产前情感认知训练降低产后抑郁风险（PACT）：一项随机对照试验的研究方案。

Prenatal affective cognitive training to reduce the risk of postpartum depression (PACT): study protocol for a randomized controlled trial.

机构信息

The Neurocognition and Emotion in Affective Disorders Centre (NEAD), Psychiatric Centre Copenhagen, Mental Health Services in the Capital Region of Denmark, Frederiksberg, Denmark.

Department of Psychology, Faculty of Social Sciences, University of Copenhagen, Copenhagen, Denmark.

出版信息

Trials. 2024 Jul 15;25(1):478. doi: 10.1186/s13063-024-08316-1.

DOI:10.1186/s13063-024-08316-1

PMID:39010232

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11247870/

Abstract

BACKGROUND

Postpartum depression (PPD) affects 30-50% of women with a history of previous depression or bipolar disorder and 8% of women with no history of depression. Negative cognitive biases in the perception of infant cues and difficulties with emotion regulation are replicated risk factors. Current interventions focus on detecting and treating rather than preventing PPD. The aim of this randomized controlled intervention trial is therefore to investigate the potential prophylactic effects of prenatal affective cognitive training for pregnant women at heightened risk of PPD.

METHODS

The study will enrol a total of 292 pregnant women: 146 at high risk and 146 at low risk of PPD. Participants undergo comprehensive assessments of affective cognitive processing, clinical depressive symptoms, and complete questionnaires at baseline. Based on the responses, pregnant women will be categorized as either at high or low risk of PPD. High-risk participants will be randomized to either prenatal affective cognitive training (PACT) or care as usual (CAU) immediately after the baseline testing. The PACT intervention is based on emerging evidence for efficacy of affective cognitive training approaches in depression, including cognitive bias modification, attention bias modification, mindfulness-inspired emotion regulation exercises, and working memory training. Participants randomised to PACT will complete five individual computerised 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. We will also assess the severity of depressive symptoms, rated weekly online during the first 6 weeks postpartum.

DISCUSSION

The results will have implications for future early prophylactic interventions for pregnant women at heightened risk of PPD. If the PACT intervention reduces the incidence of PPD, it can become a feasible, non-invasive prophylactic strategy during pregnancy, with positive mental health implications for these women and their children.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06046456 registered 21-09-2023, updated 08-07-2024.

摘要

背景

产后抑郁症（PPD）影响 30-50%有既往抑郁或双相情感障碍病史的女性和 8%无抑郁病史的女性。对婴儿线索的负性认知偏差和情绪调节困难是可复制的风险因素。目前的干预措施侧重于检测和治疗，而不是预防 PPD。因此，这项随机对照干预试验的目的是研究产前情感认知训练对有 PPD 高风险的孕妇的潜在预防作用。

方法

该研究将共纳入 292 名孕妇：146 名高危和 146 名低危 PPD。参与者在基线时接受全面的情感认知处理、临床抑郁症状评估和完整的问卷调查。根据反应，孕妇将被分为 PPD 高风险或低风险。高危参与者将在基线测试后立即随机分为产前情感认知训练（PACT）或常规护理（CAU）。PACT 干预基于情感认知训练方法在抑郁症中的疗效的新证据，包括认知偏差修正、注意偏差修正、正念启发的情绪调节练习和工作记忆训练。随机分配到 PACT 的参与者将在 5 周内完成 5 次个体化计算机化和虚拟现实基础训练。主要结果是干预组之间产后 6 个月 PPD 发生率的差异，通过分娩后 6 个月的访谈评估。我们还将评估产后第 1-6 周每周在线评估的抑郁症状严重程度。