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

NCT06610552 | Recruiting

• 1 other identifier: UZH24.08.23
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Postpartum Depressive Disorder; Postpartum Anxiety

Keywords

pregnancy; postpartum depression; postpartum anxiety; stress; digital health; mobile health; ecological momentary intervention

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• CERQ (Cognitive Emotion Regulation Questionnaire)

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

• PASS-C (Positive Appraisal Style scale - content)

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

• BRS (Brief Resilience Scale)

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

• BSS-RI (Birth Satisfaction Scale - Revised Indicator)

  Collected only at second follow-up measurement 6 weeks postpartum

• PBQ (Postpartum Bonding Scale)

  Collected only at second follow-up measurement 6 weeks postpartum

Other Outcomes (2)

• BFI-10 (Big Five Inventory-10)

  Collected only during baseline measurement

• PMH (Positive Mental Health scale)

  Collected only during baseline measurement

Study Arms (2)

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.

Behavioral: Powerly

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.

Interventions

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.

Intervention - Powerly

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marta Marciniak: lead
• University of Zurich: collaborator

Study Sites (1)

University of Zurich

Zurich, Switzerland

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Marta A. Marciniak, PhD

CONTACT

0031-107545276; marciniak@essb.eur.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be shared after the study completion (published along with manuscripts from the trial), without the end date.
• Access Criteria: The data will be publicly available.

Locations

CH (1)