Smartphone-based intervention for reducing postpartum depressive symptoms (Smart-e-Moms): Randomized controlled trial

Smartphone-based intervention for reducing postpartum depressive symptoms (Smart-e-Moms): Randomized controlled trial - Smart-e-Moms

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00032324

Enrollment

556

Registered

2024-01-26

Start date

2024-08-15

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum depressive symptoms F53.0

Interventions

Group 1: The intervention group receives a therapist-guided smartphone-based intervention consisting of 10 sessions that are delivered to the participants over the course of five weeks. Sessions last

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

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

Exclusion criteria: Acute psychotic symptoms or acute suicidality. Current Psychotherapy.

Design outcomes

Primary

Measure	Time frame
Postpartum depressive symptoms, measured by the Edinburgh Postpartum Depression Scale (EPDS), at 6 weeks, 12 weeks and 24 weeks after allocation	—

Secondary

Measure	Time frame
Secondary outcomes are: 1) Parental Bonding Questionnaire (PBQ-16, Reck et al., 2006) 2) General Self-Efficacy Scale (GSE, Jerusalem & Schwarzer, 1999) 3) 1-Item Perkhofer Stress Scale (Buchberger et al., 2019) 4) System Usability Scale (SUS, Brooke et al., 1996) 5) Client Satisfaction Questionnaire (CSQ-I, Boß et al., 2016) 6) An IBI-adapted version of the 12-item Working Alliance Inventory (WAI-SR, Berger, 2017) to assess the therapeutic alliance 7) Health care utilization will be asssesses with selected adapted items of the FIMPsy (Grupp, 2017) 8) Birth-related PTSD will be assessed with the City Birth Trauma Scale (City BiTS, Ayers, Wright & Thornton, 2018). 9) Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV, Schulte, 2006) 10) Childhood Trauma Screener (CTS, Grabe, 2012) 11) Sociodemographic, clinical and pregnancy-related variables will be assessed as potential moderators	—

Measure

Time frame

Secondary outcomes are: 1) Parental Bonding Questionnaire (PBQ-16, Reck et al., 2006) 2) General Self-Efficacy Scale (GSE, Jerusalem & Schwarzer, 1999) 3) 1-Item Perkhofer Stress Scale (Buchberger et al., 2019) 4) System Usability Scale (SUS, Brooke et al., 1996) 5) Client Satisfaction Questionnaire (CSQ-I, Boß et al., 2016) 6) An IBI-adapted version of the 12-item Working Alliance Inventory (WAI-SR, Berger, 2017) to assess the therapeutic alliance 7) Health care utilization will be asssesses with selected adapted items of the FIMPsy (Grupp, 2017) 8) Birth-related PTSD will be assessed with the City Birth Trauma Scale (City BiTS, Ayers, Wright & Thornton, 2018). 9) Patient Questionnaire on Therapy Expectation and Evaluation (PATHEV, Schulte, 2006) 10) Childhood Trauma Screener (CTS, Grabe, 2012) 11) Sociodemographic, clinical and pregnancy-related variables will be assessed as potential moderators

—

Countries

Germany

Contacts

Public ContactBabette Renneberg

Freie Universität Berlin

b.renneberg@fu-berlin.de+49 30 838 68975

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 27, 2026