Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 352
- 试验地点
- 1
- 主要终点
- Symptoms of postpartum depression
研究概览
简要总结
Postpartum depression (PPD) is a common and serious condition affecting 9.5% of women in high-income countries, and around 8% in Denmark. It shares core features with major depression, including low mood, loss of interest, and impaired functioning. Untreated PPD can persist for months, negatively impacting maternal well-being, child development, and family dynamics. In Denmark, systematic screening using the Edinburgh Postnatal Depression Scale (EPDS) is standard practice, but access to PPD treatment varies widely across municipalities.
Cognitive behavioral therapy (CBT) is the most effective psychological intervention for perinatal depression, yet limited availability and long wait times create barriers to access to care. Internet-based CBT (iCBT) offers a scalable, cost-effective alternative that can be delivered flexibly at home. Evidence supports the efficacy of self-guided iCBT for depression, though challenges such as high dropout rates have been reported. International trials in Norway, Portugal, Iran, South Korea, and the US have shown promising results for iCBT in perinatal populations. Some recent iCBT based interventions have also incorporated elements of Acceptance and Commitment Therapy (ACT) - which emphasizes psychological flexibility via mindfulness-based acceptance and values-driven action-and have demonstrated efficacy in reducing postpartum depression symptoms. These kinds of interventions (either iCBT or iCBT + ACT) have not yet been tested and evaluated in Denmark.
This clinical trial aims to evaluate whether adding an iCBT intervention with elements from ACT (iCARE) to treatment as usual (TAU) is more effective than TAU alone in reducing depressive symptoms in mothers with symptoms of PPD.
Moreover, a qualitative process evaluation of the iCARE will explore implementation, acceptability, and mechanisms of impact. Its primary aim is to understand how participants experience the iCARE intervention and TAU, focusing on implementation fidelity, acceptability, and contextual influences. The secondary aim is to explore perceived mechanisms of change (e.g., cognitive, emotional, behavioral) and barriers/facilitators to engagement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Given birth within 6 months
- •Edinburgh Postnatal Depression Scale (EPDS) score above 7
- •Access to the internet
排除标准
- •Do not understand Danish language,
- •Substance abuse or dependence
- •Alcohol abuse, defined by a weekly consumption of alcohol exceeding 10 units
- •A diagnosis of schizophrenia, other psychotic disorders or in immediate need of psychiatric treatment.
研究组 & 干预措施
Internet-based therapy (iCARE) and treatment as usual
The iCARE program is a self-guided iCBT intervention that also incorporates selected exercises and approaches from ACT. The iCARE program consists of four core modules and four optional modules. Together, these exercises aim to enhance psychological flexibility, reduce negative thinking, and promote well-being in daily life.
The core modules focus on self-care and mindfulness (Module 1), identifying and reframing unrealistic expectations with self-compassion (Module 2), increasing positive experiences and countering self-critical thoughts (Module 3), and recognizing and challenging thinking traps (Module 4). The additional optional modules provide strategies for practicing being present, communicating needs and asking for support, bonding with the baby, and coping with scary thoughts.
干预措施: Internet-based therapy (iCARE) and treatment as usual (Behavioral)
Treatment as usual
In Denmark, there is large variation in the available prevention and treatment municipalities offers for women experiencing symptoms of PPD. Some municipalities offer specialized psychological support and support groups, while others provide only basic follow-up by health nurses. Women can also be referred to their general practitioner, who can provide free ongoing follow-up and prescribe antidepressant medication if needed. Alternatively, it is possible to be referred to a privately practicing psychologist, usually with some out-of-pocket cost.
干预措施: Treatment as usual (TAU) (Other)
结局指标
主要结局
Symptoms of postpartum depression
时间窗: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)
The Edinburgh Postnatal Depression Scale (EPDS) is a validated screening questionnaire that measures symptoms of postnatal depression, such as low mood, anxiety, and loss of enjoyment, over the past week. It helps identify mothers who may need further assessment or support but does not provide a diagnosis. The primary outcome is the between-group difference in change from baseline to 2-month follow-up in EPDS score (range 0-30; higher scores indicate more severe symptoms). A clinically meaningful response is defined as a ≥3-point reduction from baseline. Participants will be categorized as responders/non-responders, and proportions will be reported for each group.
次要结局
- Symptoms of anxiety(Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint))
- Health-related disability and functioning(Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint))
- Automatic negative thoughts/negative self-statements(At 2-months (primary endpoint))
- Parental Stress(At 2-months (primary endpoint))
研究者
Trine Munk-Olsen
Professor
University of Southern Denmark