Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06610552

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Stress Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Anxiety Postpartum Depressive Disorder Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. DASS (Depression, Anxiety, and Stress Scales)

    Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum

    a validated set of brief scales consisting of 21 items used to measure the severity of depression, anxiety, and stress symptoms

  2. PDSS (Postpartum Depression Screening Scale)

    Time frame: Collected only at second follow-up measurement 6 weeks postpartum

    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

Secondary outcomes

  1. CERQ (Cognitive Emotion Regulation Questionnaire)

    Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum

    it comprises 36 items assessing the strategies individuals employ to manage their emotions, including positive reappraisal, acceptance, rumination, and putting into perspective, among others

  2. PASS-C (Positive Appraisal Style scale - content)

    Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum

    comprises of 14 items and measures person's general style of evaluating stressors

  3. BRS (Brief Resilience Scale)

    Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum

    it measures resilience operationalized as an outcome of the process of adaptation to adversity, using 5 questions

  4. BSS-RI (Birth Satisfaction Scale - Revised Indicator)

    Time frame: Collected only at second follow-up measurement 6 weeks postpartum

    assesses the subjective experience of labor, including aspects of anxiety, stress, feelings of control, and support, using 6 items

  5. PBQ (Postpartum Bonding Scale)

    Time frame: Collected only at second follow-up measurement 6 weeks postpartum

    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

  6. mARM (mobile Agnew Relationship Measure)

    Time frame: Collected only at first follow-up measurement after 4 weeks of study

    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

  7. uMARS (user version of the Mobile Application Rating Scale)

    Time frame: Collected only at first follow-up measurement after 4 weeks of study

    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

  8. MFA (Maternal-Fetal Attachment Scale)

    Time frame: From baseline measurement until first follow-up measurement after 4 weeks of study

    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

  9. GSE (General Self-Efficacy Scale)

    Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum

    it evaluates an individual optimistic self-belief in their capability to handle difficult tasks, challenges, and adversities, through 10 items

  10. Adherence

    Time frame: Collected passively during app use period (4 weeks)

    the number of interactions with the app by each of the participants

Other outcomes

  1. BFI-10 (Big Five Inventory-10)

    Time frame: Collected only during baseline measurement

    it assesses the five major dimensions of personality (openness, conscientiousness, extraversion, agreeableness, and neuroticism) with 10 items

  2. PMH (Positive Mental Health scale)

    Time frame: Collected only during baseline measurement

    includes nine items to measure specifically positive mental well-being

Study contacts

Contact information is provided by the study sponsor or research team.

Marta A. Marciniak, PhD

CONTACT

[email protected]

0031-107545276

Sponsors and collaborators

Lead sponsor

Marta Marciniak

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Acronym: POWERLY app

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.