Study plan for a randomized controlled trial using prenatal emotional-cognitive training to decrease the likelihood of postpartum depression (PACT study)
A new trial, titled the Prenatal Affective Cognitive Training (PACT) study, is underway to investigate the potential prophylactic effects of prenatal affective cognitive training on postpartum depression (PPD) in pregnant women at heightened risk. The trial, registered on ClinicalTrials.gov NCT06046456, was updated on July 08, 2024.
The PACT intervention, based on emerging evidence for the efficacy of affective cognitive training approaches in depression, includes cognitive bias modification, attention bias modification, mindfulness-inspired emotion regulation exercises, and working memory training. Pregnant women at high risk of PPD will be randomized to either prenatal affective cognitive training (PACT) or care as usual (CAU).
Participants randomized to PACT will complete five individual computerized and virtual reality-based training sessions over 5 weeks. The primary outcome is the difference between intervention arms in the incidence of PPD, assessed with an interview 6 months after birth. The severity of depressive symptoms will also be assessed weekly online during the first 6 weeks postpartum.
The study will enroll a total of 292 pregnant women, 146 at high risk and 146 at low risk of postpartum depression. Pregnant women will undergo comprehensive assessments of affective cognitive processing, clinical depressive symptoms, and complete questionnaires at baseline.
The aim of this randomized controlled intervention trial is to investigate the potential prophylactic effects of prenatal affective cognitive training for pregnant women at heightened risk of PPD. The results of the study could influence future early prophylactic interventions for pregnant women at high risk of PPD.
Cognitive-behavioral therapy (CBT), which aligns closely with cognitive training concepts, is strongly recommended as an effective method for both prevention and treatment of postpartum depression. These therapies can help women manage negative thought patterns and emotional challenges, potentially preventing the onset or worsening of PPD. Emotional self-care techniques used during pregnancy, such as mindfulness and journaling, also contribute benefits by enhancing emotional regulation and stress management, which are relevant components of prenatal affective cognitive training.
Early psychological interventions that address anxiety, depression, and obsessive-compulsive symptoms during the peripartum period are critical because untreated mood disorders can significantly affect maternal and child outcomes. Screening and early cognitive/affective intervention may reduce these risks. While digital and lifestyle interventions indirectly show promise in improving postpartum mental health outcomes, PACT specifically targets cognitive and emotional regulation skills before birth, offering prophylactic benefits by enhancing emotional self-regulation and coping skills, reducing anxiety and depressive symptoms during pregnancy, and facilitating early identification and management of emerging mood symptoms.
If successful, PACT intervention could be a feasible, non-invasive prophylactic strategy during pregnancy. Direct empirical studies specifically naming or investigating "PACT" would be required for definitive confirmation, but current evidence strongly supports cognitive-affective preventive training as beneficial in lowering PPD incidence in high-risk groups.
- The Prenatal Affective Cognitive Training (PACT) study, based on rising evidence from science, investigates the potential preventive effects of eye tracking technologies in health-and-wellness interventions, specifically mental-health therapies-and-treatments for pregnant women at risk of developing postpartum depression (PPD).
- The study's findings could significantly impact future health-and-wellness initiatives, as PACT, which includes cognitive bias modification, attention bias modification, mindfulness-inspired emotion regulation exercises, and working memory training, aims to enhance cognitive-behavioral therapy (CBT) approaches by focusing on women's health and emotional self-care techniques.
- As digital and lifestyle interventions emerge as promising strategies for improving postpartum mental health outcomes, this trial contains the potential to advance our understanding of prenatal affective cognitive training, offering preventive benefits for high-risk women, and possibly revolutionizing women's health and mental-health therapies-and-treatments.
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