Depression, AnxietyIPMHNCT06456307
Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
A study testing Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry) in people with Depression, Anxiety and Antenatal Depression, run by Kenyatta National Hospital at 2 sites in Kenya.
Trial summary
Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Antenatal Depression, Postnatal Depression
- What is being tested?
- Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,970 participants
- Where
- 2 sitesKenya
- Study dates
- 17 Feb 2025to Mar 2028
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant and ≥28 weeks gestation
- Attending ANC care at the facility
- ≥14 years old
- Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3)
- Willing to return to the MCH and PMTCT clinic for study visits
Who cannot join
- Less than 28 weeks gestation
- Any woman at high risk of self-harm based on a study self-harm assessment protocol,
- Has cognitive impairments or psychotic symptoms
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya2 sites, 2 recruiting
- Recruiting
Kenyatta National Hospital
Nairobi
John Kinuthia, MBChB, MMed, MPH, +254722799052, kinuthia@uw.edu
John Kinuthia, MBChB, MMed, MPH
- Recruiting
HomaBay, Siaya and Kisumu
Western Kenya
John Kinuthia, MBChB, MMed, MPH, +254722799052, kinuthia@uw.edu
About this study
Perinatal mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.
Read the detailed description
Globally, perinatal mood and anxiety disorders (PMAD) impacts 10-20% of perinatal women, with a pooled prevalence of depression at 11.9% and anxiety at 15.2%. Most of these cases go undetected and untreated since worldwide under 30% of those requiring mental health services have access to them. The Kenya Mental Health Action Plan 2021-2025 highlights a goal of expanding access to mental health services including in Maternal and Child Health clinics. In Kenya, over 95% of all pregnant women receive at least one antenatal care service from a skilled provider. However, mental health screening is not currently standardized in antenatal and postnatal care visits in Kenya, representing a missed opportunity to offer mental health services to those with PMAD symptoms.
Several evidence-based interventions are recommended by the WHO for identification and management of PMAD by non-specialist providers in resource-limited settings. However, their implementation in routine care in Kenya is currently limited, due to lack of provider training and comfort with perinatal mental health treatments and poor linkage across cadres of providers (such as primary care providers and mental health providers). Sustainable integration of perinatal mental healthcare in Kenya's routine perinatal services requires development and testing of tailored interventions that strengthen workforce capacity and facilitate linkage across provider cadres, as well as implementation strategies to facilitate high-quality intervention delivery. The investigators have identified three EBIs to promote perinatal mental health: universal WHO Mental Health Gap Action Programme (mhGAP)-recommended mental health screening, the Problem Management Plus (PM+) counseling intervention for women experiencing PMAD, and telepsychiatry for women with severe symptoms, suicidality or no response to PM+. The investigators propose to combine these interventions in a stepped care model, named the Integrated Perinatal Mental Health program (IPMH), and develop implementation strategies to support the model's integration into routine perinatal care in Kenya. The investigators will then evaluate IPMH's effectiveness and implementation outcomes in a Hybrid Type II trial. The study will be conducted in clinics in Kisumu, Siaya, and Homa Bay counties of Western Kenya, Kenya.
Broad objective: This study seeks to evaluate the effectiveness and implementation outcomes of Integrated Perinatal Mental Health Program (IPMH) that consists of universal mental health screening, problem management plus counseling intervention and telepsychiatry in a Hybrid Type II trial.
Aim 1: Using participatory design, optimize and adapt IPMH and develop implementation strategies.
Aim 2: Determine the effect of IPMH and implementation strategies on mental health, HIV care, and pregnancy outcomes among perinatal women from pregnancy to 6 months postpartum.
Aim 3: Determine effect of IPMH and its implementation strategies on service delivery and implementation outcomes, and identify multilevel drivers of successful implementation.
- Being tested
- Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)
- Keywords
- perinatal mood and anxiety disorders, telepsychiatry, Problem management plus, Integrated Perinatal Mental Health, Pregnancy, Postpartum, Depression, Anxiety
- Medical subject headings
- Depression, Anxiety Disorders, Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)Behavioural
The intervention includes systematic screening for PMAD symptoms using PHQ-2 and GAD-2, non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) and in-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to PM+
| Study group | Role | What they receive |
|---|---|---|
| Control arm: Enhanced Standard of care | No intervention | Control facilities will provide enhanced standard of care. The enhanced standard of care will include two enhancements: 1. HIV Testing Services (HTS) providers and lay workers will conduct screening for perinatal mood and anxiety disorders (PMAD) using the PHQ-2 and GAD-2. 2. The study team will provide a PMAD referral information sheet to all control facilities describing inpatient and outpatient psychiatry services at the nearby referral hospitals |
| Intervention arm: Integrated Perinatal Mental Health Program (IPMH) | Experimental | Intervention facilities will receive the Integrated Perinatal Mental Health Program (IPMH). This includes:
1. Systematic screening for PMAD symptoms using PHQ-2 and GAD-2. Positive screeners (PHQ-2≥3 and/or GAD-2≥3) will then be referred to nurses to administer additional screening by PHQ-9 and GAD-7
2. Non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) delivered weekly
3. In-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to Problem Management+ Receives: Behavioral: Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Patient Health Questionnaire-9 (PHQ-9). Score range 0-27. Higher score indicates more severe depression symptoms; score ≥10 indicates symptoms of moderate-to-severe depression
Measured: 6-months postpartum
Anxiety
Generalised Anxiety Disorder-7 item (GAD-7). Score range 0-21. Higher score indicates more severe anxiety symptoms; score ≥10 indicates symptoms of moderate-to-severe anxiety
Measured: 6-months postpartum
Secondary outcomes (3)
Quality of life
World Health Organisation Quality-of-Life Brief Version (WHOQOL-BREF) score. Score range 0 - 100. Higher scores indicate higher quality of life.
Measured: 6-months postpartum
Adverse pregnancy outcomes
Any adverse pregnancy outcomes defined as the following: Pregnancy loss, stillbirth, pre-term birth, low birth weight, intrauterine growth restriction, neonatal hospital admission and neonatal death
Measured: 6-weeks postpartum
Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)
Reducing Tension Checklist. Score range 0 - 40. Higher score indicates more use of behavioral and psychosocial coping skills.
Measured: 6-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start17 Feb 2025
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depression, AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 1:1 cluster-randomized trial will be conducted in 20 facilities in Western Kenya among pregnant women (3rd trimester) with perinatal mood and anxiety (PMAD) symptoms (Patient Health Questionnaire-2 \[PHQ-2\]≥3 or Generalized Anxiety Disorder-7 \[GAD-7\]≥3). Control facilities will provide enhanced standard of care (PMAD screening followed by standard of care). Intervention facilities will provide IPMH. Effectiveness outcomes will be compared between study arms.
- Masking
- None (open label)
- Enrolment
- 2,970 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenyatta National Hospital
- Sponsor type
- Other government
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- John Kinuthia, MBChB, MMed, MPH, Principal investigator, Kenyatta National HospitalKeshet Ronen, MPH, PhD, Principal investigator, University of WashingtonAmritha Bhat, MBBS, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06456307
- Sponsor's protocol ID
- P425/04/2023
- Other IDs
- STUDY00017933, R01MH133266
- Acronym
- IPMH
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2024
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from IPMH will be available through the NMIH Data Archive
Publications
Karume AK, Ngumbau N, Ongeri L, Neema A, Kaggiah A, Owaga D, Maina C, Ndambuki C, Wang Y, Pothan L, Rose A, Larsen A, Masyuko S, Richardson BA, Wagner AD, Bhat A, Ronen K, Kinuthia J. Integration of stepped care for perinatal mood and anxiety disorders among women attending maternal and child health clinics in Kenya: Protocol for a cluster randomized controlled trial. PLoS One. 2026 Jun 11;21(6):e0349732. doi: 10.1371/journal.pone.0349732. eCollection 2026.
PubMed 42275413Karume AK, Ngumbau N, Ongeri L, Neema A, Kaggiah A, Owaga D, Maina C, Ndambuki C, Wang Y, Pothan L, Rose A, Larsen A, Masyuko S, Richardson BA, Wagner AD, Bhat A, Ronen K, Kinuthia J. Integration of stepped care for perinatal mood and anxiety disorders among women attending maternal and child health clinics in Kenya: Protocol for a cluster randomized controlled trial. medRxiv [Preprint]. 2026 May 8:2026.05.06.26352574. doi: 10.64898/2026.05.06.26352574.
PubMed 42145615
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Stepped Care for Perinatal Mood and Anxiety Disorders Among Women Attending MCH Clinics
- ClinicalTrials.gov ID
- NCT06456307
- Acronym / sponsor ID
- IPMH / P425/04/2023
- Keywords
- perinatal mood and anxiety disorders, telepsychiatry, Problem management plus, Integrated Perinatal Mental Health, Pregnancy, Postpartum, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,970 participants (estimated)
- Lead sponsor
- Kenyatta National HospitalOther government
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Feb 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 13 Jun 2024 (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 mood and anxiety disorders (PMAD), defined as depression and anxiety during pregnancy or up to 1 year postpartum, account for substantial morbidity and mortality among birthing people globally especially in low- and middle-income countries. Several evidence-based interventions are recommended for identification and management of PMAD by non-specialist providers in resource-limited settings. This cluster-randomized trial seeks to evaluate the effect of a stepped-care intervention for screening and treatment of PMAD among perinatal women, on clinical and implementation outcomes.
Detailed description
Globally, perinatal mood and anxiety disorders (PMAD) impacts 10-20% of perinatal women, with a pooled prevalence of depression at 11.9% and anxiety at 15.2%. Most of these cases go undetected and untreated since worldwide under 30% of those requiring mental health services have access to them. The Kenya Mental Health Action Plan 2021-2025 highlights a goal of expanding access to mental health services including in Maternal and Child Health clinics. In Kenya, over 95% of all pregnant women receive at least one antenatal care service from a skilled provider. However, mental health screening is not currently standardized in antenatal and postnatal care visits in Kenya, representing a missed opportunity to offer mental health services to those with PMAD symptoms.
Several evidence-based interventions are recommended by the WHO for identification and management of PMAD by non-specialist providers in resource-limited settings. However, their implementation in routine care in Kenya is currently limited, due to lack of provider training and comfort with perinatal mental health treatments and poor linkage across cadres of providers (such as primary care providers and mental health providers). Sustainable integration of perinatal mental healthcare in Kenya's routine perinatal services requires development and testing of tailored interventions that strengthen workforce capacity and facilitate linkage across provider cadres, as well as implementation strategies to facilitate high-quality intervention delivery. The investigators have identified three EBIs to promote perinatal mental health: universal WHO Mental Health Gap Action Programme (mhGAP)-recommended mental health screening, the Problem Management Plus (PM+) counseling intervention for women experiencing PMAD, and telepsychiatry for women with severe symptoms, suicidality or no response to PM+. The investigators propose to combine these interventions in a stepped care model, named the Integrated Perinatal Mental Health program (IPMH), and develop implementation strategies to support the model's integration into routine perinatal care in Kenya. The investigators will then evaluate IPMH's effectiveness and implementation outcomes in a Hybrid Type II trial. The study will be conducted in clinics in Kisumu, Siaya, and Homa Bay counties of Western Kenya, Kenya.
Broad objective: This study seeks to evaluate the effectiveness and implementation outcomes of Integrated Perinatal Mental Health Program (IPMH) that consists of universal mental health screening, problem management plus counseling intervention and telepsychiatry in a Hybrid Type II trial.
Aim 1: Using participatory design, optimize and adapt IPMH and develop implementation strategies.
Aim 2: Determine the effect of IPMH and implementation strategies on mental health, HIV care, and pregnancy outcomes among perinatal women from pregnancy to 6 months postpartum.
Aim 3: Determine effect of IPMH and its implementation strategies on service delivery and implementation outcomes, and identify multilevel drivers of successful implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A 1:1 cluster-randomized trial will be conducted in 20 facilities in Western Kenya among pregnant women (3rd trimester) with perinatal mood and anxiety (PMAD) symptoms (Patient Health Questionnaire-2 [PHQ-2]≥3 or Generalized Anxiety Disorder-7 [GAD-7]≥3). Control facilities will provide enhanced standard of care (PMAD screening followed by standard of care). Intervention facilities will provide IPMH. Effectiveness outcomes will be compared between study arms.
| Arm | Type | Receives |
|---|---|---|
| Control arm: Enhanced Standard of care | No intervention | –Control facilities will provide enhanced standard of care. The enhanced standard of care will include two enhancements: 1. HIV Testing Services (HTS) providers and lay workers will conduct screening for perinatal mood and anxiety disorders (PMAD) using the PHQ-2 and GAD-2. 2. The study team will provide a PMAD referral information sheet to all control facilities describing inpatient and outpatient psychiatry services at the nearby referral hospitals |
| Intervention arm: Integrated Perinatal Mental Health Program (IPMH) | Experimental | Behavioral: Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)Intervention facilities will receive the Integrated Perinatal Mental Health Program (IPMH). This includes: 1. Systematic screening for PMAD symptoms using PHQ-2 and GAD-2. Positive screeners (PHQ-2≥3 and/or GAD-2≥3) will then be referred to nurses to administer additional screening by PHQ-9 and GAD-7 2. Non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) delivered weekly 3. In-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to Problem Management+ |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant and ≥28 weeks gestation
- Attending ANC care at the facility
- ≥14 years old
- Screen positive for PMAD symptoms (PHQ-2≥3 and/or GAD-2≥3)
- Willing to return to the MCH and PMTCT clinic for study visits
Key exclusion criteria (3 listed)
- Less than 28 weeks gestation
- Any woman at high risk of self-harm based on a study self-harm assessment protocol,
- Has cognitive impairments or psychotic symptoms
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 |
|---|---|---|
| Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry)The intervention includes systematic screening for PMAD symptoms using PHQ-2 and GAD-2, non-specialist delivery of PM+ for participants with likely depression (PHQ-9≥10) or anxiety (GAD-7≥10) and in-facility tele-linkage to mental health specialist for participants with severe depressive symptoms (PHQ-9≥15), those who endorse suicidality, or non-responders to PM+ | Behavioural | Intervention arm: Integrated Perinatal Mental Health Program (IPMH) |
Primary outcome
Depression
Time frame: 6-months postpartum
Patient Health Questionnaire-9 (PHQ-9). Score range 0-27. Higher score indicates more severe depression symptoms; score ≥10 indicates symptoms of moderate-to-severe depression
Anxiety
Time frame: 6-months postpartum
Generalised Anxiety Disorder-7 item (GAD-7). Score range 0-21. Higher score indicates more severe anxiety symptoms; score ≥10 indicates symptoms of moderate-to-severe anxiety
3 secondary outcomes
Quality of life
Time frame: 6-months postpartum
Adverse pregnancy outcomes
Time frame: 6-weeks postpartum
Mechanism of action for PM+ (use of behavioral and psychosocial coping skills)
Time frame: 6-weeks postpartum
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 10 Dec 2025.
- Derived from this study: PubMed 42275413Karume AK, Ngumbau N, Ongeri L, Neema A, Kaggiah A, Owaga D, Maina C, Ndambuki C, Wang Y, Pothan L, Rose A, Larsen A, Masyuko S, Richardson BA, Wagner AD, Bhat A, Ronen K, Kinuthia J. Integration of stepped care for perinatal mood and anxiety disorders among women attending maternal and child health clinics in Kenya: Protocol for a cluster randomized controlled trial. PLoS One. 2026 Jun 11;21(6):e0349732. doi: 10.1371/journal.pone.0349732. eCollection 2026.
- Derived from this study: PubMed 42145615Karume AK, Ngumbau N, Ongeri L, Neema A, Kaggiah A, Owaga D, Maina C, Ndambuki C, Wang Y, Pothan L, Rose A, Larsen A, Masyuko S, Richardson BA, Wagner AD, Bhat A, Ronen K, Kinuthia J. Integration of stepped care for perinatal mood and anxiety disorders among women attending maternal and child health clinics in Kenya: Protocol for a cluster randomized controlled trial. medRxiv [Preprint]. 2026 May 8:2026.05.06.26352574. doi: 10.64898/2026.05.06.26352574.
- Individual participant dataSharing planned: Yes. Data from IPMH will be available through the NMIH Data Archive
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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.
John Kinuthia, MBChB, MMed, MPH principal investigator
Kenyatta National Hospital
Keshet Ronen, MPH, PhD principal investigator
University of Washington
Amritha Bhat, MBBS, MD, MPH principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Perinatal Mental health program (systematic screening for PMAD, PM+ and tele-psychiatry) in people with Depression, Anxiety and Antenatal Depression, run by Kenyatta National Hospital at 2 sites in Kenya.
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 5 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: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. 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 Nancy Ngumbau, MBChB, MPH (+254713917226, nancym390@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: 6-months postpartum). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06456307, which also lists 2 linked publications.
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 10 Dec 2025.