Implementation of a Psychoeducational Intervention in New Mothers

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

Study 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)

Eligibility

Primary outcome measure(s)

• 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 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 — 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.

Trial sites (2)

Other trials for the same condition