| CTRI Number |
CTRI/2018/07/014836 [Registered on: 12/07/2018] Trial Registered Prospectively |
| Last Modified On: |
13/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effectiveness of psychological intervention by antenatal nurse for depression in pregnancy. |
|
Scientific Title of Study
|
A Multi-Centric Randomized Controlled Trial to Assess Effectiveness of the Brief Nursing Intervention for Depression in Pregnancy |
| Trial Acronym |
BIND-P Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramdas Ransing |
| Designation |
Assistant Professor (Psychiatry) |
| Affiliation |
BKL Walawalkar Rural Medical College |
| Address |
Department of Psychiatry
B.K.L.Walawalkar Rural Medical College,Sawarde, Tah: Chiplun, Dist: Ratnagiri
At Post : Nimgaon Mhalungi, Tah: Shirur, Dist : Pune-412209
Ratnagiri
MAHARASHTRA
415606
India |
| Phone |
09503145475 |
| Fax |
|
| Email |
ramdas_ransing123@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pracheth R |
| Designation |
Assistant Professor (Community Medicine) |
| Affiliation |
Yenepoya Medical College, Mangalore |
| Address |
Department of Community Medicine, Yenepoya Medical College ,Mangalore , Karnataka -575018
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09743289207 |
| Fax |
|
| Email |
prach1986@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prerna Kukreti |
| Designation |
Assistant Professor(Psychiatry) |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Department of Psychiatry, Lady Hardinge Medical College , Connaught Place, New Delhi: 110001
New Delhi
DELHI
110001
India |
| Phone |
09810612578 |
| Fax |
|
| Email |
dearfrien@gmail.com |
|
|
Source of Monetary or Material Support
|
| BKL Walawalkar Rural Medical College |
| Dharwad institute of Mental Health and Neurosciences (DIMHANS) |
| Indian Council of Medical Research |
| Lady Hardinge Medical College |
| Yenepoya Medical College |
|
|
Primary Sponsor
|
| Name |
Dr Ramdas Ransing |
| Address |
Department of Psychiatry, BKL Walawalkar Rural Medical college , Sawarde, Dist : Ratnagiri-415606 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Mahesh Mahadevaiah |
Department of Psychiatry, Dharwad institute of Mental Health and Neurosciences (DIMHANS) Belguam Road,Dharwad, Karnataka: 580008 |
| Dr Pracheth R |
Department of Community Medicine. Yenepoya Medical College , Mangalore , Karnataka -575018 |
| Dr Prerna Kukreti |
Department of Psychiatry, Lady Hardinge Medical College , Connaught Place, New Delhi: 110001 |
| Indian Council of Medical Research |
Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pracheth R |
Department of Community Medicine. Yenepoya Medical College |
Yenepoya Medical College , Mangalore , Karnataka -575018
Dakshina Kannada
KARNATAKA |
9743289207
prach1986@gmail.com |
| Dr Prerna Kukreti |
Department of Psychiatry, Lady Hardinge Medical College |
Lady Hardinge Medical College , Connaught Place, New Delhi: 110001
New Delhi
DELHI |
9810612578
dearfrien@gmail.com |
| Dr Ramdas Ransing |
Department of Psychiatry, BKL Walawalkar Rural Medical college |
At Post:Sawarde,Tah-Chiplun, Dist : Ratnagiri-415606
Ratnagiri
MAHARASHTRA |
9503145475
ramdas_ransing123@yahoo.co.in |
| Dr Mahesh Mahadevaiah |
Department of Psychiatry, Dharwad institute of Mental Health and Neurosciences (DIMHANS) |
Dharwad institute of Mental Health and Neurosciences (DIMHANS) Belguam Road,Dharwad, Karnataka: 580008
Dharwad
KARNATAKA |
7019061410
docmaheshm@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research, Lady Hardinge Medical College |
Approved |
| Institutional Ethical Review Board, Dharwad institute of Mental Health and Neurosciences (DIMHANS) |
Approved |
| Institutional Ethics Committee, BKL Walawalkar Rural Medical college |
Approved |
| Yenepoya University Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Antenatal, Perinatal and Post Natal women |
| Patients |
Antenatal/Perinatal/Postnatal women with Depression, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brief Nursing Intervention Module |
Antenatal care trained nurse will administer the Brief Nursing Intervention Module to the patients enrolled in intervention arm. |
| Comparator Agent |
Treatment As Usual |
Treatment given by psychiatrist for depression in pregnancy as per standardized protocol uniform for all four centers. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1) Pregnant women with spontaneous conception attending the Obstetric and Gynecology (OBG) OPD of the selected Hospital for first trimester antenatal care (ANC) visit
2)Clients planning to follow up for ANC care, delivery and postnatal follow up in the index Hospital.
2) Willing to give consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
1)History of intellectual disability,
2)Already on psychiatric treatment for any mental illness including depression. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PHQ-9 score depressive symptoms |
After three sessions of intervention delivered at gap of two weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications in pregnancy and during delivery |
9 months ANC and 4 weeks after delivery |
| Type and mode of delivery |
0-4 weeks after delivery |
| birth weight, neonatal complications, postnatal complications |
0-4 weeks after delivery |
| feeding practices, nutritional and immunization status of the infant |
0-6 months after delivery |
| Physical, Neuro-developmental growth of Infant, Mother-child interaction |
0-6 months after delivery |
|
|
Target Sample Size
|
Total Sample Size="776"
Sample Size from India="776"
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 Enrollment (India)
|
01/09/2018 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, open label,
parallel group, multi-center trial comparing the effectiveness of brief Nursing
intervention for depression in pregnancy. The study will be conducted at four
centers in India for 36 months. A total of 192 pregnant women (at each site) with
mild depression will be assessed for the effectiveness of the intervention. The
primary outcome measures will be PHQ-9 Score after three sessions of
intervention delivered at gap of two weeks. The secondary outcomes will be complications in pregnancy and during delivery, Type and mode of delivery,
birth weight, neonatal complications, postnatal complications, feeding
practices, nutritional status, immunization status and physical growth of
the infant. |