109 Participants	7 Participants n=133 Participants
Region of Enrollment United States	33 Participants n=5 Participants	30 Participants n=109 Participants	63 Participants n=133 Participants
Perceived Stress Scale (PSS)	21.59 units on a scale STANDARD_DEVIATION 7.52 • n=5 Participants	18.31 units on a scale STANDARD_DEVIATION 6.42 • n=109 Participants	20.07 units on a scale STANDARD_DEVIATION 7.18 • n=133 Participants
New Prenatal Distress Questionnaire (NuPDQ)	18.97 units on a scale STANDARD_DEVIATION 5.37 • n=5 Participants	15.96 units on a scale STANDARD_DEVIATION 6.08 • n=109 Participants	17.57 units on a scale STANDARD_DEVIATION 5.86 • n=133 Participants

PRIMARY outcome

Timeframe: T1 (treatment session 1/enrollment date, occurred within <2 weeks of baseline T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment).