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Recruiting NCT06610552

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

No phase Interventional Stress Postpartum Depressive Disorder Postpartum Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Powerly.
Who it may be relevant to
Registry conditions: Stress, Postpartum Depressive Disorder, Postpartum Anxiety. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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

Primary outcome measures

  • DASS (Depression, Anxiety, and Stress Scales) [Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
  • PDSS (Postpartum Depression Screening Scale) [Time frame: Collected only at second follow-up measurement 6 weeks postpartum]
Secondary outcome measures (10)
  • CERQ (Cognitive Emotion Regulation Questionnaire) [Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
  • PASS-C (Positive Appraisal Style scale - content) [Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
  • BRS (Brief Resilience Scale) [Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
  • BSS-RI (Birth Satisfaction Scale - Revised Indicator) [Time frame: Collected only at second follow-up measurement 6 weeks postpartum]
  • PBQ (Postpartum Bonding Scale) [Time frame: Collected only at second follow-up measurement 6 weeks postpartum]
  • mARM (mobile Agnew Relationship Measure) [Time frame: Collected only at first follow-up measurement after 4 weeks of study]
  • uMARS (user version of the Mobile Application Rating Scale) [Time frame: Collected only at first follow-up measurement after 4 weeks of study]
  • MFA (Maternal-Fetal Attachment Scale) [Time frame: From baseline measurement until first follow-up measurement after 4 weeks of study]
  • GSE (General Self-Efficacy Scale) [Time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum]
  • Adherence [Time frame: Collected passively during app use period (4 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

Switzerland · 1 center
  • University of Zurich — Zurich

Publications

  • 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

Identifiers

NCT: NCT06610552 · UZH24.08.23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗