Pregnancy RelatedNCT04018625
The Stony Brook University Calm-Mom Study
A study testing SMART Mom and Mama Support in people with Pregnancy Related and Stress, Psychological, run by Stony Brook University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Related, Stress, Psychological, Anxiety
- What is being tested?
- SMART Mom and Mama Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University, Department of Psychiatry
Stony Brook, New York, 11794
About this study
Official title: An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress
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.
Read the 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.
- Being tested
- SMART Mom, Mama Support
- Keywords
- Prenatal Maternal Stress, Perinatal Mental Health, Pregnancy, Perinatal Anxiety, Perinatal Depression
- Medical subject headings
- Stress, Psychological, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMART MomBehavioural
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).
Mama SupportBehavioural
Participants will be enrolled in an 8-week time and attention matched, process-based support group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal. Receives: 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. Receives: Behavioral: Mama Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Stress as Indexed by Perceived Stress Scale (PSS-10) Score
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.
Measured: 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).
Change in Prenatal Maternal Distress as Indexed by the New Prenatal Distress Questionnaire (NuPDQ) Score
The New Prenatal Distress Questionnaire (NuPDQ) is a measure of prenatal maternal psychological distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
Measured: T0 (baseline), T2 mid-treatment (4 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Secondary outcomes (4)
Patient Health Questionnaire. PHQ-9.
The 9-item Patient Health Questionnaire (PhQ-9) is a standardized depression symptom measure. Scores range from 0-27, higher scores indicate greater depression symptoms.
Measured: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Generalized Anxiety Disorder -7 Item (GAD-7).
Generalized Anxiety Disorder -7 item is a standardized anxiety symptom measure. Scores range from 0-21, higher scores indicate greater anxiety symptoms.
Measured: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Widely used mindfulness measure; total scores range from 12-60; higher scores represent greater mindfulness.
Measured: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Measure of Current Status-Form A (MOCS-A)
The Measure of Current Status-Form A (MOCS-A) is a measure of stress-related coping. Total scores range from 0-52; higher scores represent better coping.
Measured: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Apr 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention versus treatment as usual.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Brittain Lynn Mahaffey, Stony Brook University
- Investigators
- Brittain L Mahaffey, PhD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018625
- Sponsor's protocol ID
- 972565-4
- Other IDs
- K23HD092888
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2019
- Last updated
- 20 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators are committed to sharing the research data that is generated in this proposal. Research data will be shared according to NIH guidelines. All research data is collected and stored in accordance with HIPAA compliance, and any shared datasets resulting from human participant research will be free of any identifiers that would allow disclosure of individual subjects.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress
- ClinicalTrials.gov ID
- NCT04018625
- Acronym / sponsor ID
- 972565-4
- Keywords
- Prenatal Maternal Stress, Perinatal Mental Health, Pregnancy, Perinatal Anxiety, Perinatal Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Posted 20 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Intervention versus treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SMART MomParticipants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal. |
| Treatment as usual | Active comparator | Behavioral: Mama SupportParticipants (n = 30) will be randomized to receive treatment as usual, including referrals to community based support groups and individual mental health providers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- <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).
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMART MomSMART 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). | Behavioural | Intervention |
| Mama SupportParticipants will be enrolled in an 8-week time and attention matched, process-based support group. | Behavioural | Treatment as usual |
Primary outcome
Change in Perceived Stress as Indexed by Perceived Stress Scale (PSS-10) Score
Time frame: 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).
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.
Change in Prenatal Maternal Distress as Indexed by the New Prenatal Distress Questionnaire (NuPDQ) Score
Time frame: T0 (baseline), T2 mid-treatment (4 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
The New Prenatal Distress Questionnaire (NuPDQ) is a measure of prenatal maternal psychological distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
4 secondary outcomes
Patient Health Questionnaire. PHQ-9.
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Generalized Anxiety Disorder -7 Item (GAD-7).
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Cognitive and Affective Mindfulness Scale-Revised (CAMS-R)
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Measure of Current Status-Form A (MOCS-A)
Time frame: Baseline (T0), T2 mid-treatment (4 weeks post enrollment), T3 post treatment (8 weeks post enrollment), T4 delayed follow up (20 weeks post enrollment). Not assessed at T1 (Enrollment, <2 weeks post T0).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The investigators are committed to sharing the research data that is generated in this proposal. Research data will be shared according to NIH guidelines. All research data is collected and stored in accordance with HIPAA compliance, and any shared datasets resulting from human participant research will be free of any identifiers that would allow disclosure of individual subjects.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brittain L Mahaffey, PhD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMART Mom and Mama Support in people with Pregnancy Related and Stress, Psychological, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress as Indexed by Perceived Stress Scale (PSS-10) Score (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.