Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety (POWERLY app)

Real-life Implementation Randomized Clinical Trial Assessing Effectiveness of 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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Postpartum Anxiety; Postpartum Depressive Disorder
• Intervention / Treatment: Behavioral: Powerly

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marta A. Marciniak, PhD; Phone Number: 0031-107545276; Email: marciniak@essb.eur.nl

Study Locations

• Switzerland
  • Zurich, Switzerland
    • Recruiting
    • University of Zurich
    • Contact: Dorjee Bargeman; Phone Number: +41 (0)58 384 23 50; Email: dorjee.bargeman@uzh.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 behavioral activation exercises.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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)
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

Other Outcome Measures

Outcome Measure	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)	includes nine items to measure specifically positive mental well-being	Collected only during baseline measurement

Collaborators and Investigators

• Sponsor: Marta Marciniak
• Collaborators: University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: mobile health; pregnancy; stress; digital health; postpartum depression; ecological momentary intervention; postpartum anxiety
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Behavioral Symptoms; Mood Disorders; Puerperal Disorders; Anxiety Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: UZH24.08.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized questionnaire (self-report) data will be shared in an open science repository, for instance Open Science Framework.
• IPD Sharing Time Frame: The data will be shared after the study completion (published along with manuscripts from the trial), without the end date.
• IPD Sharing Access Criteria: The data will be publicly available.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No