Postpartum DisorderP-PODNCT07071025
Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention
A study testing Preventing Postpartum Onset Distress (P-POD) and Anxiety Education (ANX-ED) in people with Postpartum Disorder, run by West Virginia University at 1 site in United States.
Trial summary
Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called "Preventing Postpartum Onset Distress", or P-POD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postpartum Disorder
- What is being tested?
- Preventing Postpartum Onset Distress (P-POD) and Anxiety Education (ANX-ED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2025to Dec 2027
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant and entering second trimester
- In a romantic relationship
- Partner must be agreeable to participate
- State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139
Who cannot join
- -Must speak English
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
Life Sciences Building
Morgantown, West Virginia, 26506
Shari A Steinman, PhD, (304) 293-2001, michelle.roleyroberts@mail.wvu.edu
About this study
Postpartum anxiety disorders are the most prevalent postpartum psychiatric conditions. The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called "Preventing Postpartum Onset Distress", or P-POD. The overarching goal of this study is to conduct a randomized control trial of P-POD, an online program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. Investigators will test the effects of P-POD compared to an anxiety education control intervention on risk factors for perinatal anxiety and assess mothers' anxiety symptoms, relationships with their partners, and relationships with their infants at 8-weeks postpartum. Eligible women and their partners will be consented at the start of the second trimester of pregnancy. Couples will be randomized into either the P-POD (active) or ANX-ED (control) intervention. Couples will then begin to work through the ten intervention modules: seven modules for women, at a recommended rate of one per week, and three modules for partners, at a recommended rate of no more than one per week. Women will complete brief weekly phone "coaching calls" to encourage module completion, ensure understanding of material, and answer any content-related or technical questions. Ten weeks after the pre-intervention assessment, women will complete the post-intervention assessment (same measures as pre-assessment).
- Conditions
- Postpartum Disorder
- Being tested
- Preventing Postpartum Onset Distress (P-POD), Anxiety Education (ANX-ED)
- Medical subject headings
- Puerperal Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing Postpartum Onset Distress (P-POD)Behavioural
P-POD contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules are designed to educate pregnant women about perinatal anxiety (psychoeducation), teach women to change their thinking patterns (cognitive restructuring), and guide women through testing their dysfunctional beliefs and fears (behavioral experiments). Each of these modules engage the pregnant woman in various self-guided exercises to consolidate the lessons learned. In addition, three partner-directed modules are designed to educate partners about perinatal anxiety, coach partners on providing emotional and social supports to pregnant women at risk for perinatal anxiety, and prepare partners for developmentally normative changes in their relationships following birth. Modules are designed to be completed weekly during the second trimester.
Anxiety Education (ANX-ED)Behavioural
ANX-ED educates women and their partners about seven anxiety and related disorders. ANX-ED contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules and three partner-directed modules will educate participants about generalized anxiety disorder, social anxiety disorder, panic disorder, specific phobia, obsessive-compulsive disorder, and posttraumatic stress disorder. Specifically, modules will include the diagnostic criteria, prevalence, and etiology of the disorders. They will also include animated examples of mothers experiencing the disorders described in each module. Each module engages the pregnant woman (or partner) in various self-guided exercises to consolidate the material learned.
| Study group | Role | What they receive |
|---|---|---|
| Preventing Postpartum Onset Distress (P-POD) | Experimental | P-POD is an online self-guided program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. Receives: Behavioral: Preventing Postpartum Onset Distress (P-POD) |
| Anxiety Education (ANX-ED) | Placebo comparator | ANX-ED will be adapted from an already-established in-person anxiety education control condition and will be modified to an Internet-based, self-guided program that serves as an attention control to P-POD. Receives: Behavioral: Anxiety Education (ANX-ED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)
Change in STAI-Trait score. This is a 20-item self-report used to assess dispositional levels of anxiety. It is widely used, sensitive to treatment, has strong psychometric properties, and includes items that would be relevant to pregnant women. The STAI-Trait Total Score will be used before and after P-POD to assess change in prenatal trait anxiety. The STAI-Trait total score ranges from 20 to 80. Higher numbers represent more anxiety (worse outcome).
Measured: Change from Baseline to Week 10
Change in Obsessive Beliefs Questionnaire (OBQ)
Change in Obsessive Beliefs Questionnaire (OBQ) score. This measure assesses dysfunctional beliefs related to OCD in 44 items on a 7-point Likert-type scale, with items summed; higher scores indicate more dysfunctional beliefs. The OBQ has strong psychometric properties and has demonstrated sensitivity to treatment with pregnant women.
Measured: Change from Baseline to Week 10
Secondary outcomes (9)
Change in Perinatal Interpretations Questionnaire (PIQ)
The PIQ will be administered to assess change in negative interpretations. This measure asks participants to read and imagine themselves in two scenarios (e.g., not checking on baby while he/she sleeps) and then rate the likelihood of eight interpretations related to each scenario (e.g., "your baby is not safe") on a 5-point Likert-type response scale. The 16 items are summed, higher scores indicate more negative perinatal interpretations.
Measured: Change from Baseline to Week 10
Change in Social Provisions Checklist (SPC)
The SPC will be administered to assess change in partner support. This measure asks participants to rate the extent to which they receive different benefits (e.g., emotional closeness) from their romantic partner. It consists of 30 items on a 5-point Likert-type scale; items are summed and higher scores indicate more perceived support. The SPC has strong internal reliability and construct validity.
Measured: Change from Baseline to 8-weeks postpartum
Overall Anxiety Severity and Impairment Scale (OASIS)
The OASIS will be administered to assess severity of postpartum anxiety. This 5-item self-report of anxiety symptom severity and impairment has strong reliability, convergent validity, and discriminant validity in both nonclinical and clinical samples, is sensitive to treatment and has been used with perinatal women. Items are scored on a 5-point scale and summed; higher scores are indicative of higher symptom severity and impairment.
Measured: 8-weeks postpartum
Dimensional Obsessive-Compulsive Scale (DOCS)
The DOCS will be administered to assess severity of postpartum OCD symptoms. This 20-item self-report of OCD symptom severity has good internal consistency, construct validity, discriminant validity, and sensitivity to treatment, and has been recommended for use in pregnant women. Items are rated on a 5-point Likert-type scale and are summed; higher numbers are indicative of higher symptom severity.
Measured: 8-weeks postpartum
Edinburgh Postpartum Depression Scale (EPDS)
The EPDS will be administered to assess severity of postpartum depression. This 10-item screening tool assesses postpartum depression symptoms in perinatal women and has shown strong evidence for validity and reliability. Items are scored on a 4-point scale and summed; higher scores indicate higher severity of depression symptoms.
Measured: 8-weeks postpartum
Couple Satisfaction Index-4 (CSI-4)
The CSI-4 will be administered to assess relationship satisfaction of both the woman and partner. This index assesses satisfaction in relationships through one item with a 6-point Likert scale and three items with a 5-point Likert scale. Strong reliability, construct validity, and convergent validity has been demonstrated. The CSI-4 items are summed, with higher numbers suggesting more relationship satisfaction.
Measured: 8-weeks postpartum
Postpartum Bonding Questionnaire (PBQ)
The PBQ will be administered to assess mother-infant bonding. This measure contains 25 items assessing maternal perceptions of bonding with their infant on a 6-point Likert-type scale. It includes the following subscales: impaired bonding, rejection and pathological anger, infant-focused anxiety, incipient abuse. The PBQ has strong reliability and has good concurrent validity with maternal mental health indicators.
Measured: 8-weeks postpartum
Five Minute Speech Sample (FMSS)
Participants are recorded (via Zoom). The participant is given the following instructions: "I'd like to hear your thoughts about [baby's name] in your own words and without my interrupting you with any questions or comments. When I ask you to begin, I'd like you to speak for 5 minutes, telling me what kind of a baby [baby's name] is and how the two of you get along together. After you have begun to speak, I prefer not to answer any questions. Are there any questions you would like to ask me before we begin?". The recording is coded by 2 independent research assistants. Researchers code for the following categories of statements: quality of initial statement, quality of relationship with baby, emotional over-involvement, and criticism. A randomly selected 20% of recordings will be double coded to assess interrater reliability.
Measured: 8-weeks postpartum
Qualitative Interview
We will use a Qualitative Description approach, which results in a rich description of experiences or perceptions of participants, using language from the collected data through low-inference (or data-near) interpretations during data analysis. We plan to interview approximately 50 women (25 per condition), though we will code interviews in batches and stop recruitment following thematic saturation. Content analysis (inductive approach) will be used to systematically reduce data into coded units that are clustered into categories according to shared characteristics. Qualitative data analysis software (NVivo 12) will be used for data management and coding purposes.
Measured: 8-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postpartum DisorderStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michelle Roley-Roberts, West Virginia University
- Investigators
- Michelle Roley Roberts, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07071025
- Sponsor's protocol ID
- 2210663965
- Other IDs
- R15HD109689
- Acronym
- P-POD
- Status last verified
- Jul 2025
- First submitted
- 8 Jul 2025
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Perinatal Anxiety: Testing an Internet-delivered Intervention
- ClinicalTrials.gov ID
- NCT07071025
- Acronym / sponsor ID
- P-POD / 2210663965
- Conditions
- Postpartum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Collaborators
- University of Vermont, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 17 Jul 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 anxiety disorders are the most prevalent postpartum psychiatric conditions. The purpose of this study is to evaluate the Internet-delivered postpartum anxiety and obsessive-compulsive disorder (OCD) prevention program, called "Preventing Postpartum Onset Distress", or P-POD. The overarching goal of this study is to conduct a randomized control trial of P-POD, an online program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. Investigators will test the effects of P-POD compared to an anxiety education control intervention on risk factors for perinatal anxiety and assess mothers' anxiety symptoms, relationships with their partners, and relationships with their infants at 8-weeks postpartum. Eligible women and their partners will be consented at the start of the second trimester of pregnancy. Couples will be randomized into either the P-POD (active) or ANX-ED (control) intervention. Couples will then begin to work through the ten intervention modules: seven modules for women, at a recommended rate of one per week, and three modules for partners, at a recommended rate of no more than one per week. Women will complete brief weekly phone "coaching calls" to encourage module completion, ensure understanding of material, and answer any content-related or technical questions. Ten weeks after the pre-intervention assessment, women will complete the post-intervention assessment (same measures as pre-assessment).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preventing Postpartum Onset Distress (P-POD) | Experimental | Behavioral: Preventing Postpartum Onset Distress (P-POD)P-POD is an online self-guided program designed to reduce and prevent perinatal anxiety in at-risk women in West Virginia. |
| Anxiety Education (ANX-ED) | Placebo comparator | Behavioral: Anxiety Education (ANX-ED)ANX-ED will be adapted from an already-established in-person anxiety education control condition and will be modified to an Internet-based, self-guided program that serves as an attention control to P-POD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant and entering second trimester
- In a romantic relationship
- Partner must be agreeable to participate
- State Trait Anxiety Inventory-Trait Total ≥ 44 and/or Obsessive Beliefs Questionnaire-44 Total ≥ 139
Key exclusion criteria (1 listed)
- -Must speak English
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 |
|---|---|---|
| Preventing Postpartum Onset Distress (P-POD)P-POD contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules are designed to educate pregnant women about perinatal anxiety (psychoeducation), teach women to change their thinking patterns (cognitive restructuring), and guide women through testing their dysfunctional beliefs and fears (behavioral experiments). Each of these modules engage the pregnant woman in various self-guided exercises to consolidate the lessons learned. In addition, three partner-directed modules are designed to educate partners about perinatal anxiety, coach partners on providing emotional and social supports to pregnant women at risk for perinatal anxiety, and prepare partners for developmentally normative changes in their relationships following birth. Modules are designed to be completed weekly during the second trimester. | Behavioural | Preventing Postpartum Onset Distress (P-POD) |
| Anxiety Education (ANX-ED)ANX-ED educates women and their partners about seven anxiety and related disorders. ANX-ED contains ten interactive and didactic modules lasting approximately 30 minutes each. Seven mother-directed modules and three partner-directed modules will educate participants about generalized anxiety disorder, social anxiety disorder, panic disorder, specific phobia, obsessive-compulsive disorder, and posttraumatic stress disorder. Specifically, modules will include the diagnostic criteria, prevalence, and etiology of the disorders. They will also include animated examples of mothers experiencing the disorders described in each module. Each module engages the pregnant woman (or partner) in various self-guided exercises to consolidate the material learned. | Behavioural | Anxiety Education (ANX-ED) |
Primary outcome
Change in State-Trait Anxiety Inventory-Trait (STAI-Trait)
Time frame: Change from Baseline to Week 10
Change in STAI-Trait score. This is a 20-item self-report used to assess dispositional levels of anxiety. It is widely used, sensitive to treatment, has strong psychometric properties, and includes items that would be relevant to pregnant women. The STAI-Trait Total Score will be used before and after P-POD to assess change in prenatal trait anxiety. The STAI-Trait total score ranges from 20 to 80. Higher numbers represent more anxiety (worse outcome).
Change in Obsessive Beliefs Questionnaire (OBQ)
Time frame: Change from Baseline to Week 10
Change in Obsessive Beliefs Questionnaire (OBQ) score. This measure assesses dysfunctional beliefs related to OCD in 44 items on a 7-point Likert-type scale, with items summed; higher scores indicate more dysfunctional beliefs. The OBQ has strong psychometric properties and has demonstrated sensitivity to treatment with pregnant women.
9 secondary outcomes
Change in Perinatal Interpretations Questionnaire (PIQ)
Time frame: Change from Baseline to Week 10
Change in Social Provisions Checklist (SPC)
Time frame: Change from Baseline to 8-weeks postpartum
Overall Anxiety Severity and Impairment Scale (OASIS)
Time frame: 8-weeks postpartum
Dimensional Obsessive-Compulsive Scale (DOCS)
Time frame: 8-weeks postpartum
Edinburgh Postpartum Depression Scale (EPDS)
Time frame: 8-weeks postpartum
Couple Satisfaction Index-4 (CSI-4)
Time frame: 8-weeks postpartum
Postpartum Bonding Questionnaire (PBQ)
Time frame: 8-weeks postpartum
Five Minute Speech Sample (FMSS)
Time frame: 8-weeks postpartum
Qualitative Interview
Time frame: 8-weeks postpartum
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 17 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Postpartum Disorder
Recruiting
The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
RecruitingPhase 4
AtorvaStatin Postpartum and Reduction of Cardiovascular risK
Hypertensive Disorders of Pregnancy, Preeclampsia
Not yet recruiting
A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Active, not recruitingPhase 2/3
Resources, Inspiration, Support and Empowerment (RISE) for Black Pregnant Women
Pregnancy Related, Pregnancy Complications
Not yet recruitingObservational study
AI-Enabled Wearable Monitoring for Detection of Postpartum Depression and Anxiety
Postpartum Depression (PPD), Postpartum Anxiety
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.
Michelle Roley Roberts, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventing Postpartum Onset Distress (P-POD) and Anxiety Education (ANX-ED) in people with Postpartum Disorder, run by West Virginia University 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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 17 Jul 2025. 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. Some participants in this study may receive a placebo. 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 Michelle Roley Roberts, PhD ((304) 293-2001, michelle.roleyroberts@mail.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in State-Trait Anxiety Inventory-Trait (STAI-Trait) (time frame: Change from Baseline to Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.