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Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce
Eli Iacob1, Ryoko Kausler2, Marcia Williams3
1College of Nursing, University of Utah, Salt Lake City, UT, USA.
Insights
This study proposes a standardized telehealth protocol to reduce perinatal depression and anxiety (PDA). The randomized controlled trial (RCT) uses a group videoconference intervention (VCI) to improve maternal mental health outcomes.
Area of Science:
- Perinatal mental health
- Telehealth interventions
- Clinical trial methodology
Background:
- Perinatal depression and anxiety (PDA) affect 20% of individuals, leading to adverse outcomes for mother and child.
- Telehealth can mitigate access barriers to essential mental health services.
- Standardized study protocols are lacking, hindering comparisons of telehealth's effectiveness in reducing PDA.
Purpose of the Study:
- To provide a conceptual framework and a randomized controlled trial (RCT) protocol.
- To standardize research on telehealth interventions for perinatal mental health.
- To facilitate comparison of findings across diverse studies and settings.
Main Methods:
- A randomized controlled trial (RCT) evaluating a group videoconference intervention (VCI) for PDA.
- Participants assigned to VCI plus standard care or attention control (AC) plus standard care.
- Weekly 9-week sessions; VCI uses manualized MBCT, AC uses childbirth education.
Main Results:
- Primary outcomes: depressive symptoms (EPDS) and anxiety symptoms (GAD-7).
- The protocol aims to measure the effectiveness of VCI in reducing PDA symptoms.
- Data collection and analysis will determine the intervention's impact.
Conclusions:
- The RCT protocol offers a standardized approach for telehealth research in perinatal mental health.
- Applicable across various settings (rural/urban) and adaptable to diverse communities.
- Enhances comparability of findings and promotes evidence-based telehealth implementation.
Background:
Perinatal depression and anxiety (PDA) affect approximately 20 % of individuals and are associated with adverse outcomes, including preterm birth, low birth weight, and impaired cognitive development of the child. Telehealth may reduce access barriers to needed mental health services. However, lack of disseminated, standardized study protocols aimed at investigating the role of telehealth in reducing PDA symptoms limits the ability to compare findings across studies. The purpose of this paper is to provide a conceptual framework and a randomized controlled trial protocol (RCT) for use in future studies.
Methods And Analysis:
An RCT was designed to evaluate the effectiveness of a group videoconference intervention (VCI) to reduce PDA symptoms across pregnancy and postpartum period. Participants are randomly assigned to study groups: VCI + standard of care, or attention control (AC) + standard of care. Both groups have weekly one-hour group videoconference sessions for 9 weeks. The VCI groups are facilitated by a mental health professional using a manualized program based on mindfulness-based practices and cognitive behavioral therapy (MBCT). The AC groups are facilitated by a registered nurse using a manualized program for childbirth and parenting education. The primary outcomes are depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7).
Conclusion:
This RCT study protocol can be used as a standard approach to improve the ability to compare findings across studies, applied in any setting (e.g., rural or urban), and adapted to diverse communities.
Trial Registration:
ClinicalTrials.govNCT03932760.
