Smartphone-based intervention for reducing postpartum depressive symptoms (Smart-e-Moms): Randomized controlled trial
Not Applicable
- Conditions
- Postpartum depressive symptomsF53.0Mild mental and behavioural disorders associated with the puerperium, not elsewhere classified
- Registration Number
- DRKS00032324
- Lead Sponsor
- Freie Universität Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 556
Inclusion Criteria
Women between 6 weeks and 6 months after delivery with an elevated score of postpartum depressive symptomatology (EPDS = 10, cutoff for clinically relevant depressive symptoms)
Exclusion Criteria
Acute psychotic symptoms or acute suicidality. Current Psychotherapy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postpartum depressive symptoms, measured by the Edinburgh Postpartum Depression Scale (EPDS), at 6 weeks, 12 weeks and 24 weeks after allocation
- Secondary Outcome Measures
Name Time Method Secondary outcomes are: <br>1) Parental Bonding Questionnaire (PBQ-16, Reck et al., 2006)<br>2) General Self-Efficacy Scale (GSE, Jerusalem & Schwarzer, 1999)<br>3) 1-Item Perkhofer Stress Scale (Buchberger et al., 2019)<br>4) System Usability Scale (SUS, Brooke et al., 1996)<br>5) Client Satisfaction Questionnaire (CSQ-I, Boß et al., 2016)<br>6) An IBI-adapted version of the 12-item Working Alliance Inventory (WAI-SR, Berger, 2017) to assess the therapeutic alliance<br>7) Health care utilization will be asssesses with selected adapted items of the FIMPsy (Grupp, 2017)<br>8) Birth-related PTSD will be assessed with the City Birth Trauma Scale (City BiTS, Ayers, Wright & Thornton, 2018). <br>9) Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV, Schulte, 2006) <br>10) Childhood Trauma Screener (CTS, Grabe, 2012) <br>11) Sociodemographic, clinical and pregnancy-related variables will be assessed as potential moderators