Anxiety, Perinatal Depression, Pregnancy Related, Stress, Psychological
Conditions
Keywords
Prenatal Maternal Stress, Perinatal Mental Health, Pregnancy, Perinatal Anxiety, Perinatal Depression
Brief 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 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.
Interventions
BEHAVIORALSMART 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).
BEHAVIORALMama Support
Participants will be enrolled in an 8-week time and attention matched, process-based support group.
Sponsors
Stony Brook University
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Intervention versus treatment as usual.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress as Indexed by Perceived Stress Scale (PSS-10) Score | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Generalized Anxiety Disorder -7 Item (GAD-7). | 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 is a standardized anxiety symptom measure. Scores range from 0-21, higher scores indicate greater anxiety symptoms. |
| Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) | 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). | Widely used mindfulness measure; total scores range from 12-60; higher scores represent greater mindfulness. |
| Measure of Current Status-Form A (MOCS-A) | 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). | 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. |
| Patient Health Questionnaire. PHQ-9. | 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). | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrittain L Mahaffey, PhD
Stony Brook University
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 32.16 years STANDARD_DEVIATION 4.32 |
| New Prenatal Distress Questionnaire (NuPDQ) | 15.96 units on a scale STANDARD_DEVIATION 6.08 |
| Perceived Stress Scale (PSS) | 18.31 units on a scale STANDARD_DEVIATION 6.42 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 63 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
None listed