Midwife-led Cognitive Behavioral Intervention for Perinatal Depression. Multisite RCT
Effectiveness of Midwife-led Cognitive Behavioral Intervention for Perinatal Depression in Ethiopia: A Multisite Randomized Controlled Trial.
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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Részletes leírás
The structured approach of Cognitive Behavioral Intervention (CBI) is beneficial in reducing Perinatal Depression (PND). It empowers women with practical skills to manage stress beyond the treatment period, foster resilience, and improve coping abilities. CBI increases assertiveness and strengthens relationships, which encourages women to seek support. Its behavioral activation component reduces social withdrawal through promoting engagement in supportive activities such as mother support groups and peer networks. Despite CBI yielding meaningful healthcare benefits and reducing PND, its applicability using non-mental healthcare professionals has not been tested in Ethiopia. Leveraging midwives to deliver CBI may be an alternative strategy to narrow the significant unmet need for mental health care. Moreover, midwives are uniquely positioned to deliver CBI interventions for PND due to their accessibility across the maternal health care continuum and their trusted relationships with mothers.
The intervention has a pre-specified session duration and frequency, which may ensure consistency, fidelity, and replicability across providers and settings. It is also expected to enhance adaptability for delivery by non-mental health care professionals, for low-resource settings, where access to specialized mental health services is limited.
Tanulmány típusa
Beiratkozás (Becsült)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi kapcsolat
- Név: Shimeles B. Zewude
- Telefonszám: +852-57795794
- E-mail: shimeles-biru.zewude@connect.polyu.hk
Tanulmányi helyek
-
-
South Gondar
-
Debre Tabor, South Gondar, Etiópia
- Addis Zemen Hospital
-
Debre Tabor, South Gondar, Etiópia
- Debre Tabor specialised hospital
-
Debre Tabor, South Gondar, Etiópia
- Wereta Hospital
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
Inclusion Criteria:
- 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.
Exclusion Criteria:
- EPDS score of ≥ 20.
- Women with active suicidal ideation.
- Participants with severe medical or obstetric conditions.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Egyetlen
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Midwife-led Cognitive Behavioral 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 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.
|
|
Nincs beavatkozás: Usual care
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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in perinatal depression
Időkeret: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
|
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).
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Perceived Problem-solving
Időkeret: At two time points: Baseline assessment (T0), and three month following the intervention.
|
The Negative Problem Orientation Questionnaire (NPOQ) is a 12-item instrument that assesses participants' cognitive set on their problem-solving abilities.
The participant rates each item using a 5-point Likert scale.
A higher score indicates doubt about the ability to cope and less cognitive set for challenging problems.
|
At two time points: Baseline assessment (T0), and three month following the intervention.
|
|
Change in perceived social supports
Időkeret: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
|
Perceived social support will be evaluated using the short form of the Social Support Questionnaire (SSQ).
Respondents rate the six-item SSQ using a 6-point Likert scale from 0 (not at all) to 5 (always).
|
Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
|
|
Change in Perceived Stress Levels
Időkeret: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
|
The Perceived Stress measurement includes10 items that evaluate participants' stress experiences over the past month.
Each item is rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often), and the total score ranges from 0 to 40, with higher scores indicating greater perceived stress.
|
Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
|
|
Change in cognitive conditions
Időkeret: Baseline outcome assessment (T0) and three months following the intervention (T2).
|
The Automatic Thoughts Questionnaire-8 (ATQ-8) is a psychological tool used to measure change in cognitive functioning following Cognitive Behavioral Intervention (CBI).
It contains 8 questions that check the frequency of negative thoughts that crossed participants' minds during the past week.
The scale is a 5-point Likert scale from not at all (1) to all the time (5), and as the score increases, the frequency of negative thought patterns increases.
|
Baseline outcome assessment (T0) and three months following the intervention (T2).
|
|
Change in behavioral activation status
Időkeret: Baseline assessment (T0) and three months following the intervention (T2).
|
Behavioral Activation for Depression Scale-Short Form (BADS-SF) will be used to measure behavioral change in activities.
The scale uses a 7-point Likert scale ranging from 0 (not at all) to 6 (completely).
A higher total score indicates greater behavioral activation.
|
Baseline assessment (T0) and three months following the intervention (T2).
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Becsült)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- HSEARS20260512003
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
IPD terv leírása
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .