Clinical Trial Details (PDF Generation Date :- Sat, 02 Oct 2021 19:04:33 GMT)

PDF of Trial CTRI Website URL - http://ctri.nic.in

CTRI Number CTRI/2019/02/017418 [Registered on: 04/02/2019] - Trial Registered Prospectively Last Modified On 01/02/2019 Post Graduate Thesis No Type of Trial Interventional Type of Study Preventive Behavioral Study Design Randomized, Parallel Group Trial Public Title of Study Education programme for mothers on depression after delivery Scientific Title of Psychosocial Education programme on postpartum depression, maternal stress and perceived Study maternal parenting self-efficacy among pregnant women in Udupi District, Karnataka - A Randomized Controlled Trial. Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Mrs Savitha Trial Coordinator (multi-center study) Designation Assistant Professor Affiliation Manipal College of Nursing Manipal Address Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal Manasa Settibettu house, Herga village, Parkala post, Udupi Taluk and District Udupi KARNATAKA 576104 India Phone 9481760372 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Mrs Savitha Query) Designation Assistant Professor Affiliation Manipal College of Nursing Manipal Address Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal Manasa Settibettu house, Herga village, Parkala post, Udupi Taluk and District Udupi KARNATAKA 576104 India Phone 9481760372 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Mrs Savitha Designation Assistant Professor Affiliation Manipal College of Nursing Manipal Address Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal Manasa Settibettu house, Herga village, Parkala post, Udupi Taluk and District Udupi

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KARNATAKA 576104 India Phone 9481760372 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > self Primary Sponsor Primary Sponsor Details Name Manipal college of nursing Manipal Address Manipal College of Nursing Manipal, Manipal Academy of Higher Education, Manipal Type of Sponsor Research institution Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Savitha Kasturba hospital, OBG OPD and wards of 9481760372 Manipal Kasturba medical 08202922572 college and hospital, savitha.umesh@manip Manipal Academy of al.edu Higher Education, Manipal Udupi KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Kasturba Medical Approved 21/11/2018 No College and Kasturba Hospital Institutional Ethics Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Other specified pregnancy relatedconditions Intervention / Type Name Details Comparator Agent Intervention psychosocial education Women attending antenatal programme clinic of Kasturba hospital will be recruited in the third trimester (26-30 weeks of gestation) of pregnancy. Women meeting the inclusion criteria and agree to take part in the study and sign the informed written consent will then be assessed through a screening by the researcher using Edinburg Postnatal Depression scale (EPDS). Women who score 9-13 in EPDS will be

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identified as at risk for developing postpartum depression and will be randomized with stratified block randomization to experimental and control group. Women who score above 13 in EPDS will be referred for psychiatric treatment. Women in the experimental group will be called in a separate room in the antenatal OPD when they come for antenatal checkup and will be provided Psychosocial Education programme individually. The control group will be provided with informational pamphlet and continue to receive standard care. They will be given the informational booklet after the study trial which may be useful for their subsequent pregnancies. Women in both the group will be screened periodically at 34 and 38th weeks of pregnancy with EPDS for assessing the worsening of symptoms of postnatal depression. Women will be then evaluated at three points of time in their postpartum period (i.e. on 3rd day in the postnatal ward, 6th week and 12th week of postnatal period in OBG OPD or in child immunization center). Women will be instructed to report to the investigator if they develop anxiety or depressive symptoms. Comparator Agent Informational pamphlet and The control group will be usual standard care provided with informational pamphlet and continue to receive standard care. They will be given the informational booklet after the study trial which may be useful for their subsequent pregnancies Inclusion Criteria Inclusion Criteria Age From 20.00 Year(s) Age To 40.00 Year(s) Gender Female Details 1.Pregnant women aged between 20-40 years
2.Those who are able to read and write English
or Kannada
3.Pregnant women who are planning to deliver
and come for follow-up and child
immunization after childbirth at Kasturba
Hospital, Manipal
4.Score inclusive of and between 9-13 on the
Edinburgs Postnatal Depression Scale during
pregnancy.
Exclusion Criteria Exclusion Criteria

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Details 1. Pregnant women with preexisting psychiatric diseases and on medication, bad obstetric history, pregnancy induced hypertension and or pre eclampsia. 2. Pregnant women aged above 40 years 3. Score less than 9 and above 13 on the Edinburgs Postnatal Depression Scale during pregnancy.

Method of Generating Stratified block randomization Random Sequence Method of Sequentially numbered, sealed, opaque envelopes Concealment Blinding/Masking Participant and Investigator Blinded Primary Outcome Outcome Timepoints reduction in depressive symptoms following 3 psychosocial education programme during postpartum period, at 1 week, 6 weeks and 12 weeks postnatal period. Secondary Outcome Outcome Timepoints Reduction in perceived maternal stress score 3 and improvement in perceived maternal parenting self efficacy score at 1 week, 6 weeks and 12 weeks postnatal period. Target Sample Size Total Sample Size=128 Sample Size from India=128 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial N/A Date of First 04/02/2019 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=4 Trial Months=11 Days=30 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details "none yet" Brief Summary This study is a Randomized controlled trial to evaluate the efficacy of Psychosocial education program on postnatal depression, maternal stress and perceived maternal parenting self efficacy, conducted at Kasturba Hospital, Manipal. The outcome measures will be Mean Edinburgs Postnatal Depression score, Mean Perceived Maternal Stress score and Mean Perceived Maternal Parenting Self efficacy score at 1 week, 6 weeks and 12 weeks of postnatal period.

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