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

NCT ID: NCT06610552

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-10-30

Brief Summary

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.

Conditions

Stress; Postpartum Depressive Disorder; Postpartum Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention - Powerly

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.

Group Type: EXPERIMENTAL

Powerly

Intervention Type: 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.

Care as usual

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 behavioral activation exercises.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Zurich

OTHER

Sponsor Role: collaborator

Marta Marciniak

OTHER

Sponsor Role: lead

Responsible Party

Marta Marciniak

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Zurich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Marta A. Marciniak, PhD

Role: CONTACT

marciniak@essb.eur.nl

0031-107545276

Facility Contacts

Dorjee Bargeman

Role: primary

dorjee.bargeman@uzh.ch

+41 (0)58 384 23 50

References

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.

Reference Type: DERIVED

PMID: 40607107 (View on PubMed)

Other Identifiers

UZH24.08.23

Identifier Type: -

Identifier Source: org_study_id