Depression, PostpartumEQEPNCT06512025
Implementation of a Psychoeducational Intervention in New Mothers
A study testing WWWT psychoeducative intervention in people with Depression, Postpartum and Anxiety, run by Alba Roca at 2 sites in Spain.
Trial summary
The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Depression, Postpartum, Anxiety
- What is being tested?
- WWWT psychoeducative intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Nov 2024to Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primiparous women
- Given birth a healthy, full-term baby in the preceding 2 weeks
- Receiving postpartum healthcare at Atenció a la salut sexual i reproductiva (ASSIR) of Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
- Over 18 years of age
- Give consent to participate in the study
Who cannot join
- If are unable to complete the questionnaires due to language or literacy barriers
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Not yet recruiting
Unitat de Salut Mental Perinatal (USMP) de l'Hospital Clínic de Barcelona
Barcelona, Barcelona, 08036
Alba Roca-Lecumberri, Doctor, +34653092959, aroca1@clinic.cat
Noelia Fernández-Jarabo, Graduate, +34691045604, fernandez15@recerca.clinic.cat
- Recruiting
Atenció a la salut sexual i reproductiva (ASSIR) de l'Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
Barcelona, Barcelona
Judit Pelegrí, Diplomat, jpelegri.bcn.ics@gencat.cat
Julia M Cid, Diplomat
About this study
Official title: Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers
The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals.
Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers.
Read more
Participants will:
- Take baseline questionnaires at 2-4 weeks postpartum
- Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum
- Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up
- Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)
- Conditions
- Depression, Postpartum, Anxiety
- Being tested
- WWWT psychoeducative intervention
- Keywords
- Postpartum Period, Prevention, Preventive Health Care, Psychoeducation, Primiparity, Female
- Medical subject headings
- Depression, Postpartum, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WWWT psychoeducative interventionBehavioural
"What Were We Thinking" (WWWT) is a highly structured, interactive, gender-informed, couples-based, psycho-educational program for parents and a first newborn to promote confident parental caretaking, optimize functioning in the intimate partner relationship and improve infant care manageability.
The adaptation of the WWWT programme (Catalan and Spanish version) comprises 2 sessions, each lasting 2 hours, that will be designed for groups of 5-7 families - within the first 6 weeks postpartum -, each consisting of mother, partner (or other caregiver) and their infant(s).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Participants will received the postpartum usual care at the Sexual and Reproductive Health Service (ASSIR). |
| WWWT psychoeducative intervention | Experimental | Participants will received the postpartum routine usual care plus two psychoeducative intervention WWWT sessions at the Sexual and Reproductive Health Service (ASSIR). Receives: Behavioral: WWWT psychoeducative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Disorders
The Mini-International Neuropsychiatric Interview (MINI) is a brief structured interview designed for the detection and diagnostic guidance of major Axis I psychiatric disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) and the International Classification of Diseases, 10th Edition (ICD-10). It has an administration time of approximately 15 minutes and is divided into 16 modules, identified by letters, each corresponding to a diagnostic category.
Measured: 3 and 6 months postpartum (follow-up)
Depressive symptoms
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire that is used as a screening instrument and for research purposes. Item scores are summed up to a total score (from 0 to 30 points), with higher scores indicating a higher depressive symptom burden. At a cutoff value of 11 (EPDS ≥ 11), the sensitivity of detecting a clinically significant depression is 0.79, the specificity is 0.95, and the positive predictive value is 0.63. The scale has a good internal consistency (Cronbach's α = 0.81).
Measured: Baseline, 3 and 6 months follow-up
Depressive symptoms
The Beck Depression Inventory (BDI-II) is a 21-item self-report instrument designed to assess the severity of depressive symptomatology. In each item, the person evaluated must select the phrase that best describes their condition over the past two weeks from a list of four options, with seven alternatives in items 16 and 18. Each item is scored from 0 to 3 points, with the total score ranging from 0 to 63, with higher scores indicating a higher depressive symptom burden.
Measured: Baseline, 3 and 6 months follow-up
Anxiety symptoms
The Generalised Anxiety Disorder Screener (GAD-7) is a 7-item self-report scale used as a screening instrument measuring symptoms of generalized anxiety disorder that has been recommended as brief screening measure for perinatal anxiety. Item scores are summed up to a total score (from 0 to 21 points), with higher scores indicating a higher anxiety symptom burden. There are no cut-off points established for the Spanish version. In the original version, the authors propose a cut-off point of greater than or equal to 10. For the Spanish version, a Cronbach's alpha coefficient of 0.93 was obtained. Considering the 10-point cutoff, sensitivity values of 86.8% and specificity of 93.4% were found.
Measured: Baseline, 3 and 6 months follow-up
Secondary outcomes (4)
Maternal postpartum bonding
The Postpartum Bonding Questionnaire (PBQ) is a 25-item self-report questionnaire used to evaluate the alterations of the maternal-filial bond in the postpartum period. It includes 4 subscales, with a total of 25 items, which are rated by the mother on a Likert-type scale from 0 to 5. The subscales are general factor, rejection and pathological anger, infant-centered anxiety, and incipient maltreatment scale. The Spanish adaptation and validation has an adequate psychometrics property for use with clinical and general population of Spanish puerperal women. The PBQ could be summarized in a general factor and that the use of the total score of the scale would already be useful to detect alterations in the mother-infant bond (Cronbach's alpha reliability value of 0.90). A total score of 26 or more would indicate some type of attachment disorder, and a score of 40 or more would indicate the presence of maternal rejection or a severe attachment disorder.
Measured: Baseline, 3 and 6 months follow-up
Parenting self-regulation
The Me as a Parent scale (MaaPs) is a 16-item self-report scale used to measure the parents' perceptions of their parenting role. The scale has four theoretical sub-dimensions (Parenting Self-Efficacy; Personal Agency; Self-Management; and Self-Sufficiency), each containing four items scored on a 5-point agreement scale, with a total scale score range of 16-80. Higher scores indicate a higher parent's self-perceived competence and efficacy.
Measured: Baseline, 3 and 6 months follow-up
Marital Adjustment
The Escala de Ajuste Diádico (EAD-13) is a 13-item self-report short version of the Dyadic Adjustment Scale (DAS) used to assess the degree of harmony or adjustment between the members of the couple's relationship through 3 dimensions: consensus (capacity, resources and skills to reach agreements or find joint solutions to problems), satisfaction (level of well-being, happiness and commitment in the couple) and cohesion (degree of involvement of one member of the couple with the other). Item scores are summed up to a total score (from 12 to 75 points), with higher scores indicating increased marital adjustment. The scale has shown adequate psychometric properties to be applied in the Spanish context, finding a Cronbach's alpha reliability value of 0.81.
Measured: Baseline, 3 and 6 months follow-up
Satisfaction survey
Satisfaction survey is made up of Likert-type questions from 0 to 5 points
(1 = completely disagree, 5 = completely agree) and open questions to measure participants' satisfaction with the WWWT psychoeducational intervention in terms of accessibility, comprehensibility, acceptability and usefulness, and identify needs or possible difficulties in its implementation.
Measured: Intervention group participants immediately after completing the WWWT psychoeducative group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start8 Nov 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression, PostpartumStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Model description
- A CONSORT-compliant parallel group randomized controlled trial will be conducted
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alba Roca
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Universitat Autonoma de Barcelona
- Responsible party
- Sponsor-investigator, Alba Roca, Fundacion Clinic per a la Recerca Biomédica
- Investigators
- Alba Roca, Doctor, Principal investigator, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512025
- Sponsor's protocol ID
- 193/C/2022
- Acronym
- EQEP
- Status last verified
- Feb 2025
- First submitted
- 15 Jul 2024
- Last updated
- 26 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation and Implementation of a Psychoeducational Intervention to Prevent Postpartum Depression and Anxiety Disorders in New Mothers
- ClinicalTrials.gov ID
- NCT06512025
- Acronym / sponsor ID
- EQEP / 193/C/2022
- Conditions
- Depression, Postpartum, Anxiety
- Keywords
- Postpartum Period, Prevention, Preventive Health Care, Psychoeducation, Primiparity, Female
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Alba RocaUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3, Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina, Universitat Autonoma de Barcelona
- Study start
- 8 Nov 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 22 Jul 2024 (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.
The goal of this clinical trial is to implement and examine the clinical effectiveness in a randomized study of the Catalan and Spanish versions of the culturally adapted "What Were We Thinking (WWWT)" psychoeducational intervention in primary care services, with the aim of preventing and reducing the prevalence of postpartum mental illness in new mothers. Additionally, the trial will assess the acceptability and accessibility of the intervention by families and professionals.
Researchers will compare "Usual Care" (standard postnatal care provided by professionals from the Sexual and Reproductive Health Service) with "Intervention group" (usual care plus two psychoeducative intervention WWWT sessions) to see if the "WWWT intervention" is better than "Usual Care" at preventing postpartum depression and anxiety disorders in new mothers.
Participants will:
- Take baseline questionnaires at 2-4 weeks postpartum
- Take usual care or usual care plus two psychoeducative intervention WWWT sessions within the first 6 weeks postpartum
- Take the same questionnaires used in baseline plus a semi-structured interview to diagnose major mental disorder (all participants) at 3 and 6 months follow-up
- Take a brief anonymous self-report survey (only those participants taking the WWWT intervention)
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A CONSORT-compliant parallel group randomized controlled trial will be conducted
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Participants will received the postpartum usual care at the Sexual and Reproductive Health Service (ASSIR). |
| WWWT psychoeducative intervention | Experimental | Behavioral: WWWT psychoeducative interventionParticipants will received the postpartum routine usual care plus two psychoeducative intervention WWWT sessions at the Sexual and Reproductive Health Service (ASSIR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primiparous women
- Given birth a healthy, full-term baby in the preceding 2 weeks
- Receiving postpartum healthcare at Atenció a la salut sexual i reproductiva (ASSIR) of Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
- Over 18 years of age
- Give consent to participate in the study
Key exclusion criteria (1 listed)
- If are unable to complete the questionnaires due to language or literacy barriers
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 |
|---|---|---|
| WWWT psychoeducative intervention"What Were We Thinking" (WWWT) is a highly structured, interactive, gender-informed, couples-based, psycho-educational program for parents and a first newborn to promote confident parental caretaking, optimize functioning in the intimate partner relationship and improve infant care manageability. The adaptation of the WWWT programme (Catalan and Spanish version) comprises 2 sessions, each lasting 2 hours, that will be designed for groups of 5-7 families - within the first 6 weeks postpartum -, each consisting of mother, partner (or other caregiver) and their infant(s). | Behavioural | WWWT psychoeducative intervention |
Primary outcome
Mental Disorders
Time frame: 3 and 6 months postpartum (follow-up)
The Mini-International Neuropsychiatric Interview (MINI) is a brief structured interview designed for the detection and diagnostic guidance of major Axis I psychiatric disorders as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) and the International Classification of Diseases, 10th Edition (ICD-10). It has an administration time of approximately 15 minutes and is divided into 16 modules, identified by letters, each corresponding to a diagnostic category.
Depressive symptoms
Time frame: Baseline, 3 and 6 months follow-up
The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report questionnaire that is used as a screening instrument and for research purposes. Item scores are summed up to a total score (from 0 to 30 points), with higher scores indicating a higher depressive symptom burden. At a cutoff value of 11 (EPDS ≥ 11), the sensitivity of detecting a clinically significant depression is 0.79, the specificity is 0.95, and the positive predictive value is 0.63. The scale has a good internal consistency (Cronbach's α = 0.81).
Depressive symptoms
Time frame: Baseline, 3 and 6 months follow-up
The Beck Depression Inventory (BDI-II) is a 21-item self-report instrument designed to assess the severity of depressive symptomatology. In each item, the person evaluated must select the phrase that best describes their condition over the past two weeks from a list of four options, with seven alternatives in items 16 and 18. Each item is scored from 0 to 3 points, with the total score ranging from 0 to 63, with higher scores indicating a higher depressive symptom burden.
Anxiety symptoms
Time frame: Baseline, 3 and 6 months follow-up
The Generalised Anxiety Disorder Screener (GAD-7) is a 7-item self-report scale used as a screening instrument measuring symptoms of generalized anxiety disorder that has been recommended as brief screening measure for perinatal anxiety. Item scores are summed up to a total score (from 0 to 21 points), with higher scores indicating a higher anxiety symptom burden. There are no cut-off points established for the Spanish version. In the original version, the authors propose a cut-off point of greater than or equal to 10. For the Spanish version, a Cronbach's alpha coefficient of 0.93 was obtained. Considering the 10-point cutoff, sensitivity values of 86.8% and specificity of 93.4% were found.
4 secondary outcomes
Maternal postpartum bonding
Time frame: Baseline, 3 and 6 months follow-up
Parenting self-regulation
Time frame: Baseline, 3 and 6 months follow-up
Marital Adjustment
Time frame: Baseline, 3 and 6 months follow-up
Satisfaction survey
Time frame: Intervention group participants immediately after completing the WWWT psychoeducative group.
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 26 Feb 2025.
- 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.
Alba Roca, Doctor principal investigator
Fundacion Clinic per a la Recerca Biomédica
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WWWT psychoeducative intervention in people with Depression, Postpartum and Anxiety, run by Alba Roca at 2 sites in Spain.
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 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: looking for participants now, as of the sponsor's last update on 26 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Alba Roca, Doctor (+34653092959, aroca1@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Disorders (time frame: 3 and 6 months postpartum (follow-up)). The study lists 4 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 26 Feb 2025.