Clinical trial NCT06610552: Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety
Official title: Real-life Implementation Randomized Clinical Trial Assessing Effectiveness of Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress
Postpartum Depressive Disorder
Postpartum Anxiety
Keywords: pregnancy
postpartum depression
postpartum anxiety
stress
digital health
mobile health
ecological momentary intervention
Lead sponsor: Erasmus University Rotterdam
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2024-09-24
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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\&#39; 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.

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

Primary outcomes:
measure: DASS (Depression, Anxiety, and Stress Scales)
timeFrame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum
measure: PDSS (Postpartum Depression Screening Scale)
timeFrame: Collected only at second follow-up measurement 6 weeks postpartum
Secondary outcomes:
measure: CERQ (Cognitive Emotion Regulation Questionnaire)
timeFrame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum
measure: PASS-C (Positive Appraisal Style scale - content)
timeFrame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum
measure: BRS (Brief Resilience Scale)
timeFrame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum
measure: BSS-RI (Birth Satisfaction Scale - Revised Indicator)
timeFrame: Collected only at second follow-up measurement 6 weeks postpartum
measure: PBQ (Postpartum Bonding Scale)
timeFrame: Collected only at second follow-up measurement 6 weeks postpartum
measure: mARM (mobile Agnew Relationship Measure)
timeFrame: Collected only at first follow-up measurement after 4 weeks of study
measure: uMARS (user version of the Mobile Application Rating Scale)
timeFrame: Collected only at first follow-up measurement after 4 weeks of study
measure: MFA (Maternal-Fetal Attachment Scale)
timeFrame: From baseline measurement until first follow-up measurement after 4 weeks of study
measure: GSE (General Self-Efficacy Scale)
timeFrame: From baseline measurement until the second follow-up measurement at 6 weeks postpartum
measure: Adherence
timeFrame: Collected passively during app use period (4 weeks)
Other outcomes:
measure: BFI-10 (Big Five Inventory-10)
timeFrame: Collected only during baseline measurement
measure: PMH (Positive Mental Health scale)
timeFrame: Collected only during baseline measurement
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
References: