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StressPOWERLY appNCT06610552

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

A study testing Powerly in people with Stress and Postpartum Depressive Disorder, run by Marta Marciniak at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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?… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
Powerly
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteSwitzerland
Study dates
1 Feb 2024to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marta A. Marciniak, PhD contact

0031-107545276

marciniak@essb.eur.nl

Switzerland1 site, 1 recruiting

  • University of Zurich

    Zurich

    Dorjee Bargeman, +41 (0)58 384 23 50, dorjee.bargeman@uzh.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: 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.
Read the 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.

Being tested
Powerly
Keywords
pregnancy, postpartum depression, postpartum anxiety, stress, digital health, mobile health, ecological momentary intervention
Medical subject headings
Depression, Postpartum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PowerlyBehavioural

    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.

Study groups in NCT06610552
Study groupRoleWhat they receive
Intervention - PowerlyExperimentalParticipants 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.
Receives: Behavioral: Powerly
Care as usualNo interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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

    Measured: Collected only at second follow-up measurement 6 weeks postpartum

Secondary outcomes (10)

  1. 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

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

  2. PASS-C (Positive Appraisal Style scale - content)

    comprises of 14 items and measures person's general style of evaluating stressors

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

  3. BRS (Brief Resilience Scale)

    it measures resilience operationalized as an outcome of the process of adaptation to adversity, using 5 questions

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

  4. 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

    Measured: Collected only at second follow-up measurement 6 weeks postpartum

  5. 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

    Measured: Collected only at second follow-up measurement 6 weeks postpartum

  6. 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

    Measured: Collected only at first follow-up measurement after 4 weeks of study

  7. 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

    Measured: Collected only at first follow-up measurement after 4 weeks of study

  8. 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

    Measured: From baseline measurement until first follow-up measurement after 4 weeks of study

  9. 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

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

  10. Adherence

    the number of interactions with the app by each of the participants

    Measured: Collected passively during app use period (4 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2024
  2. Study start1 Feb 2024
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06610552
Sponsor's protocol ID
UZH24.08.23
Acronym
POWERLY app
Status last verified
May 2025
First submitted
20 Sep 2024
Last updated
20 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized questionnaire (self-report) data will be shared in an open science repository, for instance Open Science Framework.

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.

    PubMed 40607107

Questions about this trial

What is this clinical trial studying?

A study testing Powerly in people with Stress and Postpartum Depressive Disorder, run by Marta Marciniak at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marta A. Marciniak, PhD (0031-107545276, marciniak@essb.eur.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DASS (Depression, Anxiety, and Stress Scales) (time frame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06610552, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.

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