| CTRI Number |
CTRI/2025/04/085792 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Psychosocial intervention] |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Structured Family Psycho-education Programme for caregivers of women with postpartum psychosis |
|
Scientific Title of Study
|
Effectiveness of Structured Family Psycho-education Programme for caregivers of women with postpartum psychosis |
| Trial Acronym |
SFPP |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIMH/A&E-SA 3-380/Ph.D/PSW/RS/2021-23 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rupa Sanadi |
| Designation |
PhD scholar |
| Affiliation |
NIMHANS |
| Address |
Dr.M V Govindaswamy building Dept of PSW NIMHANS Bangalore
Dr. M V Govindaswamy building Dept of PSW NIMHANS Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
8762839086 |
| Fax |
|
| Email |
rupasanadi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr E Arvindraj |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Dr.M V Govindaswamy building Dept of PSW NIMHANS Bangalore,
Bangalore
KARNATAKA
560029
India |
| Phone |
918026995875 |
| Fax |
|
| Email |
aravind.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr E Arvindraj |
| Designation |
Additional Professor |
| Affiliation |
NIMHANS |
| Address |
Dr.M V Govindaswamy building Dept of PSW NIMHANS Bangalore,
Bangalore
KARNATAKA
560029
India |
| Phone |
918026995875 |
| Fax |
|
| Email |
aravind.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Research Council (MRC) – United Kingdom |
|
|
Primary Sponsor
|
| Name |
BCHADS Project |
| Address |
NIMHANS Bangalore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rupa Sanadi |
NIMHANS |
Nimhans Hospital, Hosur Road, Bangalore ... Address. No. 29, Marigowda Road, Hosur Road, Bangalore - 560029 (Near Bangalore Milk Dairy).
Bangalore
KARNATAKA |
8762839086
rupasanadi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NIMHANS Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F53||Puerperal psychosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Structured Family Psychoeducation programme |
Providing education to caregivers of women with postpartum psychosis like education on illness, management, communication skills, education on contraceptive, breastfeeding practices, mother-infant bonding and care and support system etc |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria of the caregivers: -
1.Caregivers are Mothers, Mothers-in-law, Spouses, and significant others of women with postpartum psychosis
2.Caregivers residing with women with postpartum psychosis for at least 15 days to 1-month period
3.Those who can speak Kannada and English.
4.Age range between the age group of 18-65 years.
5.Caregivers who can stay with women with postpartum psychosis after the discharge at least for 2- 3 months
Inclusion criteria of the patient: -
1.Women who are diagnosed with postpartum psychosis
2.Onset of illness within three months postpartum
3.Infant age up to 6 months
4.Mother and baby joint admission at MBU
5.Those who can speak Kannada and English.
6.Age above 18- years
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria of the caregiver: -.
1.Caregivers who are reported to have intellectual disability and significant neurological and mental disorders.
2.Caregivers who are not willing to give consent for the participation
3.Caregivers who are paid attenders and staying only at hospitalization
Exclusion criteria of the patient: -.
1.Women who are diagnosed to have an intellectual disability and major neurological conditions.
2.Women who are not willing to give consent for the participation
3.Women who have been diagnosed with chronic schizophrenia, OCD, PTSD, or Dissociative disorder with postpartum onset.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improve knowledge on illness and treatment
Reduce stress & burden |
Baseline, at discharge and 3 months after discharge
One years point of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Support from caregivers
Effective Problem solving & communication patterns among caregivers |
Baseline, at discharge and 3 months after discharge
One years point of time |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="40"
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)
|
06/05/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rupasanadi@gmail.com].
- For how long will this data be available start date provided 05-05-2025 and end date provided 05-05-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Researchers have undertaken this intervention study as data are scarce on structured family psychoeducation for caregivers of women with postpartum psychosis even though the study has found postpartum psychosis is an emergency condition. It requires the need to focus on family members’ involvement and provide information on illness conditions and reduce their burden. Considering this, the researcher has planned to develop an intervention package based on a scientific review of the literature to deliver an intervention. |