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

Not Applicable

Recruiting

• Conditions: Stress; Postpartum Depressive Disorder; Postpartum Anxiety

• Registration Number: NCT06610552
• Lead Sponsor: Marta Marciniak

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.

Study Timeline

• Study Start: 2024-02-01
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-10-30
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DASS (Depression, Anxiety, and Stress Scales)	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
PDSS (Postpartum Depression Screening Scale)	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 Outcome Measures

Name	Time	Method
CERQ (Cognitive Emotion Regulation Questionnaire)	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
PASS-C (Positive Appraisal Style scale - content)	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
BRS (Brief Resilience Scale)	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
BSS-RI (Birth Satisfaction Scale - Revised Indicator)	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
PBQ (Postpartum Bonding Scale)	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
mARM (mobile Agnew Relationship Measure)	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
uMARS (user version of the Mobile Application Rating Scale)	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
MFA (Maternal-Fetal Attachment Scale)	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
GSE (General Self-Efficacy Scale)	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
Adherence	Collected passively during app use period (4 weeks)	the number of interactions with the app by each of the participants

Trial Locations

Locations (1)

University of Zurich; 🇨🇭 Zurich, Switzerland