Implementation of a Psychoeducational Intervention in New Mothers

NCT06512025 | Recruiting

• 1 other identifier: 193/C/2022
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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 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)

Conditions

Depression, Postpartum; Anxiety

Keywords

Postpartum Period; Prevention; Preventive Health Care; Psychoeducation; Primiparity; Female

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  Baseline, 3 and 6 months follow-up

Secondary Outcomes (4)

• Maternal postpartum bonding

  Baseline, 3 and 6 months follow-up

• Parenting self-regulation

  Baseline, 3 and 6 months follow-up

• Marital Adjustment

  Baseline, 3 and 6 months follow-up

• Satisfaction survey

  Intervention group participants immediately after completing the WWWT psychoeducative group.

Other Outcomes (9)

• Partner Violence

  Baseline, 3 and 6 months follow-up

• Alcohol use

  Baseline, 3 and 6 months follow-up

• Childhood trauma

  Baseline

Study Arms (2)

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).

Behavioral: WWWT psychoeducative intervention

Interventions

WWWT psychoeducative intervention BEHAVIORAL

"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).

WWWT psychoeducative intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• If are unable to complete the questionnaires due to language or literacy barriers

Sponsors & Collaborators

• Alba Roca: lead
• Fundació La Marató de TV3: collaborator
• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: collaborator
• Universitat Autonoma de Barcelona: collaborator

Study Sites (2)

Unitat de Salut Mental Perinatal (USMP) de l'Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

NOT YET RECRUITING

Atenció a la salut sexual i reproductiva (ASSIR) de l'Àrea Integral de Salut Barcelona Esquerra (AIS-BE)

Barcelona, Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Depression, Postpartum; Anxiety Disorders

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Alba Roca, Doctor

  Fundacion Clinic per a la Recerca Biomédica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alba Roca, Doctor

CONTACT

+34653092959; aroca1@clinic.cat

Noelia Fernández, Graduate

CONTACT

+34691045604; fernandez15@recerca.clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: A CONSORT-compliant parallel group randomized controlled trial will be conducted

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 22, 2024
• Study Start: November 8, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)