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| Name | Class |
|---|---|
| University of Zurich | OTHER |
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - Powerly | Experimental | Participants in the intervention group will complete baseline questionnaires and receive instructions on how to download Powerly. They will use the app daily for 28 days, at least once per day, and will be invited to complete the questionnaires again, and once more six weeks postpartum. |
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| Care as usual | No Intervention | Participants in the CAU group will complete baseline questionnaires and be informed that they will receive access to Powerly six weeks postpartum. They will be invited to complete the questionnaires again 28 days later, and once more six weeks postpartum. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Powerly | Behavioral | 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 behavioral activation exercises. |
| Measure | Description | Time Frame |
|---|---|---|
| DASS (Depression, Anxiety, and Stress Scales) | a validated set of brief scales consisting of 21 items used to measure the severity of depression, anxiety, and stress symptoms | From baseline measurement until the second follow-up measurement at 6 weeks postpartum |
| PDSS (Postpartum Depression Screening Scale) | a comprehensive tool comprising 35 items designed to identify symptoms of postpartum depression, including aspects such as sleep and eating disturbances, insecurity, emotional lability, guilt, and shame | Collected only at second follow-up measurement 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| CERQ (Cognitive Emotion Regulation Questionnaire) | it comprises 36 items assessing the strategies individuals employ to manage their emotions, including positive reappraisal, acceptance, rumination, and putting into perspective, among others | From baseline measurement until the second follow-up measurement at 6 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| BFI-10 (Big Five Inventory-10) | it assesses the five major dimensions of personality (openness, conscientiousness, extraversion, agreeableness, and neuroticism) with 10 items | Collected only during baseline measurement |
| PMH (Positive Mental Health scale) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marta A. Marciniak, PhD | Contact | 0031-107545276 | marciniak@essb.eur.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich | Recruiting | Zurich | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40607107 | Derived | 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. |
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Anonymized questionnaire (self-report) data will be shared in an open science repository, for instance Open Science Framework.
The data will be shared after the study completion (published along with manuscripts from the trial), without the end date.
The data will be publicly available.
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| PASS-C (Positive Appraisal Style scale - content) |
comprises of 14 items and measures person's general style of evaluating stressors |
| From baseline measurement until the second follow-up measurement at 6 weeks postpartum |
| BRS (Brief Resilience Scale) | it measures resilience operationalized as an outcome of the process of adaptation to adversity, using 5 questions | From baseline measurement until the second follow-up measurement at 6 weeks postpartum |
| BSS-RI (Birth Satisfaction Scale - Revised Indicator) | assesses the subjective experience of labor, including aspects of anxiety, stress, feelings of control, and support, using 6 items | Collected only at second follow-up measurement 6 weeks postpartum |
| PBQ (Postpartum Bonding Scale) | the 25-item questionnaire measures the quality of the bond between the mother and her infant. It includes factors such as the general bonding factor, anxiety about the baby, and rejection | Collected only at second follow-up measurement 6 weeks postpartum |
| mARM (mobile Agnew Relationship Measure) | it evaluates the therapeutic alliance between the app and the user through 25 items. It covers topics such as confidence, openness, user initiative, and partnership | Collected only at first follow-up measurement after 4 weeks of study |
| uMARS (user version of the Mobile Application Rating Scale) | tool used for assessment of the feasibility of the app, including aspects of engagement, aesthetics, functionality, and the quality of information provided in the EMI, with 20 questions | Collected only at first follow-up measurement after 4 weeks of study |
| MFA (Maternal-Fetal Attachment Scale) | the 24-item scale evaluates the bond between mother and fetus during pregnancy. It includes questions about interactions with the fetus, attributing characteristics to the fetus, and role-taking, among others | From baseline measurement until first follow-up measurement after 4 weeks of study |
| GSE (General Self-Efficacy Scale) | it evaluates an individual optimistic self-belief in their capability to handle difficult tasks, challenges, and adversities, through 10 items | From baseline measurement until the second follow-up measurement at 6 weeks postpartum |
| Adherence | the number of interactions with the app by each of the participants | Collected passively during app use period (4 weeks) |
includes nine items to measure specifically positive mental well-being
| Collected only during baseline measurement |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |