Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201901780867535 Date of Approval: 28/01/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Pilot evaluation of a telephone-based psychosocial intervention package for perinatal depression in Nigeria
Official scientific title Pilot evaluation of a telephone-based psychosocial intervention package for perinatal depression in Nigeria
Brief summary describing the background and objectives of the trial This study will adopt a mixed methods approach to pilot a telephone-based psychosocial intervention package for perinatal depression delivered by nurse/midwives in routine antenatal care. Perinatal depression (that is depressive symptoms occurring during pregnancy and those that continue during or begin in the first year postpartum) occur in between 10-30% of women presenting for antenatal care in Nigeria and is associated with poor outcomes for both the mother and her baby. Even though there is evidence to show that simple psychosocial interventions delivered by non-specialist health and community workers can alleviate the symptoms of perinatal depression and reduce the negative outcomes, majority of cases are not recognized by health care workers, who mostly also lack the skills to provide the needed interventions. Currently, there are no clear recommendations on the number of sessions needed for optimal effectiveness for psychosocial treatments, however, studies suggest that frequent contact or consistent attendance at sessions is vital in the recovery process. A major limitation noticed in earlier studies is the low rate of attendance at follow up counseling sessions attributed to logistic issues, financial constraints, other commitments including parenting older children, work and social responsibilities as well women’s perception that their problems had improved. Considering that current rate of mobile phone use in Nigeria is about 90%, an alternative to face-to-face counseling sessions for perinatal women is to deliver the interventions over the mobile telephone. The goal of this implementation research therefore is to adapt psychosocial interventions for perinatal depression for use over the mobile telephone and assess the acceptability, feasibility and the effectiveness of this approach. Qualitative methods, specifically key informant interviews will be used to explore the organizational structure of the maternal and child health facilities as well as barriers/facilitators for the successful implementation of mental health interventions. Following this, midwives in selected maternity hospitals within Ibadan will be trained to identify perinatal depression and deliver interventions based on treatment specifications of the World Health Organization Mental Health Gap Action Program Intervention Guide (mhGAP-IG). Interventions will be delivered fortnightly over the phone in one MCH clinic and in-person at the other clinic. Outcome measures including improvement in depressive symptoms, maternal well-being, parenting attitude and skills, infant growth and development as well as the acceptability of the modality for intervention will be compared between the two groups to explore the effectiveness of the telephone-based interventions.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Psychosocial
Anticipated trial start date 03/09/2018
Actual trial start date 17/09/2018
Anticipated date of last follow up 30/04/2020
Actual Last follow-up date 30/06/2020
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status 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 Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 WHO mhGAP interventions for perinatal depression delivered over the mobile telephone Fortnightly 4 initial sessions fortnightly. Addition 4- 8 sessions depending on patients score on the Edinburgh Postnatal Depression Scale (EPDS) Psychosocial interventions will include psychoeducation, addressing current psychosocial stressors and reactivating social networks. Elements of parenting skills including emphasize routine information provided to antenatal women (such as importance of routine antenatal visits, adequate nutrition and rest, preparation for delivery and signs that could indicate an emergency) as well as educating the women on newborn care, infant nutrition and responsive parenting. 75
Control Group WHO mhGAP interventions for perinatal depression delivered in face to face sessions in the clinic 20-30 minutes counseling session fortnightly 4 initial sessions fortnightly. Addition 4- 8 sessions depending on patients score on the Edinburgh Postnatal Depression Scale (EPDS) Psychosocial interventions will include psychoeducation, addressing current psychosocial stressors and reactivating social networks. Elements of parenting skills including emphasize routine information provided to antenatal women (such as importance of routine antenatal visits, adequate nutrition and rest, preparation for delivery and signs that could indicate an emergency) as well as educating the women on newborn care, infant nutrition and responsive parenting. 75 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women aged between 16 and 45 years Gestational are between 16 and 28 weeks EPDS score of 12 or more Meets criteria for DSM-IV depression on the brief Composite International Diagnostic Interview (CIDI) Provides informed consent Presence of other pregnancy related complications or immediate need for medical attention Presence of bipolar affective disorder or a psychotic disorder Will not be available for follow up Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 45 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 31/10/2017 University of Ibadan and University College Hospital Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Room 210, 2nd Floor Institute for Advanced Medical Research and Training Ibadan 200212 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recovery from depression at six months postpartum; defined as EPDS score less than 6. Six months after childbirth
Secondary Outcome Recruitment rates End point
Secondary Outcome Improvement in depression measured using the EPDS scores Baseline, monthly during intervention sessions and 6, 12, and 24 weeks postpartum
Secondary Outcome Disability measured on the WHO disability assessment schedule Baseline, 2 months after baseline and at 3 and 6 months postpartum
Secondary Outcome Birth outcomes At birth
Secondary Outcome Infant growth 3 and 6 months postpartum
Secondary Outcome Maternal attitudes Baseline, 2 months after baseline and at 3 and 6 months postpartum
Secondary Outcome Home environment 6 months postpartum
Secondary Outcome Cost of services Baseline, 2 months after baseline and at 3 and 6 months postpartum
Secondary Outcome Satisfaction with care 3 and 6 months postpartum
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Adeoyo Specialist Hospital Yemetu Ibadan 200211 Nigeria
Jericho Specialist Hospital Sabo-Onireke Road Ibadan 200272 Nigeria
Aremo General Hospital Aperin Ibadan 200211 Nigeria
Jericho Nursing Home Adekunle Fajuyi Road Ibadan 200272 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center National Institutes of Health 31 Center Drive Bethesda MD 20892 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Prof O Olaopa The Provost, College of Medicine, University of Ibadan, College Building, Queen Elizabeth II Road Ibadan 200212 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
Prof Oye Gureje Department of Psychiatry, College of Medicine, University of Ibadan, Queen Elizabeth II Road Ibadan 200212 Nigeria
Prof Ian Bennett Department of Family Medicine, 4225 Roosevelt Way NE, Ste 308 Seattle 98195 United States of America
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bibilola Oladeji bibideji@yahoo.com 2348023324989 Department of Psychiatry, Clinical Sciences Building, College of medicine, University of Ibadan, Queen Elizabeth II Road
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Adetoro Olorunfemi allstardollybabe@yahoo.com 2348022627031 Department of Psychiatry, College of Medicine, University of Ibadan, Queen Elizabeth II Road
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Project Supervisor
Role Name Email Phone Street address
Scientific Enquiries Bibilola Oladeji bibideji@yahoo.com 2348023324989 Department of Psychiatry, Clinical Sciences Building, College of Medicine, University of Ibadan, Queen Elizabeth II Road
City Postal code Country Position/Affiliation
Ibadan 200212 Nigeria Senior Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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