Smartphone-based intervention for postpartum depressive symptoms (Smart-e-Moms): study protocol for a randomized controlled trial

TY - JOUR

T1 - Smartphone-based intervention for postpartum depressive symptoms (Smart-e-Moms): study protocol for a randomized controlled trial

AU - Daehn, Daria

AU - Meyer, Caroline

AU - Loew, Viola

AU - Wabiszczewicz, Jessica

AU - Pohl, Steffi

AU - Böttche, Maria

AU - Pawils, Silke

AU - Renneberg, Babette

N1 - © 2024. The Author(s).

PY - 2024/7/10

Y1 - 2024/7/10

N2 - BACKGROUND: Postpartum depression constitutes a significant public health issue, with prevalence rates ranging between 8 and 19% in high-income nations. Nevertheless, numerous barriers, including time constraints, societal stigmatization, and feelings of shame, contribute to the limited utilization of healthcare services during the postpartum period. Digital interventions offer an opportunity to enhance care for women experiencing postpartum depressive symptoms.METHODS: We will conduct a two-arm randomized controlled trial to assess the effectiveness of a smartphone-based intervention in comparison to a treatment-as-usual control group in Germany. Our aim is to randomize 556 participants in a 1:1 ratio. Participants in the intervention group will be provided access to a preventive smartphone-based intervention called "Smart-e-Moms," which incorporates therapeutic support and comprises 10 concise modules rooted in cognitive-behavioral therapy. For the intervention group, evaluations will take place at baseline (t0), prior to sessions 4 and 8 (intermediate assessments), and upon completing the intervention 6 weeks after baseline (t1). The control group's assessments will be at baseline (t0) and 6 weeks after baseline. Follow-up assessments are scheduled at 12 and 24 weeks from baseline to examine the short-term stability of any observed effects. We anticipate that participants in the intervention group will exhibit improvements in their postpartum depressive symptoms (as measured with the Edinburgh Postnatal Depression Scale). Additionally, we will analyze secondary outcomes, including maternal bonding, stress levels, self-efficacy, satisfaction with the intervention, and healthcare utilization.DISCUSSION: If Smart-e-Moms proves to be effective, it has the potential to play a significant role in postpartum depression care within German-speaking regions. Ideally, this intervention could not only benefit maternal well-being but also improve the prospects for healthy child development.TRIAL REGISTRATION: German clinical trials registry DRKS00032324. Registered on January 26, 2024.

AB - BACKGROUND: Postpartum depression constitutes a significant public health issue, with prevalence rates ranging between 8 and 19% in high-income nations. Nevertheless, numerous barriers, including time constraints, societal stigmatization, and feelings of shame, contribute to the limited utilization of healthcare services during the postpartum period. Digital interventions offer an opportunity to enhance care for women experiencing postpartum depressive symptoms.METHODS: We will conduct a two-arm randomized controlled trial to assess the effectiveness of a smartphone-based intervention in comparison to a treatment-as-usual control group in Germany. Our aim is to randomize 556 participants in a 1:1 ratio. Participants in the intervention group will be provided access to a preventive smartphone-based intervention called "Smart-e-Moms," which incorporates therapeutic support and comprises 10 concise modules rooted in cognitive-behavioral therapy. For the intervention group, evaluations will take place at baseline (t0), prior to sessions 4 and 8 (intermediate assessments), and upon completing the intervention 6 weeks after baseline (t1). The control group's assessments will be at baseline (t0) and 6 weeks after baseline. Follow-up assessments are scheduled at 12 and 24 weeks from baseline to examine the short-term stability of any observed effects. We anticipate that participants in the intervention group will exhibit improvements in their postpartum depressive symptoms (as measured with the Edinburgh Postnatal Depression Scale). Additionally, we will analyze secondary outcomes, including maternal bonding, stress levels, self-efficacy, satisfaction with the intervention, and healthcare utilization.DISCUSSION: If Smart-e-Moms proves to be effective, it has the potential to play a significant role in postpartum depression care within German-speaking regions. Ideally, this intervention could not only benefit maternal well-being but also improve the prospects for healthy child development.TRIAL REGISTRATION: German clinical trials registry DRKS00032324. Registered on January 26, 2024.

KW - Humans

KW - Depression, Postpartum/therapy

KW - Female

KW - Smartphone

KW - Randomized Controlled Trials as Topic

KW - Cognitive Behavioral Therapy/methods

KW - Germany

KW - Treatment Outcome

KW - Adult

KW - Mobile Applications

KW - Time Factors

KW - Telemedicine

U2 - 10.1186/s13063-024-08304-5

DO - 10.1186/s13063-024-08304-5

M3 - SCORING: Journal article

C2 - 38987846

VL - 25

SP - 469

JO - TRIALS

JF - TRIALS

SN - 1745-6215

IS - 1

ER -