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

NCT07800299 | Not Yet Recruiting

• 1 other identifier: HSEARS20260512003
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 3

Brief Summary

Perinatal depression(PND), 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. Perinatal depression(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 the developing fetus and neonatal health, such as intrauterine 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 haemorrhage 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 play a critical role in maternal healthcare provision, the efficacy of supportive care for perinatal depression utilizing CBI techniques 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 zone, 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. Eligible participants 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 the standard usual 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 includes psychoeducation, group-based brainstorming, guided identification of negative thoughts, identification of cognitive distortions, and demonstration of techniques to replace negative with rational thoughts. For behavioral activation, activity scheduling and goal-setting techniques are incorporated to support engagement of 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 charts 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

Keywords

Perinatal Depression; Social Support; stress Level; Maternal Mental Health; Ethiopia

Outcome Measures

Primary Outcomes (1)

• Change in perinatal depression

  Perinatal depression (PND) is the primary outcome of the study, which is measured using the Edinburgh Postnatal Depression Scale (EPDS). Participants will rate their experiences using a 10-item EPDS tool, with each item scored on a 4-point Likert scale between 0 and 3. The total score ranges from 0 to 30, with higher scores indicating more depressive symptoms.

  Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).

Secondary Outcomes (5)

• Change in perceived social supports

  Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).

• Change in Perceived Stress Levels

  Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).

• Change in cognitive conditions

  Baseline outcome assessment (T0) and three months following the intervention (T2).

• Change in behavioral activation status

  Baseline assessment (T0) and three months following the intervention (T2).

• Change in Perceived Problem-solving

  At two time points: Baseline assessment (T0), and three month following the intervention.

Study Arms (2)

Midwife-led Cognitive Behavioral Intervention

EXPERIMENTAL

Other: Midwife-led Cognitive Behaviroal Intervention

Usual care

NO INTERVENTION

Participants will receive standard usual care. This standard usual care includes perinatal education on personal health, adequate sleep, counselling on healthy nutrition, self-care, and an obstetric complication readiness plan. Counselling on where and how to get support in case of an adverse event or emergency.

Interventions

Midwife-led Cognitive Behaviroal Intervention OTHER

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 techniques for 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.

Midwife-led Cognitive Behavioral Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 or more years.
• In the third trimester of pregnancy.
• Speak and read the local Amharic language.
• Women who screen positive for perinatal depression with an EPDS score ≥7.

You may not qualify if:

• EPDS score of ≥ 20.
• Women with active suicidal ideation.
• Participants with severe medical or obstetric conditions.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (3)

Addis Zemen Hospital

Debre Tabor, South Gondar, Ethiopia

Location

Debre Tabor specialised hospital

Debre Tabor, South Gondar, Ethiopia

Location

Wereta Hospital

Debre Tabor, South Gondar, Ethiopia

Location

Central Study Contacts

Shimeles B. Zewude

CONTACT

+852-57795794; shimeles-biru.zewude@connect.polyu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: Single Blinded, Multicenter Randomized Controlled Trial

Study Record Dates

• First Submitted: August 29, 2026
• First Posted: September 2, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): April 17, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ET (3)