Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety

Официальное название

Real-life Implementation Randomized Clinical Trial Assessing Effectiveness of Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety

Обзор

The goal of this clinical trial is to determine if the Powerly app can help prevent postpartum depression and anxiety in healthy pregnant women. The main questions it aims to answer are: * Does the Powerly app reduce postpartum depression and anxiety? * Does it improve emotion regulation and maternal bonding with a child? Researchers will compare two groups: one using the Powerly app and the other receiving care as usual (CAU) to see if the app leads to better mental health outcomes. Participants will: * Use the Powerly app for four weeks (if in the intervention group). * Complete mental health assessments before the study, after four weeks, and six weeks postpartum.

Подробное описание

Pregnancy is a period of significant emotional and physical changes, with up to 30% of expecting mothers experiencing high stress. After birth, around 15-20% of new mothers suffer from postpartum depression, and 25-35% experience anxiety. Despite broad availability of mobile apps aimed at these challenges, none of them have been rigorously tested through clinical studies. To fill this gap, we developed Powerly, a science-based mobile app designed to help prevent postpartum depression and anxiety.

In this study, 140 healthy pregnant women will be randomly assigned to one of two groups: one will use the Powerly app for four weeks, while the other will receive care as usual (CAU). Powerly is grounded in cognitive behavioral therapy (CBT) and personalized to the individual's needs, with input from healthcare professionals and pregnant women. We will collect information on participants\' mental health at three points: before they start using the app, after four weeks of app use / CAU, and six weeks after giving birth. The app's effectiveness will be evaluated by examining improvements in mental health outcomes, such as reduced rates of postpartum depression and anxiety, better emotion regulation, and stronger maternal bonding with a baby.

Вмешательства

• Поведенческое Powerly
  Powerly is a mental well-being mobile app, in which pregnant women can track their mood and level of stress, and receive personalized psychological modules to increase their mental health and well-being. By integrating evidence-based content and cognitive behavioral techniques with insights from pregnant and postpartum individuals and health professionals, Powerly offers a comprehensive psychological support including reappraisal, mental imagery, gratitude, mindfulness, self-efficacy and behavio

Первичные конечные точки

• DASS (Depression, Anxiety, and Stress Scales) [Срок оценки: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
• PDSS (Postpartum Depression Screening Scale) [Срок оценки: Collected only at second follow-up measurement 6 weeks postpartum]

Вторичные конечные точки (10)

• CERQ (Cognitive Emotion Regulation Questionnaire) [Срок оценки: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
• PASS-C (Positive Appraisal Style scale - content) [Срок оценки: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
• BRS (Brief Resilience Scale) [Срок оценки: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
• BSS-RI (Birth Satisfaction Scale - Revised Indicator) [Срок оценки: Collected only at second follow-up measurement 6 weeks postpartum]
• PBQ (Postpartum Bonding Scale) [Срок оценки: Collected only at second follow-up measurement 6 weeks postpartum]
• mARM (mobile Agnew Relationship Measure) [Срок оценки: Collected only at first follow-up measurement after 4 weeks of study]
• uMARS (user version of the Mobile Application Rating Scale) [Срок оценки: Collected only at first follow-up measurement after 4 weeks of study]
• MFA (Maternal-Fetal Attachment Scale) [Срок оценки: From baseline measurement until first follow-up measurement after 4 weeks of study]
• GSE (General Self-Efficacy Scale) [Срок оценки: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
• Adherence [Срок оценки: Collected passively during app use period (4 weeks)]

Критерии участия

Критерии включения

• being between 24 and 32 weeks pregnant,
• owning an iPhone,
• having sufficient fluency in German language

Критерии исключения

• high-risk pregnancies,
• history of substance abuse and psychiatric disorders such as bipolar disorder, schizophrenia, or other psychotic disorders,
• current use of professional face-to-face psychotherapeutic support,
• participation in other clinical trials or interventions at the same time

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• University of Zurich — Zurich

Публикации

• Marciniak MA, Rohde J, Yuen KSL, Binder H, Walter H, Wieser MJ, Kalisch R, Roelofs K, Kleim B. Development of Powerly, unguided mobile app intervention preventing postpartum depression and anxiety & study protocol of randomized clinical trial. Internet Interv. 2025 Jun 16;41:100843. doi: 10.1016/j.invent.2025.100843. eCollection 2025 Sep. PMID 40607107

Идентификаторы

NCT: NCT06610552 · UZH24.08.23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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