Emotional DisturbancesA-RCTNCT03416010

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

A study testing COPE-P in people with Emotional Disturbances and Depression, run by Ohio State University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Emotional Disturbances, Depression, Pregnancy Late
What is being tested?: COPE-P
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 299 participants
Where: 3 sitesUnited States
Study dates: 5 Mar 2018to 20 Apr 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 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

Pregnant women between the ages of 18-40 years old
Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
Self-identified as either Black or Hispanic
Able to read and speak English.
The child participants born to the participants will have their record accessed for data collection.

Who cannot join

Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy.
Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

OSU Total Health and Wellness
Columbus, Ohio, 43210
OSUWMC OB/GYN Clinic
Columbus, Ohio, 43210
Jacobi Medical Center
The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT

The overall purpose of this application is to evaluate the efficacy of an intervention designed to decrease health disparities in pregnant, emotionally distressed, minority women. This randomized controlled trial will test a six session (spaced over 18 weeks) cognitive behavioral skills building (CBSB) prenatal care intervention (specifically designed and based on prior research for pregnant minority women experiencing emotional distress) at three sites (Jacobi Medical Center, New York City and The Ohio State University Total Health and Wellness Clinic, and The Ohio State University Wexner Medical Center OB/GYN Columbus, Ohio.

Read the detailed description

A randomized controlled trial will test a cognitive behavioral skills building intervention (COPE-P) in Black and Hispanic women experiencing emotional distress in two sites (New York and Ohio) to determine if the intervention leads to better health behaviors, better psychosocial health (anxiety, stress, and depressive symptoms), and improved birth and post-natal outcomes in women experiencing emotional distress. Developing scalable prenatal interventions designed to improve birth outcomes as well as maternal physical and psychosocial health is essential to decrease health disparities in pregnant minority women.

Conditions: Emotional Disturbances, Depression, Pregnancy Late, Post-Partum Depression, Anxiety, Nutritional Deficiency
Being tested: COPE-P
Keywords: emotional distress pregnancy disparities minority depression
Medical subject headings: Affective Symptoms, Depression, Depression, Postpartum, Anxiety Disorders, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

COPE-PBehavioural
Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave).
Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones.
Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses.
Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication.
Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.

Study groups in NCT03416010
Study group	Role	What they receive
Control	No intervention	In addition to standard prenatal care the PregnancyPlus attention control group for 6 weeks will receive 1.5 hours of ACOG-designed patient education pamphlets. Material will include prenatal and post-partum education.. Dr. Gennaro will conduct the training of the attention control group midwives. The same protocol for assessing fidelity for COPE-P also will be used for assessing fidelity to the attention control intervention
Intervention	Active comparator	In addition to standard prenatal care the COPE-P intervention group will also receive 1.5 hours each week for 6 weeks the cognitive-behavior skills building program driven by CBT as the theoretical framework by health care providers trained in COPE-P by Dr. Melnyk. The content of the COPE program is driven by the literature review, the theoretical framework, previous studies of COPE interventions with mothers of preterm infants and prior work with pregnant minority women by our team. Receives: Behavioral: COPE-P

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3
Healthy Lifestyle Beliefs Scale survey will be administered at each of the in-person meetings. This scale taps beliefs about various facets of maintaining a healthy lifestyle. This 16-item is scored on a five point Likert-type scale that ranging from 1 strongly disagree to 5 strongly agree. The minimum score is 16 and the maximum score is 80. The higher the score the higher the beliefs of maintaining a healthy lifestyle.
Measured: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3
The Generalized Anxiety Scale (GAD-7) is a 7-item survey which measures anxiety will be administered at each of the in-person meetings. The GAD-7 is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3). Scores range from 0 to 21, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score greater than or equal to 10 indicates moderate and higher anxiety and will be used in this study,
Measured: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3
The Healthy Lifestyle Behaviors Scale survey will be administered at each of the in-person meetings. Participants respond to each of the 15 items (e.g., I exercised regularly; I talked about my worries) on a 5-point Likert-type scale that ranges from 1 strongly disagree to 5 strongly agree. The minimum score is 15 and the maximum score is 75. The higher the score the higher the healthy lifestyle behaviors are practiced.
Measured: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3
The Edinburgh Postnatal Depression Scale (EPDS) is a scale measuring depressive symptoms will be administered at each of the in-person meetings. The Edinburgh Postnatal Depression Scale is a 10 item self-report perinatal depression questionnaire. The scale asks participants to describe how they have felt in the previous week. Unlike other depression screening tools, the EPDS excludes questions regarding somatic symptoms of pregnancy and has been found to be equivalent to a structured interview in determining prevalence of depression. Scores range from 0-30 with higher scores signifying higher severity of depressive symptoms. A cut-off score of 10 on the EPDS will be used in this study to indicate moderate depressive symptoms.
Measured: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Change Self-reported Stress at Timepoint 0 to Timepoint 3
The Perceived Stress Scale (PSS) is a scale measuring stress will be administered at each of the in-person meetings. This scale is a standardized measure of global stress designed to elicit the degree to which respondents find their lives unpredictable, uncontrollable, and overloading (three central components of stress). The minimum score is 0 and the maximum score is 40. A higher score is correlated with a higher amount of stress. A score of 20 or greater is the high stress cut-off and will be used in this study.
Measured: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)

Secondary outcomes (14)

Birth Weight
record of birth weight as recorded in patient's medical file
Measured: T2= 6-8 week postpartum visit
Breastfeeding Initiation
Initiation of breastfeeding according to self-report at Timepoint 2: "Did you ever breastfeed or try to breastfeed your baby?". Responses below indicated number of participants that responded "yes" to this question.
Measured: T2= 6-8 week postpartum visit
Breastfeeding Duration
Self-reported maintenance of breastfeeding at approximately 6 months postpartum, inclusive of participants that responded both breastfeeding only and combined breast and bottle feeding (formula vs breastmilk not specified in question to participants).
Measured: T3 = at 6 month well baby visit
Mode of Delivery
(C/S, Vaginal, Forceps/Vacuum)
Measured: T2= 6-8 week postpartum visit
Nutritional Intake
Nutrition behaviors as reflected in response to likert scale-type question "I eat fresh fruits and vegetable snacks". Reponses included Strongly Disagree (1), Disagree (2), Neither Agree Nor Disagree (3), Agree (4), Strongly Agree (5).
Measured: Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Level of Exercise
Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
Measured: T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Gestational Age at Birth
Gestational age at birth will be collected as reported on patient's medical chart
Measured: T2= 6-8 week postpartum visit
Weight
weight in pounds
Measured: Timepoint 0 (<19 weeks gestation)
Participant Body Mass Index (BMI)
derived calculation from weight and height values reported at each of the in person meetings
Measured: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Participant Height
height in feet and inches will be recorded at each of the in person meetings
Measured: Timepoint 0 (Baseline at screening)
Group Prenatal Care Acceptability
Survey addressing participant responses to prenatal care in a group setting with 12 Likert scale-type responses: strongly disagree, disagree, neutral, agree, and strongly agree. Participants were also provided a free text box.
Reported are responses to the question "I would recommend group prenatal care to a friend".
Measured: T1=31 gestational weeks
Program Evaluation: Delivery Method
Separate forms for intervention and attention control that collected data regarding participant experience in study program as well as delivery method, virtually or in-person. Delivery method was ranked by participants 1-4 for preference: 1:1 in person, 1:1 by telehealth, in small group in person, in small group by telehealth.
Measured: Timepoint 3, approximately 6 months postpartum
COPE-P Acceptability
Survey administered with likert-style scale exploring participant satisfaction with different aspects of COPE-P. Participant score range 1 (Strongly Disagree) - 5 (Strongly Agree). Minimum score of 21, maximum of 105. High scores indicate higher satisfaction with the COPE-P program and its elements.
Measured: Timepoint 2 (6 to 8 weeks postpartum)
Program Evaluation
Separate forms for intervention and attention control that collected data regarding participant experience in study program as well as delivery method, virtually or in-person. Delivery method was ranked by participants 1-4 for preference: 1:1 in person, 1:1 by telehealth, in small group in person, in small group by telehealth.
Measured: Timepoint 3, approximately 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 201820 Apr 2023

First posted30 Jan 2018
Study start5 Mar 2018
Primary completion20 Apr 2023
Study completion20 Apr 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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Emotional DisturbancesStudies of the same condition, open and under way.
More trials run by Ohio State UniversityThe sponsor's other registered studies.
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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: longitudinal, randomized block RCT with repeated measures
Masking: None (open label)
Enrolment: 299 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03416010
Sponsor's protocol ID: 2017B0425
Other IDs: 1R01MD012770-01A1
Acronym: A-RCT
Status last verified: Mar 2025
First submitted: 14 Nov 2017
Last updated: 18 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Melnyk BM, Gennaro S, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper A, Aviles MM. Improving Postpartum Mental Health and Healthy Lifestyle Behaviors in Women of Color Who Are Pregnant and Experiencing Depression, Anxiety, and Stress Through Group Prenatal Care: A Randomized Controlled Trial. J Midwifery Womens Health. 2026 Jun 23. doi: 10.1111/jmwh.70154. Online ahead of print.
PubMed 42338028
Gennaro S, Melnyk BM, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper AR, Aviles MM. Effects of Two Group Prenatal Care Interventions on Mental Health: An RCT. Am J Prev Med. 2024 May;66(5):797-808. doi: 10.1016/j.amepre.2024.01.005. Epub 2024 Feb 5.
PubMed 38323949

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Emotional Disturbances trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women: A-RCT
ClinicalTrials.gov ID: NCT03416010
Acronym / sponsor ID: A-RCT / 2017B0425
Conditions: Emotional Disturbances, Depression, Pregnancy Late, Post-Partum Depression, Anxiety, Nutritional Deficiency
Keywords: emotional distress pregnancy disparities minority depression
Study type: Interventional
Recruitment status: Completed
Enrolment: 299 participants (actual)
Lead sponsor: Ohio State UniversityUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), New York University, Jacobi Medical Center, Boston College, University of Arizona, Drexel University, National Institute on Minority Health and Health Disparities (NIMHD), University of South Florida
Study start: 5 Mar 2018 (actual)
Primary completion: 20 Apr 2023 (actual)
Study completion: 20 Apr 2023 (actual)
First posted: 30 Jan 2018 (actual)
Results: Posted 18 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: longitudinal, randomized block RCT with repeated measures

Arm	Type	Receives
Control	No intervention	–In addition to standard prenatal care the PregnancyPlus attention control group for 6 weeks will receive 1.5 hours of ACOG-designed patient education pamphlets. Material will include prenatal and post-partum education.. Dr. Gennaro will conduct the training of the attention control group midwives. The same protocol for assessing fidelity for COPE-P also will be used for assessing fidelity to the attention control intervention
Intervention	Active comparator	Behavioral: COPE-PIn addition to standard prenatal care the COPE-P intervention group will also receive 1.5 hours each week for 6 weeks the cognitive-behavior skills building program driven by CBT as the theoretical framework by health care providers trained in COPE-P by Dr. Melnyk. The content of the COPE program is driven by the literature review, the theoretical framework, previous studies of COPE interventions with mothers of preterm infants and prior work with pregnant minority women by our team.

Who may qualify

Ages: 18 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Pregnant women between the ages of 18-40 years old
Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks
Self-identified as either Black or Hispanic
Able to read and speak English.
The child participants born to the participants will have their record accessed for data collection.

Key exclusion criteria (2 listed)

Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy.
Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.

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
COPE-PSession 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave). Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones. Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses. Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication. Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle.	Behavioural	Intervention

Primary outcome

Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Healthy Lifestyle Beliefs Scale survey will be administered at each of the in-person meetings. This scale taps beliefs about various facets of maintaining a healthy lifestyle. This 16-item is scored on a five point Likert-type scale that ranging from 1 strongly disagree to 5 strongly agree. The minimum score is 16 and the maximum score is 80. The higher the score the higher the beliefs of maintaining a healthy lifestyle.
Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
The Generalized Anxiety Scale (GAD-7) is a 7-item survey which measures anxiety will be administered at each of the in-person meetings. The GAD-7 is a 7-item, 4-point Likert-type scale ranging from (0) Not at all to (3). Scores range from 0 to 21, with higher scores indicating greater functional impairment related to the patient's experience of anxiety. A score greater than or equal to 10 indicates moderate and higher anxiety and will be used in this study,
Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
The Healthy Lifestyle Behaviors Scale survey will be administered at each of the in-person meetings. Participants respond to each of the 15 items (e.g., I exercised regularly; I talked about my worries) on a 5-point Likert-type scale that ranges from 1 strongly disagree to 5 strongly agree. The minimum score is 15 and the maximum score is 75. The higher the score the higher the healthy lifestyle behaviors are practiced.
Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
The Edinburgh Postnatal Depression Scale (EPDS) is a scale measuring depressive symptoms will be administered at each of the in-person meetings. The Edinburgh Postnatal Depression Scale is a 10 item self-report perinatal depression questionnaire. The scale asks participants to describe how they have felt in the previous week. Unlike other depression screening tools, the EPDS excludes questions regarding somatic symptoms of pregnancy and has been found to be equivalent to a structured interview in determining prevalence of depression. Scores range from 0-30 with higher scores signifying higher severity of depressive symptoms. A cut-off score of 10 on the EPDS will be used in this study to indicate moderate depressive symptoms.
Change Self-reported Stress at Timepoint 0 to Timepoint 3
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
The Perceived Stress Scale (PSS) is a scale measuring stress will be administered at each of the in-person meetings. This scale is a standardized measure of global stress designed to elicit the degree to which respondents find their lives unpredictable, uncontrollable, and overloading (three central components of stress). The minimum score is 0 and the maximum score is 40. A higher score is correlated with a higher amount of stress. A score of 20 or greater is the high stress cut-off and will be used in this study.

14 secondary outcomes

Birth Weight
Time frame: T2= 6-8 week postpartum visit
Breastfeeding Initiation
Time frame: T2= 6-8 week postpartum visit
Breastfeeding Duration
Time frame: T3 = at 6 month well baby visit
Mode of Delivery
Time frame: T2= 6-8 week postpartum visit
Nutritional Intake
Time frame: Timepoint 0 (<19 weeks gestation), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Level of Exercise
Time frame: T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Gestational Age at Birth
Time frame: T2= 6-8 week postpartum visit
Weight
Time frame: Timepoint 0 (<19 weeks gestation)
Participant Body Mass Index (BMI)
Time frame: Timepoint 0 (Baseline at screening), T1 = 31 gestational weeks, T2= 6-8 week postpartum visit, T3 = at 6 month well baby visit
Participant Height
Time frame: Timepoint 0 (Baseline at screening)
Group Prenatal Care Acceptability
Time frame: T1=31 gestational weeks
Program Evaluation: Delivery Method
Time frame: Timepoint 3, approximately 6 months postpartum
COPE-P Acceptability
Time frame: Timepoint 2 (6 to 8 weeks postpartum)
Program Evaluation
Time frame: Timepoint 3, approximately 6 months postpartum

Results and safety

Results posted to the registry on 18 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control	122	111
Intervention	177	145

Primary outcome: Change in Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3

Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit). Mean (Standard Error). Unit: units on a scale

Measure	Control n = 122	Intervention n = 177
Timepoint 0	59.044 (0.736)	59.349 (0.615)
Timepoint 1	64.972 (0.823)	64.234 (0.720)
Timepoint 2	63.683 (0.880)	64.614 (0.744)
Timepoint 3	63.328 (0.853)	63.852 (0.744)

Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p = 0.009, two-way ANOVA

Population analysed: All participants who completed data collection at respective timepoints.

Primary outcome: Change in Self-reported Anxiety Level From Timepoint 0 to Timepoint 3

Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit). Mean (Standard Error). Unit: units on a scale

Measure	Control n = 122	Intervention n = 177
Timepoint 0	8.647 (0.507)	9.018 (0.329)
Timepoint 1	5.500 (0.507)	5.447 (0.444)
Timepoint 2	3.358 (0.526)	4.114 (0.459)
Timepoint 3	3.853 (0.522)	4.398 (0.459)

Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA

Population analysed: All participants who completed respective timepoints.

Primary outcome: Change in Self-reported Healthy Lifestyle Behaviors From Timepoint 0 to Timepoint 3

Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit). Mean (Standard Error). Unit: units on a scale

Measure	Control n = 122	Intervention n = 177
Timepoint 0	49.506 (0.903)	50.669 (0.730)
Timepoint 1	56.194 (0.981)	56.783 (0.868)
Timepoint 2	53.677 (1.032)	57.267 (0.897)
Timepoint 3	55.692 (1.032)	56.209 (0.897)

Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA

Population analysed: All participants who completed data collection at respective timepoints.

Primary outcome: Change in Self-reported Depressive Symptoms From Timepoint 0 to Timepoint 3

Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit). Mean (Standard Error). Unit: units on a scale

Measure	Control n = 122	Intervention n = 177
Timepoint 0	13.042 (0.435)	12.855 (0.362)
Timepoint 1	7.000 (0.560)	7.776 (0.490)
Timepoint 2	6.119 (0.580)	6.545 (0.506)
Timepoint 3	6.662 (0.576)	6.818 (0.506)

Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA
Control vs Intervention: p <0.001, two-way ANOVA

Population analysed: All participants completing data collection at respective timepoints.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control	0 of 122 (0%)	6 of 122 (4.9%)	0 of 122
Intervention	3 of 177 (1.7%)	6 of 177 (3.4%)	0 of 177

Limitations and caveats (from the sponsor): The COVID-19 pandemic impacted delivery of care requiring changes to methodology and impacting recruitment. Virtual sessions and timepoints were utilized, limiting data collection (e.g. measured weight vs participant report), the efficacy of Fitbit use (less frequent clinic visits resulted in less reminders to charge devices and lack of syncing at in-person sessions). Recruitment target was not met and attrition exceeded expectations leading to fewer participants analyzed than expected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42338028Melnyk BM, Gennaro S, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper A, Aviles MM. Improving Postpartum Mental Health and Healthy Lifestyle Behaviors in Women of Color Who Are Pregnant and Experiencing Depression, Anxiety, and Stress Through Group Prenatal Care: A Randomized Controlled Trial. J Midwifery Womens Health. 2026 Jun 23. doi: 10.1111/jmwh.70154. Online ahead of print.
Derived from this study: PubMed 38323949Gennaro S, Melnyk BM, Szalacha LA, Gibeau AM, Hoying J, O'Connor CM, Cooper AR, Aviles MM. Effects of Two Group Prenatal Care Interventions on Mental Health: An RCT. Am J Prev Med. 2024 May;66(5):797-808. doi: 10.1016/j.amepre.2024.01.005. Epub 2024 Feb 5.
Individual participant dataSharing planned: No

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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.

Bernadette Melnyk, PhD principal investigator

Ohio State University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing COPE-P in people with Emotional Disturbances and Depression, run by Ohio State University at 3 sites 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 5 inclusion and 2 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 18 Mar 2025). 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 Self-reported Healthy Lifestyle Beliefs Timepoint 0 to Timepoint 3 (time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03416010, which also lists 2 linked publications.

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 18 Mar 2025.