Implementation of a Psychoeducational Intervention in New Mothers
- Conditions
- Depression, PostpartumAnxiety
- Interventions
- Behavioral: WWWT psychoeducative intervention
- Registration Number
- NCT06512025
- Lead Sponsor
- Alba Roca
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
- 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
- If are unable to complete the questionnaires due to language or literacy barriers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description WWWT psychoeducative intervention WWWT psychoeducative intervention Participants will received the postpartum routine usual care plus two psychoeducative intervention WWWT sessions at the Sexual and Reproductive Health Service (ASSIR).
- Primary Outcome Measures
Name Time Method Mental Disorders 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 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 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.
- Secondary Outcome Measures
Name Time Method Parenting self-regulation Baseline, 3 and 6 months follow-up 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.
Maternal postpartum bonding Baseline, 3 and 6 months follow-up 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.
Satisfaction survey Intervention group participants immediately after completing the WWWT psychoeducative group. 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.Marital Adjustment Baseline, 3 and 6 months follow-up 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.
Trial Locations
- Locations (2)
Unitat de Salut Mental Perinatal (USMP) de l'Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Atenció a la salut sexual i reproductiva (ASSIR) de l'Àrea Integral de Salut Barcelona Esquerra (AIS-BE)
🇪🇸Barcelona, Spain