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

Registry record from ClinicalTrials.gov (NCT07800299). This is a study registration, not published results. Lead sponsor: The Hong Kong Polytechnic University. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 192 participants (ESTIMATED). Conditions: Perinatal Depression, Social Support, Perceived Stress. Interventions: OTHER: Midwife-led Cognitive Behaviroal Intervention. Primary outcome measures: Change in perinatal depression , Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).. 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.