Evaluating the Effectiveness of an Internet-based Therapy (iCARE) to Treat Symptoms of Postpartum Depression

Обзор

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.

Вмешательства

• Поведенческое 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 expe
• Другое Treatment as usual (TAU)
  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

Первичные конечные точки

• Symptoms of postpartum depression [Срок оценки: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)]

Вторичные конечные точки (4)

• Symptoms of anxiety [Срок оценки: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)]
• Health-related disability and functioning [Срок оценки: Baseline At 2 months (primary endpoint) At 6 months (secondary endpoint)]
• Automatic negative thoughts/negative self-statements [Срок оценки: At 2-months (primary endpoint)]
• Parental Stress [Срок оценки: At 2-months (primary endpoint)]

Критерии участия

Критерии включения

• Given birth within 6 months
• Edinburgh Postnatal Depression Scale (EPDS) score above 7
• ≥age 18
• Access to the internet

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Дания · 1 центр

• Research Unit of Child and Adolescent Psychiatry, Department of Clinical Research, Univers — Odense

Идентификаторы

NCT: NCT07384273 · 16-0302-23 · 23/15327 · 12.250 · 514-1114/25-3000 · 16-0302-23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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