Post Partum DepressionNCT06991166
OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
A study testing Cognitive behavioral therapy (CBT) psychotherapy group/telehealth and Interpersonal therapy (IPT) psychotherapy group/telehealth in people with Post Partum Depression, run by Hackensack Meridian Health at 1 site in United States.
Trial summary
Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Cognitive behavioral therapy (CBT) psychotherapy group/telehealth and Interpersonal therapy (IPT) psychotherapy group/telehealth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2025to 1 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mother of NICU infant
- Older than age 18
- English-speaking
- Gave birth more than 24 hours ago and less than 12 months prior to enrollment
- Depression as assessed by:
- Current/Prior diagnosis of Major Depressive Disorder OR EPDS score above 10 OR EPDS score below 10 AND Endorsement of "sometimes" or "often" on item #10 on the EPDS ("I have had thoughts of harming myself")
Who cannot join
- A diagnosis of Substance Dependency or Substance Use
- Acute suicidal or infanticidal ideation
- Current psychosis
- Medical history of cognitive impairment
- Infant death of current NICU admission
- Marked non-compliance with intervention (e.g, non-attendance of more than one session during a 4-week intervention or failure to complete study assessments),
- Are in medical treatment that would prevent participation (i.e., medical treatment that requires inpatient hospitalization and thus would prevent participation of study visits.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Yeraz Markarian, PhD, 551-996-4450, Yeraz.Markarian@hmhn.org
About this study
Official title: OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers
Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby.
One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone.
This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.
- Conditions
- Post Partum Depression
- Being tested
- Cognitive behavioral therapy (CBT) psychotherapy group/telehealth, Interpersonal therapy (IPT) psychotherapy group/telehealth
- Keywords
- Post Partum Depression, Cognitive behavioral therapy, interpersonal therapy, psychotherapy, NICU
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy (CBT) psychotherapy group/telehealthBehavioural
Type of psychotherapy. CBT focuses on identifying and changing unhelpful beliefs and behavioral patterns that lead to negative emotions (e.g., depression, anxiety, grief, shame) in order to break the emotion-thought-behavior cycle
Interpersonal therapy (IPT) psychotherapy group/telehealthBehavioural
Type of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions
| Study group | Role | What they receive |
|---|---|---|
| 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention | Experimental | After the first 4-week of CBT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of IPT intervention. Receives: Behavioral: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth; Behavioral: Interpersonal therapy (IPT) psychotherapy group/telehealth |
| 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention | Experimental | After the first 4-week of IPT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of CBT intervention. Receives: Behavioral: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth; Behavioral: Interpersonal therapy (IPT) psychotherapy group/telehealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Partum Depression post initial psychotherapy
Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measures will be administered at the following timepoints:
Week 0 Baseline: At study entry prior to starting group psychotherapy in the Outpatient Behavioral Health practice Week 4: After completing the first 4-week intervention of the two-intervention sequence, prior to "crossing over"
Measured: At 4 weeks
Secondary outcomes (2)
Postpartum Depression after both types of psychotherapy
Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measure will be administered at Week 8: After completing the second 4-week intervention and completing the entire 8-week two-intervention sequence.
Measured: At 8 weeks
Postpartum Depression at follow up
Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measure will be administered at 6 months post enrollment.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2025
- Study start15 Sep 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hackensack Meridian Health
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Health Foundation
- Responsible party
- Sponsor
- Investigators
- Yeraz Markarian, PhD, Principal investigator, Hackensack Meridian Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06991166
- Sponsor's protocol ID
- Pro2024-0204
- Status last verified
- Sep 2026
- First submitted
- 19 May 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Saharoy R, Potdukhe A, Wanjari M, Taksande AB. Postpartum Depression and Maternal Care: Exploring the Complex Effects on Mothers and Infants. Cureus. 2023 Jul 4;15(7):e41381. doi: 10.7759/cureus.41381. eCollection 2023 Jul.
PubMed 37546054Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.
PubMed 27780317Wyatt T, Shreffler KM, Ciciolla L. Neonatal intensive care unit admission and maternal postpartum depression. J Reprod Infant Psychol. 2019 Jul;37(3):267-276. doi: 10.1080/02646838.2018.1548756. Epub 2018 Nov 19.
PubMed 30450956Bonacquisti A, Geller PA, Patterson CA. Maternal depression, anxiety, stress, and maternal-infant attachment in the neonatal intensive care unit. J Reprod Infant Psychol. 2020 Jul;38(3):297-310. doi: 10.1080/02646838.2019.1695041. Epub 2019 Dec 4.
PubMed 31795733Stamou G, Garcia-Palacios A, Botella C. Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review. BMC Psychol. 2018 Jun 18;6(1):28. doi: 10.1186/s40359-018-0240-5.
PubMed 29914574Stuart S, Koleva H. Psychological treatments for perinatal depression. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):61-70. doi: 10.1016/j.bpobgyn.2013.09.004. Epub 2013 Oct 7.
PubMed 24269903Burger M, Hoosain M, Einspieler C, Unger M, Niehaus D. Maternal perinatal mental health and infant and toddler neurodevelopment - Evidence from low and middle-income countries. A systematic review. J Affect Disord. 2020 May 1;268:158-172. doi: 10.1016/j.jad.2020.03.023. Epub 2020 Mar 6.
PubMed 32174474Stevenson MD, Scope A, Sutcliffe PA, Booth A, Slade P, Parry G, Saxon D, Kalthenthaler E; group cognitive behavioural therapy for postnatal depression advisory group. Group cognitive behavioural therapy for postnatal depression: a systematic review of clinical effectiveness, cost-effectiveness and value of information analyses. Health Technol Assess. 2010 Sep;14(44):1-107, iii-iv. doi: 10.3310/hta14440.
PubMed 20863477Klier CM, Muzik M, Rosenblum KL, Lenz G. Interpersonal psychotherapy adapted for the group setting in the treatment of postpartum depression. J Psychother Pract Res. 2001 Spring;10(2):124-31.
PubMed 11264336Beck, J.S.(2021) Cognitive Behavior Therapy : Basics and Beyond, Third Edition, NY: Guilford Press
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OBWELL: Evaluating the Effectiveness of an Innovative Psychotherapeutic Intervention to Treat Postpartum Depression Among High-Risk Mothers
- ClinicalTrials.gov ID
- NCT06991166
- Acronym / sponsor ID
- Pro2024-0204
- Conditions
- Post Partum Depression
- Keywords
- Post Partum Depression, Cognitive behavioral therapy, interpersonal therapy, psychotherapy, NICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Hackensack Meridian HealthUniversity, hospital or other
- Collaborators
- New Jersey Health Foundation
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 26 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postpartum Depression (PPD) is defined as depression that occurs after childbirth, with intense symptoms that last longer than "baby blues". PPD differs greatly from "baby blues", a term used to describe the typical sadness, worry and tiredness that women experience after childbirth, which often resolves within a week or two on its own. The symptoms of PPD interfere with many aspects of daily living and can have unhealthy short-term and long-term outcomes, both for the mother and baby.
One-third of women in the U.S. with PPD are identified in clinical settings, yet only half of those begin psychotherapy treatment. Unfortunately, mothers whose newborns are in the Neonatal Intensive Care Unit (NICU) are at high risk for developing PPD, necessitating early identification and evidence-based treatment. Cognitive behavioral therapy (CBT) and interpersonal therapy (IPT) are the two most effective psychotherapy treatments for PPD, yet no randomized controlled clinical trials were found that directly compared the two types of treatment or determined whether combining the two approaches is more helpful for PPD than either approach alone.
This clinical trial aims to compare the effectiveness of a 4-week intervention of either CBT or IPT for PPD in NICU mothers and to determine whether a sequential 8-week intervention (IPT then CBT, or CBT then IPT) is more beneficial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention | Experimental | Behavioral: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth, Behavioral: Interpersonal therapy (IPT) psychotherapy group/telehealthAfter the first 4-week of CBT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of IPT intervention. |
| 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention | Experimental | Behavioral: Cognitive behavioral therapy (CBT) psychotherapy group/telehealth, Behavioral: Interpersonal therapy (IPT) psychotherapy group/telehealthAfter the first 4-week of IPT intervention , participants will be administered the Peri-Intervention (Week 4) Assessment - which consists of the EPDS, Social Determinants of Health, and the Risk Factor questionnaire - and then "cross-over" to the second 4-week of CBT intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mother of NICU infant
- Older than age 18
- English-speaking
- Gave birth more than 24 hours ago and less than 12 months prior to enrollment
- Depression as assessed by:
Key exclusion criteria (7 listed)
- A diagnosis of Substance Dependency or Substance Use
- Acute suicidal or infanticidal ideation
- Current psychosis
- Medical history of cognitive impairment
- Infant death of current NICU admission
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 |
|---|---|---|
| Cognitive behavioral therapy (CBT) psychotherapy group/telehealthType of psychotherapy. CBT focuses on identifying and changing unhelpful beliefs and behavioral patterns that lead to negative emotions (e.g., depression, anxiety, grief, shame) in order to break the emotion-thought-behavior cycle | Behavioural | 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention, 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention |
| Interpersonal therapy (IPT) psychotherapy group/telehealthType of psychotherapy. IPT focuses on improving interpersonal communication and deficits, processing grief, and role transitions | Behavioural | 4-week Cognitive behavioral therapy (CBT) psychotherapy group/telehealth intervention, 4-week interpersonal therapy (IPT) psychotherapy group/telehealth intervention |
Primary outcome
Post Partum Depression post initial psychotherapy
Time frame: At 4 weeks
Quantitative assessment of treatment effectiveness in reducing PPD symptoms will be conducted with the Edinburgh Postnatal Depression Scale (EPDS), a 10-item validated self-report scale. Total scores on the EPDS range from 0 to 30, with scores 13 and above indicating depressive illness, or a high risk of developing a depressive disorder. The measures will be administered at the following timepoints: Week 0 Baseline: At study entry prior to starting group psychotherapy in the Outpatient Behavioral Health practice Week 4: After completing the first 4-week intervention of the two-intervention sequence, prior to "crossing over"
2 secondary outcomes
Postpartum Depression after both types of psychotherapy
Time frame: At 8 weeks
Postpartum Depression at follow up
Time frame: At 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 37546054Saharoy R, Potdukhe A, Wanjari M, Taksande AB. Postpartum Depression and Maternal Care: Exploring the Complex Effects on Mothers and Infants. Cureus. 2023 Jul 4;15(7):e41381. doi: 10.7759/cureus.41381. eCollection 2023 Jul.
- Background: PubMed 27780317Cox EQ, Sowa NA, Meltzer-Brody SE, Gaynes BN. The Perinatal Depression Treatment Cascade: Baby Steps Toward Improving Outcomes. J Clin Psychiatry. 2016 Sep;77(9):1189-1200. doi: 10.4088/JCP.15r10174.
- Background: PubMed 30450956Wyatt T, Shreffler KM, Ciciolla L. Neonatal intensive care unit admission and maternal postpartum depression. J Reprod Infant Psychol. 2019 Jul;37(3):267-276. doi: 10.1080/02646838.2018.1548756. Epub 2018 Nov 19.
- Background: PubMed 31795733Bonacquisti A, Geller PA, Patterson CA. Maternal depression, anxiety, stress, and maternal-infant attachment in the neonatal intensive care unit. J Reprod Infant Psychol. 2020 Jul;38(3):297-310. doi: 10.1080/02646838.2019.1695041. Epub 2019 Dec 4.
- Background: PubMed 29914574Stamou G, Garcia-Palacios A, Botella C. Cognitive-Behavioural therapy and interpersonal psychotherapy for the treatment of post-natal depression: a narrative review. BMC Psychol. 2018 Jun 18;6(1):28. doi: 10.1186/s40359-018-0240-5.
- Background: PubMed 24269903Stuart S, Koleva H. Psychological treatments for perinatal depression. Best Pract Res Clin Obstet Gynaecol. 2014 Jan;28(1):61-70. doi: 10.1016/j.bpobgyn.2013.09.004. Epub 2013 Oct 7.
- Background: PubMed 32174474Burger M, Hoosain M, Einspieler C, Unger M, Niehaus D. Maternal perinatal mental health and infant and toddler neurodevelopment - Evidence from low and middle-income countries. A systematic review. J Affect Disord. 2020 May 1;268:158-172. doi: 10.1016/j.jad.2020.03.023. Epub 2020 Mar 6.
- Background: PubMed 20863477Stevenson MD, Scope A, Sutcliffe PA, Booth A, Slade P, Parry G, Saxon D, Kalthenthaler E; group cognitive behavioural therapy for postnatal depression advisory group. Group cognitive behavioural therapy for postnatal depression: a systematic review of clinical effectiveness, cost-effectiveness and value of information analyses. Health Technol Assess. 2010 Sep;14(44):1-107, iii-iv. doi: 10.3310/hta14440.
- Background: PubMed 11264336Klier CM, Muzik M, Rosenblum KL, Lenz G. Interpersonal psychotherapy adapted for the group setting in the treatment of postpartum depression. J Psychother Pract Res. 2001 Spring;10(2):124-31.
- BackgroundBeck, J.S.(2021) Cognitive Behavior Therapy : Basics and Beyond, Third Edition, NY: Guilford Press
- 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.
Yeraz Markarian, PhD principal investigator
Hackensack Meridian Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive behavioral therapy (CBT) psychotherapy group/telehealth and Interpersonal therapy (IPT) psychotherapy group/telehealth in people with Post Partum Depression, run by Hackensack Meridian Health at 1 site 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Giuliano, LMSW (5519964450, Melissa.Giuliano@hmhn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Partum Depression post initial psychotherapy (time frame: At 4 weeks). 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 NCT06991166, which also lists 10 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 8 Sep 2026.