Perinatal DepressionNCT07800299
Midwife-led Cognitive Behavioral Intervention for Perinatal Depression. Multisite RCT
A study testing Midwife-led Cognitive Behaviroal Intervention in people with Perinatal Depression and Social Support, run by The Hong Kong Polytechnic University at 3 sites in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Perinatal Depression, Social Support, Perceived Stress
- What is being tested?
- Midwife-led Cognitive Behaviroal Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 3 sitesEthiopia
- Study dates
- 15 Sep 2026to 17 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- EPDS score of ≥ 20.
- Women with active suicidal ideation.
- Participants with severe medical or obstetric conditions.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ethiopia3 sites
Addis Zemen Hospital
Debre Tabor, South Gondar
Debre Tabor specialised hospital
Debre Tabor, South Gondar
Wereta Hospital
Debre Tabor, South Gondar
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Perinatal Depression, Social Support, Perceived Stress
- Being tested
- Midwife-led Cognitive Behaviroal Intervention
- Keywords
- Perinatal Depression, Social Support, stress Level, Maternal Mental Health, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midwife-led Cognitive Behaviroal InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Midwife-led Cognitive Behavioral Intervention | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
Secondary outcomes (5)
Change in perceived social supports
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).
Measured: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
Change in Perceived Stress Levels
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.
Measured: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
Change in cognitive conditions
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.
Measured: Baseline outcome assessment (T0) and three months following the intervention (T2).
Change in behavioral activation status
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.
Measured: Baseline assessment (T0) and three months following the intervention (T2).
Change in Perceived Problem-solving
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.
Measured: At two time points: Baseline assessment (T0), and three month following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion17 Apr 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blinded, Multicenter Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngai Fei Wan, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07800299
- Sponsor's protocol ID
- HSEARS20260512003
- Status last verified
- Aug 2026
- First submitted
- 29 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To safeguard participants' confidentiality and protect privacy, I chose not to share participants' data.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Midwife-led Cognitive Behavioral Intervention for Perinatal Depression in Ethiopia: A Multisite Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07800299
- Acronym / sponsor ID
- HSEARS20260512003
- Conditions
- Perinatal Depression, Social Support, Perceived Stress
- Keywords
- Perinatal Depression, Social Support, stress Level, Maternal Mental Health, Ethiopia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 17 Apr 2027 (estimated)
- Study completion
- 17 May 2027 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single Blinded, Multicenter Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- EPDS score of ≥ 20.
- Women with active suicidal ideation.
- Participants with severe medical or obstetric conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Midwife-led Cognitive Behaviroal InterventionThe 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. | Other | Midwife-led Cognitive Behavioral Intervention |
Primary outcome
Change in perinatal depression
Time frame: 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.
5 secondary outcomes
Change in perceived social supports
Time frame: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
Change in Perceived Stress Levels
Time frame: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).
Change in cognitive conditions
Time frame: Baseline outcome assessment (T0) and three months following the intervention (T2).
Change in behavioral activation status
Time frame: Baseline assessment (T0) and three months following the intervention (T2).
Change in Perceived Problem-solving
Time frame: At two time points: Baseline assessment (T0), and three month following the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. To safeguard participants' confidentiality and protect privacy, I chose not to share participants' data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midwife-led Cognitive Behaviroal Intervention in people with Perinatal Depression and Social Support, run by The Hong Kong Polytechnic University at 3 sites in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shimeles B. Zewude (+852-57795794, shimeles-biru.zewude@connect.polyu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perinatal depression (time frame: Baseline (T0), Post-intervention (T1), and three months after completion of the intervention ( T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.