Maternal and child health

In perinatal women attending maternal and child health clinics in an LMIC setting, is there a difference in depressive and anxiety symptom scores between those receiving a brief psychological intervention delivered digitally versus in-person, during a period of pandemic-like service disruption?

The gap

While abstracts [6] and [8] compare digital and in-person delivery during the pandemic, they are set in high-income contexts (Spain, unspecified high-income), and abstract [7] focuses on LMICs but lacks a comparative digital vs. in-person design, leaving the specific question of comparative efficacy in LMICs unresolved.

Study design

Two-arm, parallel-group, individually randomized controlled trial with block randomization stratified by clinic

High-level approach

Continuous symptom outcomes (EPDS, GAD-7 mean change) are compared between arms using linear mixed-effects regression with a random intercept for clinic; session attendance as a count is analyzed via negative-binomial regression, and ordinal acceptability ratings via Mann-Whitney U tests.

Methodology

Design justification

Individual randomization within clinics, combined with a mixed-effects model accounting for clinic-level clustering, provides an unbiased comparison of digital versus in-person intervention efficacy while preserving real-world delivery heterogeneity [[5], [6]]. Conducting the trial during pandemic-like service disruption ensures the comparison reflects the constraints under which digital delivery would actually be deployed [[5], [7]].

Population

Perinatal women (≥18 years, ≤28 weeks gestation or ≤6 months postpartum) attending maternal and child health (MCH) clinics who screen positive for depressive and/or anxiety symptoms (e.g., EPDS ≥10 and/or GAD-7 ≥8) [[6]].

Setting

A cluster of 4–6 MCH clinics in a single peri-urban district in Kenya (or comparable LMIC setting), selected to reflect the stepped-care integration model described in [[6]], with existing mobile network coverage sufficient for digital delivery [[1]].

Sampling

Convenience sampling of eligible clinics from the district health authority's facilities; within participating clinics, consecutive sampling of all eligible perinatal women screening positive during the recruitment period, with simple random assignment (1:1) to digital or in-person intervention arms using computer-generated block randomization stratified by clinic [[5], [6]].

Sample-size approach

Superiority RCT comparing two means. Assuming a minimal clinically important difference of 3 points on the EPDS (SD ~5, based on perinatal depression intervention trials in LMIC settings), α=0.05, power=0.80: n per group = 2 × [(1.96 + 0.84)² × 5²] / 3² ≈ 44 per group. Adjusting for 20% attrition and an intra-class correlation (ICC) of 0.02 for clinic-level clustering with an average cluster size of 15: design effect = 1 + (15−1)×0.02 = 1.28. Final n = 44 × 1.28 × 1.20 ≈ 68 per group, total N ≈ 136. Rounded to 140 (70 per arm).

Variables

Independent variable: delivery modality (digital vs. in-person), randomized. Primary outcomes: change in EPDS score (depressive symptoms) ^[6] and change in GAD-7 score (anxiety symptoms) from baseline to 12-week post-intervention follow-up. Secondary outcomes: treatment adherence (sessions completed) ^[4], participant-reported acceptability (Likert scale), and retention rate. Covariates: age, parity, gestational age at enrollment, education level, baseline symptom severity, prior mental health history, household income, mobile phone ownership/digital literacy, and social support [[4], [6]].

Data sources

Baseline and follow-up EPDS and GAD-7 assessments administered by trained research assistants blind to allocation [[5], [6]]; session attendance logs maintained by intervention facilitators; participant acceptability questionnaire administered at end of treatment; demographic and clinical data extracted from MCH clinic records [[6]].

Time

18–24 months: 3 months for ethics approval and adaptation of intervention materials, 3 months for facilitator training and pilot testing, 12 months for recruitment and intervention delivery, 3 months for follow-up data collection and analysis.

Cost

Moderate: intervention adaptation and digital platform setup (~$8,000–12,000), facilitator training and supervision (~$5,000), research assistant stipends (~$6,000), participant compensation/transport reimbursement (~$3,000), data management and analysis (~$2,000). Total approximately $24,000–28,000, feasible with a career-development or medium research grant.

Ethics

Requires full IRB approval from the host country national ethics review board and affiliated institutional ethics committee. Written informed consent in local language. Risk: participants screening positive for severe depression or suicidal ideation (EPDS item 10 >0 or total >19) must be referred immediately to specialist mental health services and excluded from the trial. Data privacy protocols required for digital arm. Trial registration (e.g., PACTR or ClinicalTrials.gov) before enrollment.

Grounding references

Mobile Health for Perinatal Depression and Anxiety: Scoping Review — Hussain‐Shamsy N, Shah A, Vigod SN, Zaheer J, Seto E · Journal of Medical Internet Research, 2020 · DOI 10.2196/17011
A Preventive Social Media Intervention for Perinatal Depression and Anxiety in Regional, Rural, and Remote Communities: Participatory Co-Design Study. — Lynch KJ, Shatte ABR, Muller J, George K, Rossini G, Anson A · Journal of medical Internet research, 2026 · DOI 10.2196/91778
A Brief Intervention for the Treatment of Anxiety in Pregnancy: A Pilot Randomized Controlled Trial (The TAP Study). — Grigoriadis S, Sharma N, Dennis CL, Vigod SN, Rector N, Richter P · Psychotherapy and psychosomatics, 2026 · DOI 10.1159/000551731
Barriers to and Facilitators of User Engagement With Digital Mental Health Interventions: Systematic Review — Judith Borghouts, Elizabeth V. Eikey, Gloria Mark, Cinthia De Leon, Stephen M. Schueller, Margaret Schneider · Journal of Medical Internet Research, 2021 · DOI 10.2196/24387
Engagement, efficacy, and experiences of psychotherapy for perinatal populations with depression and anxiety during the COVID-19 pandemic. — Krohn HA, Shelly S, Gibori JE, Andrejek N, La Porte L, Lawson AS · Frontiers in psychiatry, 2025 · DOI 10.3389/fpsyt.2025.1686719
Integration of stepped care for perinatal mood and anxiety disorders among women attending maternal and child health clinics in Kenya: Protocol for a cluster randomized controlled trial. — Karume AK, Ngumbau N, Ongeri L, Neema A, Kaggiah A, Owaga D · PloS one, 2026 · DOI 10.1371/journal.pone.0349732
Internet-based interdisciplinary therapeutic group (Grupo Interdisciplinar Online, GIO) for perinatal anxiety and depression-a randomized pilot study during COVID-19. — Gomà M, Arias-Pujol E, Prims E, Ferrer J, Lara S, Glover V · Archives of women's mental health, 2024 · DOI 10.1007/s00737-023-01412-2

Full protocol

Detailed design

A two-arm, parallel-group, cluster-related superiority randomized controlled trial comparing a brief psychological intervention delivered digitally versus in-person among perinatal women screening positive for depressive and/or anxiety symptoms at MCH clinics. Within each participating clinic, eligible women are individually randomized 1:1 to the digital or in-person arm using computer-generated block randomization…

Free to read — the worked sample size, variable operationalisation, analysis plan, and literature-review starter, opened in the editor with free credits to use the writing tools.