Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
Collaborators:
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Brittain Lynn Mahaffey, Stony Brook University

Brief Summary:
The present trial will evaluate the feasibility, acceptability and preliminary efficacy of inter-net-delivered mind-body program for prenatal maternal stress. The Stress Managment and Resiliency Training Program (SMART-Pregnancy program) is a 8-session Cognitive Behavior Therapy (CBT) based program which teaches strategies for eliciting the relaxation response, improving cognitive flexibility and developing adaptive coping strategies. Sixty pregnant women (<20 weeks Estimated Gestational Age) will be screened and either enrolled in the online SMART Pregnancy program or referred for treatment as usual. Outcomes, including maternal perceived stress, depression and anxiety will be assessed at 8-weeks and 20-weeks post randomization. Potential impact on infant health outcomes will be assessed via post-delivery electronic medical record review.

Condition or disease Intervention/treatment Phase
Pregnancy Related Stress, Psychological Anxiety Perinatal Depression Behavioral: SMART Pregnancy Behavioral: Treatment as usual Not Applicable

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 treatment as usual (TAU). 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Intervention versus treatment as usual.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Intervention
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. Birthweight [ Time Frame: Chart review occurring at 6 week postpartum visit. ]
    Infant weight (in grams) at birth.

  2. Gestational Age [ Time Frame: Chart review occurring at 6 week postpartum visit. ]
    Infant gestational age (in weeks) at birth.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20 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
  • Planning to move from Long Island in the next six months

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Brittain L Mahaffey, PhD 631-632-6332 brittain.mahaffey@stonybrookmedicine.edu
Contact: Adam Gonzalez, PhD 6316328675 adam.gonzalez@stonybrookmedicine.edu

Locations
Layout table for location information
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    brittain.mahaffey@stonybrookmedicine.edu   
Contact       brittainmahaffey@gmail.com   
Principal Investigator: Brittain L Mahaffey, PhD         
Sponsors and Collaborators
Stony Brook University
Massachusetts General Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Brittain L Mahaffey, PhD Stony Brook University

Layout table for additonal information
Responsible Party: Brittain Lynn Mahaffey, Assistant Professor, Stony Brook University
ClinicalTrials.gov Identifier: NCT04018625     History of Changes
Other Study ID Numbers: 972565-4
K23HD092888 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Timelines for distribution of data will vary, however the study team will make every effort to make data available in a timely fashion. It is expected that data from this proposal will presented at scientific meetings, and publications will be made available through PubMed Central no later than 12 months after publication.
Access Criteria: The data will be available to users under a data sharing agreement that includes a commitment to: 1) using the data for research purposes only, 2) properly securing the data in accordance with HIPAA compliance requirements, and 3) destroying the data after analyses are completed.
URL: http://publicaccess.nih.gov/policy.htm

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brittain Lynn Mahaffey, Stony Brook University:
Prenatal Maternal Stress
Perinatal Mental Health
Pregnancy
Perinatal Anxiety
Perinatal Depression

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Stress, Psychological
Asphyxia Neonatorum
Behavioral Symptoms
Infant, Newborn, Diseases