An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04018625|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Related Stress, Psychological Anxiety Perinatal Depression||Behavioral: SMART Pregnancy Behavioral: Treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Intervention versus treatment as usual.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||An Internet-Delivered Mind-Body Program for Reducing Prenatal Maternal Stress|
|Estimated Study Start Date :||February 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||September 2023|
Participants (n = 30) will be randomized to receive the SMART Pregnancy stress management program via an online portal.
Behavioral: SMART Pregnancy
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).
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.
Behavioral: Treatment as usual
Participant provided with list referrals to community mental health resources and support groups. No active intervention provided by study team.
- Change in perceived stress as indexed by Perceived Stress Scale (PSS) score [ Time Frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment ]Gold standard measure of subjective stress experiences. Total scores range from 0 to 40; higher scores indicate greater stress.
- Change in prenatal maternal distress as indexed by Prenatal Distress Questionnaire (NuPDQ) score [ Time Frame: baseline, 8 weeks post enrollment ]Measure of prenatal maternal distress. Total scores range form 0-35; higher scores indicate greater pregnancy-related distress.
- Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Depression [ Time Frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment ]Standardized depression symptom measure. Total scores range from 8-40; higher values represent greater distress/depression.
- Patient-Reported Outcomes Measurement Information System (PROMIS) V.1 Emotional Distress-Anxiety [ Time Frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment ]Standardized anxiety symptom measure. Total scores range from 6-30; higher values represent greater anxiety.
- Cognitive and Affective Mindfulness Scale-Revised (CAMS-R) [ Time Frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment ]Widely used mindfulness measure; total scores range from 12-60; higher scores represent greater mindfulness.
- Measure of Current Status-Form A (MOCS-A) [ Time Frame: baseline, 8 weeks post enrollment, 20 weeks post enrollment ]Measure of stress-related coping. Total scores range from 0-52; higher scores represent better coping.
- Birthweight [ Time Frame: Chart review occurring at 6 week postpartum visit. ]Infant weight (in grams) at birth.
- Gestational Age [ Time Frame: Chart review occurring at 6 week postpartum visit. ]Infant gestational age (in weeks) at birth.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018625
|Contact: Brittain L Mahaffey, PhDemail@example.com|
|Contact: Adam Gonzalez, PhDfirstname.lastname@example.org|
|United States, New York|
|Stony Brook University, Department of Psychiatry||Not yet recruiting|
|Stony Brook, New York, United States, 11794|
|Contact: Brittain Mahaffey, PhD 919-536-9090 email@example.com|
|Principal Investigator: Brittain L Mahaffey, PhD|
|Principal Investigator:||Brittain L Mahaffey, PhD||Stony Brook University|