An interventional study of COPE-P in Emotional Disturbances, Depression and Pregnancy Late, sponsored by Ohio State University. Completed at 3 sites in United States. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-18.
Sponsored by Ohio State University · Not applicable, Interventional, and Basic science
Among 28 studies in Affective Symptoms with a site in United States — 4 open to participants now, 4 under way, none of them phase 3. Affective Symptoms · United States.
Among the 28 studies in Affective Symptoms with a site in United States, this one is the 5th largest by enrollment of the 27 interventional ones, is one of 4 that started in 2018, is one of 24 with no phase, and was the 10th registered.
85 studies on the registry are indexed under Affective Symptoms; 20 are open to participants now.
This study's enrollment of 299 is above the median of 80 across 63 interventional studies indexed under Affective Symptoms.
Browse Affective Symptoms studies →4 of the 28 studies in Affective Symptoms with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 11 Affective Symptoms studies recruiting now, 4 (36%) set no upper age limit and 7 (64%) stop at 75 or younger; 5 take children under 18; 4 take healthy volunteers.
This study: 18 Years to 40 Years · female · healthy volunteers too.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 4 started in 2018.
Median enrollment 50 across the 27 interventional studies, 53 across the 1 observational. Of the 23 that completed or were terminated, 4 (17%) have results posted.
1 of 28 have an industry lead sponsor. The 10 most frequent:
Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Ohio State University has 1 study filed under Affective Symptoms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 28 studies in Affective Symptoms with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
Behavioral: COPE-P
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.
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.
Time frame: 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,
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Timepoint 0 (<19 weeks gestation) to Timepoint 3 (6 month well child visit)
Birth Weight
record of birth weight as recorded in patient's medical file
Time frame: 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.
Time frame: 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).
Time frame: T3 = at 6 month well baby visit
Mode of Delivery
(C/S, Vaginal, Forceps/Vacuum)
Time frame: 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).
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
Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
Time frame: 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
Time frame: T2= 6-8 week postpartum visit
Weight
weight in pounds
Time frame: 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
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
height in feet and inches will be recorded at each of the in person meetings
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Timepoint 3, approximately 6 months postpartum
Participant recruitment was initiated March 5, 2018, at two medical clinic sites in urban clinics in two states. A third medical clinic site was added to support recruitment in 2019. Recruitment closed April 11, 2022.
| Milestone | Control | Intervention |
|---|---|---|
| Started | 122 | 177 |
| Completed | 111 | 145 |
| Not completed | 11 | 32 |
| Withdrew: Medically excluded or aged out prior to initiating intervention | 11 | 32 |
| Milestone | Control | Intervention |
|---|---|---|
| Started | 111 | 145 |
| Completed | 73 | 95 |
| Not completed | 38 | 50 |
| Withdrew: Withdrawal by subject | 27 | 38 |
| Withdrew: Lost to follow-up | 11 | 12 |
| Milestone | Control | Intervention |
|---|---|---|
| Started | 73 | 95 |
| Completed | 71 | 92 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Milestone | Control | Intervention |
|---|---|---|
| Started | 71 | 92 |
| Completed | 68 | 86 |
| Not completed | 3 | 6 |
| Withdrew: Lost to follow-up | 1 | 3 |
| Withdrew: Missing data | 2 | 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.
| units on a scale | Control | Intervention |
|---|---|---|
| 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 |
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,
| units on a scale | Control | Intervention |
|---|---|---|
| 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 |
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.
| units on a scale | Control | Intervention |
|---|---|---|
| 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 |
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.
| units on a scale | Control | Intervention |
|---|---|---|
| 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 |
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.
| units on a scale | Control | Intervention |
|---|---|---|
| Timepoint 0 | 21.857 ± 0.562 | 21.971 ± 0.468 |
| Timepoint 1 | 15.278 ± 0.723 | 15.596 ± 0.633 |
| Timepoint 2 | 12.448 ± 0.750 | 13.420 ± 0.654 |
| Timepoint 3 | 13.971 ± 0.744 | 14.193 ± 0.654 |
record of birth weight as recorded in patient's medical file
| grams | Control | Intervention |
|---|---|---|
| Birth Weight | 3139.9 ± 740.3 | 3310.1 ± 732.6 |
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.
| Participants | Control | Intervention |
|---|---|---|
| Breastfeeding Initiation | 64 | 83 |
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).
| Participants | Control | Intervention |
|---|---|---|
| Breastfeeding Duration | 18 | 34 |
(C/S, Vaginal, Forceps/Vacuum)
| Participants | Control | Intervention |
|---|---|---|
| Vaginal Delivery | 52 | 52 |
| Assisted Vaginal Delivery (forceps, vacuum) | 0 | 4 |
| Cesarean Delivery | 17 | 29 |
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).
| units on a scale | Control | Intervention |
|---|---|---|
| Timepoint 0 | 3.955 ± 0.088 | 4.070 ± 0.073 |
| Timepoint 1 | 4.264 ± 0.098 | 4.298 ± 0.085 |
| Timepoint 2 | 4.075 ± 0.101 | 4.200 ± 0.090 |
| Timepoint 3 | 4.169 ± 0.103 | 4.173 ± 0.092 |
Fitbit Flex 2 Accelerometer report data: data from Fitbit Flex 2 report will be collected at each of the in-person meetings
No measurements were reported for this outcome.
Gestational age at birth will be collected as reported on patient's medical chart
| weeks | Control | Intervention |
|---|---|---|
| Gestational Age at Birth | 39.0 ± 1.9 | 38.8 ± 1.8 |
weight in pounds
| pounds | Control | Intervention |
|---|---|---|
| Weight | 174.3 ± 47.2 | 171.0 ± 46.7 |
derived calculation from weight and height values reported at each of the in person meetings
| kg/m^2 | Control | Intervention |
|---|---|---|
| Timepoint 0 | 29.4 ± 7.6 | 29.2 ± 7.5 |
| Timepoint 1 | 33.1 ± 7.8 | 31.8 ± 7.9 |
| Timepoint 2 | 31.2 ± 7.3 | 29.7 ± 7.2 |
| Timepoint 3 | 31.0 ± 8.0 | 30.4 ± 8.0 |
height in feet and inches will be recorded at each of the in person meetings
| inches | Control | Intervention |
|---|---|---|
| Participant Height | 63.9 ± 3.0 | 63.9 ± 3.0 |
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".
| Participants | Control | Intervention |
|---|---|---|
| Strongly Disagree | 0 | 0 |
| Disagree | 0 | 0 |
| Neutral | 1 | 0 |
| Agree | 15 | 16 |
| Strongly Agree | 42 | 40 |
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.
| Participants | Control | Intervention |
|---|---|---|
| First choice 1:1 in person | 9 | 6 |
| First choice 1:1 by telehealth | 3 | 2 |
| First choice in small group in person | 9 | 17 |
| First choice in small group by telehealth | 9 | 6 |
| Missing data | 1 | 0 |
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.
| score on a scale | Intervention |
|---|---|
| COPE-P Acceptability | 94.05 ± 9.06 |
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.
| Participants | Control | Intervention |
|---|---|---|
| Program helpful: yes | 31 | 30 |
| Program helpful: no | 0 | 1 |
Collected over From baseline (<19 weeks gestation) to collection of Timepoint 3, approximately 6 months postpartum.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | 0/122 (0%) | 0/122 (0%) | 6/122 (4.9%) |
| Intervention | 0/177 (0%) | 3/177 (1.7%) | 6/177 (3.4%) |
| Event | Control | Intervention |
|---|---|---|
| Fetal DemisePregnancy, puerperium and perinatal conditions | 0/122 | 2/177 |
| Suicide AttemptPsychiatric disorders | 0/122 | 1/177 |
| Event | Control | Intervention |
|---|---|---|
| Preterm BirthPregnancy, puerperium and perinatal conditions | 6/71 | 6/92 |
| Age, Categorical(Participants) | Control | Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 122 | 177 | 299 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control | Intervention | Total |
|---|---|---|---|
| Mean | 26.2 ± 5.3 | 26.4 ± 5.3 | 26.3 ± 5.3 |
| Sex: Female, Male(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Female | 122 | 177 | 299 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 56 | 68 | 124 |
| Not Hispanic or Latino | 49 | 91 | 140 |
| Unknown or Not Reported | 17 | 18 | 35 |
| Race (NIH/OMB)(Participants) | Control | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 76 | 118 | 194 |
| White | 6 | 15 | 21 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 40 | 44 | 84 |
| Region of Enrollment(participants) | Control | Intervention | Total |
|---|---|---|---|
| United States | 122 | 177 | 299 |
| Enrolled in School(Participants) | Control | Intervention | Total |
|---|---|---|---|
| Enrolled | 103 | 35 | 138 |
| Not Enrolled | 18 | 140 | 158 |
| Did not respond | 1 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2018 to primary completion in Apr 2023, 61 months.
Results were first posted in Mar 2025, 1 year 10 months after primary completion.
Of 44 non-industry interventional studies with no phase under Affective Symptoms, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 40. This study's 61 months is above that.
Counting every sponsor, half of 44 studies reached it within 21 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.