Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
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Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508760630809 Date of Registration: 12/08/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Feasibility, Acceptability and Effectiveness of Integrating Mental Health into Group ANC (M-GAIN) in Gombe- State Nigeria
Official scientific title Feasibility, Acceptability and Effectiveness of Integrating Mental Health into Group ANC (M-GAIN) in Gombe- State Nigeria
Brief summary describing the background and objectives of the trial Title: Feasibility, Acceptability, and Effectiveness of Integrating Mental Health into Group Antenatal Care (M-GAIN) in Gombe State, Nigeria Background: Maternal mental health is a critical yet often neglected component of antenatal care (ANC), particularly in low-resource settings like Nigeria. Perinatal mental disorders (PMDs), including depression and anxiety, affect 8–30% of pregnant women nationwide, with rates as high as 36% in Northern Nigeria due to socioeconomic stressors, early marriage, and limited healthcare access. Poor maternal mental health is linked to adverse outcomes, including low ANC attendance, preterm birth, and impaired infant development. Despite this, mental health services are rarely integrated into routine maternal care. The Group ANC (G-ANC) model, introduced in Gombe State with support from the Clinton Health Access Initiative (CHAI), has improved facility-based deliveries and ANC quality. However, mental health remains unaddressed in this model. The M-GAIN study seeks to integrate mental health promotion, prevention, and treatment into G-ANC, using a co-developed intervention package based on WHO guidelines. Objective: This study aims to assess the feasibility, acceptability, and preliminary effectiveness of integrating mental health into G-ANC (M-GAIN) in Gombe State. Key objectives include: 1.Evaluating the implementation feasibility of M-GAIN, including screening rates and healthcare worker adherence. 2.Assessing acceptability among pregnant women and primary healthcare workers (PHCWs). 3.Measuring effectiveness in reducing symptoms of depression and anxiety among participants.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MGAIN
Disease(s) or condition(s) being studied Mental and Behavioural Disorders,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial interventions for perinatal depression
Anticipated trial start date 18/08/2025
Actual trial start date
Anticipated date of last follow up 31/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 1260
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Integration of mental health promotion and prevention messaging into routine Group antenatal care Over 6 routine antenatal visits From booking for antenatal care to delivery- on the average 5-7 months The Group Antenatal Care (GANC) follows WHO recommendations for 8 antenatal visits. Women are assigned into groups at the registration/ booking visit while subsequent ANC meetings are for the GANC meetings (Meeting 1-7). Mental health messaging is included in meetings 1, 2, 3, 5, 6, 7. Meeting 1- Mental and emotional wellbeing in pregnancy- provides education about the importance of mental health in the perinatal period Meeting 2- Common perinatal mental disorders- signs and symptoms of depression, anxiety and psychosis and need to seek help for these problems Meeting 3- Causes of mental disorders and consequences of untreated mental health problems pregnancy Meeting 5- Building supportive relationships- focuses on the importance of social support to mental health and need/how to build a social network Meeting 6- Normal infant development, recognizing developmental delays/ disorders and nurturing and responsive parenting Meeting 7- Postpartum mental disorders- signs of postpartum mental disorder, consequences and importance of seeking help early Group problem solving at every visit using women's questions/ problems dropped into the 'I wonder basket' component of GANC 600
Experimental Group Psychosocial Interventions for common mental disorders 6-10 sessions delivered every two weeks over the perinatal period. Each session is expected to last 20-30 minutes. 4-10 months For women who meet diagnostic criteria for depression or anxiety. Manualised intervention sessions delivered by trained and supervised primary healthcare workers in the clinics assigned to intervention arm. The treatment sessions, including the following interventions- Psychoeducation (specific for diagnosis- depression or anxiety) Behavioral activation for women with depression Mindfulness/ relaxation interventions (breathing exercises, mindful walking) for women with anxiety Thinking Healthy- for all women Addressing current psychosocial problems- using a problem solving approach for all women Women with suicidal thoughts or severe depression must be reviewed by the doctor or the psychiatrist 60
Control Group Treatment as usual Routine GANC visits with referral for mental health interventions From booking to PNC visit 4 - 8 months In this arm, primary healthcare workers are not trained to deliver specific mental health interventions. However, the GANC has a group problem solving component 'I wonder basket'. Women are encouraged to drop their questions of current stressors into the basket anonymously and all women brain storm together to suggest solutions. Usual care makes room for referral of women identified to have mental disorders to the Psychiatry Unit of the State General Hospital or to the Federal Medical Centre Gombe 600 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Consenting women registering for ANC in the selected clinics 2. Gestational age between 18 and 28 weeks 3. Pregnant women greater than 16 years of age 1. Non-consenting women 2. GA above 28 weeks 3. Women with a medical emergency 4. Women with a past history of schizophrenia or bipolar affective disorder Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 16 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 19/05/2025 Gombe State Ministry of Health Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
State Secretariat, Gombe, Gombe State Gombe PMN 42 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean EPDS score compared between intervention and control arm Baseline, 2 months after baseline, 3 months postpartum
Primary Outcome Remission of depression symptoms defined as EPDS less than 6 Baseline, 2 months after baseline, 3 months postpartum
Secondary Outcome Functional impairment measured using scores on the WHO disability assessment schedule WHODAS Baseline, 2 months after baseline and 3 months postpartum
Secondary Outcome Maternal attitudes measured on the Maternal Adjustment and Maternal Attitudes Scale MAMAs Baseline, 2 months after baseline and 3 months postpartum
Primary Outcome Mean GAD-7 scores Baseline, 2 months after baseline and 3 months postpartum
Secondary Outcome Infant birth weight At birth
Secondary Outcome Mode of delivery At birth
Secondary Outcome Infant growth 3 months postpartum
Secondary Outcome Social support measured on the maternity social support scale Baseline, 2 months after baseline and 3 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gombe State Primary Healthcare Board Gombe Gombe Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Flourishing Minds LLC NA NA United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Clinton Health Access Initiative 7 Ganges St, Maitama Abuja 900271 Nigeria Non-governmental organization
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olufunke Fasawe ofasawe@clintonhealthaccess.org +2348026941088 7 Ganges St, Maitama
City Postal code Country Position/Affiliation
Abuja Nigeria PI
Role Name Email Phone Street address
Public Enquiries David Adeyemi dadeyemi@clintonhealthaccess.org +2348035654717 7 Ganges St, Maitama
City Postal code Country Position/Affiliation
Abuja Nigeria Co I
Role Name Email Phone Street address
Scientific Enquiries Bibilola Oladeji bibideji@yahoo.com +2348023324989 University of Ibadan
City Postal code Country Position/Affiliation
Ibadan Nigeria Co PI
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data can be made available after being de-identified following publication of the results of this trial. Analytic Code,Informed Consent Form,Study Protocol IPD will be available between 2 and 5 years following publication of the results of this trial Researchers who provide methodologically sound proposals should direct their requests to: The Country Director, Clinton Health Access Initiative Nigeria, 7 Ganges St, Maitama, Abuja. Access to the data can only be granted following a signed data use agreement.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Target no of participants 07/08/2025 There was an error in entering this information in the trial details section. 1200 1260