Midwife-led Cognitive Behavioral Intervention for Perinatal Depression. Multisite RCT

Summary

Perinatal depression, or depression during pregnancy and within one year following childbirth, is the most burdensome maternal mental illness. Women in low-income countries like Ethiopia have suffered from the disease. PND carries several negative outcomes on women's mental health condition, their household functioning, workplace efficiency, and relationships with their children and families. It also has adverse outcomes on fetal and neonatal health, such as intrauterine fetal growth restriction, increased risk of underweight infants, and child cognitive and developmental delays.

Mothers experiencing PND in Ethiopia remain underserved because stakeholders' primary attention is directed toward other competing maternal concerns such as pregnancy-related hemorrhage or pregnancy-induced hypertension. As a result, depressed perinatal women continue to suffer without adequate recognition or intervention. Furthermore, women with PND in this country face numerous barriers to care; pharmacological treatment is limited due to affordability issues, a shortage of prescribing experts, and accessibility challenges. Thus, to challenge the treatment gap in maternal mental health care for PND, cognitive-behavioral interventions (CBI) may be an alternative that could be delivered by relatively accessible professionals such as midwives. Although midwives offer essential maternal healthcare services, the effectiveness of PND care using CBI stratagies delivered by them remains limited. This approach may help to ensure women with PND receive both maternal and mental healthcare holistically and sustainably.

This study aims to evaluate the effectiveness of midwife-led cognitive-behavioral intervention delivered to women with PND in reducing depression, increasing social support, lowering stress, and measuring progress in cognitive restructuring, behavioral activation, and perceived problem-solving compared to usual care.

The study will be conducted in three hospitals in the South Gondar region, Ethiopia. It will include pregnant women in the third trimester who are experiencing depression, able to hear and speak the local ( Amharic) language, and willing to be part of the study. Women with severe medical conditions that limit their ability to participate in the intervention will not be included.

Participants for the main RCT will be randomized into an intervention and control group in a 1:1 ratio. Participants enrolled in the intervention group will receive cognitive behavioral intervention delivered by trained midwives, and also receive usual maternal care services. The control group will receive usual standardized care. The intervention contains seven sessions that start at 32 weeks of pregnancy and continue after childbirth. The first five sessions will be provided during pregnancy and the remaining two sessions after childbirth. Both antepartum and postpartum sessions will be provided weekly in groups ( 8-10 participants per group), delivered in a face-to-face format, for 45 to 50 min.

The intervention strategies were formulated with the core principle of the cognitive behavioral model, and various strategies were used to contextualize it. The core content of each session was structured as a story-based example to capture and retain participants' attention and enhance clarity. Concepts were articulated using locally familiar and simple colloquial expressions. The behavioral activation techniques frequently practiced by Ethiopian women were incorporated to encourage engagement in routine activities. The intervention will utilize psychoeducation, group-based brainstorming, guided identification of negative thoughts, support to identify cognitive distortions, demonstrate technique to replace them with rational positive thoughts. For behavioral activation, activity scheduling and goal-setting techniques will be used to engage participants in pleasant activities. Additionally, problem-solving will be supported to improve social interaction and enhance parenting practices. Participants' take-home assignments and daily mood follow-up chart will also be used as part of the intervention strategies.

To evaluate the study effect, various outcome measurements will be conducted before the intervention, immediately after the intervention, and three months after the intervention.

Conditions

• Perinatal Depression
• Social Support
• Perceived Stress

Interventions

OTHER

Midwife-led Cognitive Behaviroal Intervention

The intervention contains seven sessions. The first session equips participants with foundational knowledge to recognize the cognitive, emotional, and behavioral symptoms of PND. The second session provides practical guidance to help participants identify and record negative thoughts. The third session demonstrates the technique of replacing negative thoughts with realistic thoughts. Session four involves engagement in a pleasant activity utilizing goal-setting strategies. Session five focuses on challenging parenting problems. Session six demonstrates techniques for identifying and acquiring social support. The final seventh session focuses on relapse prevention and maintaining gains.

Sponsors & Collaborators

• The Hong Kong Polytechnic University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2027-04-17

Completion

2027-05-17

Countries

• Ethiopia

Study Locations