Powerly - Science-based Digital Intervention Preventing Postpartum Depression and Anxiety
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMarta Marciniak
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
being between 24 and 32 weeks pregnant,
owning an iPhone,
having sufficient fluency in German language
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Powerly
BehavioralPowerly 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Intervention - PowerlyExperimental treatment 1 intervention
Group B: Care as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
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
Time frame
From baseline measurement until the second follow-up measurement at 6 weeks postpartum2
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
Time frame
Collected only at second follow-up measurement 6 weeks postpartumSecondary outcomes
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
Time frame
From baseline measurement until the second follow-up measurement at 6 weeks postpartum2
PASS-C (Positive Appraisal Style scale - content)
comprises of 14 items and measures person's general style of evaluating stressors
Time frame
From baseline measurement until the second follow-up measurement at 6 weeks postpartum3
BRS (Brief Resilience Scale)
it measures resilience operationalized as an outcome of the process of adaptation to adversity, using 5 questions
Time frame
From baseline measurement until the second follow-up measurement at 6 weeks postpartum4
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
Time frame
Collected only at second follow-up measurement 6 weeks postpartumOther outcomes
1
BFI-10 (Big Five Inventory-10)
it assesses the five major dimensions of personality (openness, conscientiousness, extraversion, agreeableness, and neuroticism) with 10 items
Time frame
Collected only during baseline measurement2
PMH (Positive Mental Health scale)
includes nine items to measure specifically positive mental well-being
Time frame
Collected only during baseline measurementSponsors and contacts
Click on the lead sponsor to view all of their trials.
Marta Marciniak
Lead sponsor
Erasmus University Rotterdam
Sponsor institution
University of Zurich
Collaborator
Source ClinicalTrials.gov