| CTRI Number |
CTRI/2024/10/075678 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Coping strategies for carers of Schizophrenic patients. |
|
Scientific Title of Study
|
Community Based Family Intervention module for The Caregivers of Persons with
Schizophrenia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kabyashree Borah |
| Designation |
Ph.D Scholar |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Department of Psychiatric Nursing,Academic Building, 3rd floor
Department of Psychiatric Nursing,Academic Building, 3rd floor, p.o.- Tezpur, pin- 784001
Sonitpur
ASSAM
784001
India |
| Phone |
7094375869 |
| Fax |
|
| Email |
kabyashreeborah3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunjyoti Baruah |
| Designation |
HOD & Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Academic Building, 3rd floor, Department of
Psychiatric nursing,
LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
9435380045 |
| Fax |
|
| Email |
arunjyotibaruah@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunjyoti Baruah |
| Designation |
HOD & Professor |
| Affiliation |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
| Address |
Academic Building, 3rd Floor, Department of
Psychiatric nursing,
LGBRIMH, Tezpur
Sonitpur
ASSAM
784001
India |
| Phone |
9435380045 |
| Fax |
|
| Email |
arunjyotibaruah@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Mahabhairab, PO Sonitpur Pin 784178, Contact no. 03712233340 |
|
|
Primary Sponsor
|
| Name |
Kabyashree Borah |
| Address |
Department of
Psychiatric nursing,
LGBRIMH, Tezpur
pin- 784001, state- Assam, Country- India |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Arunjyoti Baruah |
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health |
Academic Building, 3rd floor, department of Psychiatric Nursing, PIN: 784001
Sonitpur
ASSAM |
9435060538
arunjyotibaruah@yahoo.com.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LGB Regional Institute of Mental Health Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy caregivers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Family Intervention Module |
The intervention module will be developed after the completion of 1st phase, where the needs of the caregivers will be identified through focus group discussions. The duration of each intervention under the module will take approximately 30 mins. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Primary caregivers of persons with schizophrenia
2. Caregivers who have stayed with the patient and provided care for six months or above
3. Aged between 18 years to 59 years
|
|
| ExclusionCriteria |
| Details |
1. Caregivers who are not willing to participate
2. Caregivers with known Psychiatric and physical Illness
3.Difficulty hearing or speaking
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the socio-demographic profile of the caregivers of persons with schizophrenia.
2. To explore the needs of the caregivers of persons with schizophrenia.
3. To develop a Family Intervention Module for the caregivers of Schizophrenia based on the identified needs.
|
1 and 2 at baseline
3rd outcome at 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Family Intervention Module among caregivers of persons with schizophrenia through pilot- testing. |
at 4th week after the application of the module. |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/11/2024 |
| 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="2"
Days="2" |
|
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 - NO
|
|
Brief Summary
|
TITLE OF THE STUDY: Community Based Family Intervention module for The Caregivers of Persons with Schizophrenia. BACKGROUND OF THE STUDY: Schizophrenia is a severe, persistent and disabling chronic mental disorder affecting more than 21 million people worldwide and has a high disease burden. Family caregivers play crucial roles in taking care of people experiencing schizophrenia in the community. This study aims to explore the needs of family caregivers of people experiencing schizophrenia in the communities of Assam in terms of the burdens of care and further need for support in order to provide guidance to health care providers regarding how to target therapeutic interventions for families of individuals experiencing schizophrenia. The family may itself be burdened by the enormous hardships created by the person with schizophrenia. An illness like schizophrenia is serious and disabling and causes an emotional and financial brunt on the supporting family members. AIM: The proposed study aims to explore the needs of the caregivers of persons with schizophrenia with a view to develop a Family Intervention Module based on Expressed Emotion and to test the efficacy of that module among caregivers of Schizophrenia through pilot testing. METHODOLOGY: The proposed study is going to adopt a mixed method approach where the 1 st phase will be conducted in qualitative (Phenomenological) design to assess the needs of the caregiver which will provide the basis to develop the Family intervention module. Data will be collected from a combination of participants i.e. caregivers of persons with Schizophrenia visiting various Community extension camps organized by LGBRIMH in 4-6 focused group discussion by using a semi structured interview guide. Phase 2: will be decided after the need assessment. Tools: Socio-demographic profile of the caregivers and clinical variables of the persons with schizophrenia and a semi structured interview guide will be used in phase I. ANALYSIS: Based on the transcripts from the interview after coding and recoding, through inductive content analysis, themes and subthemes will be identified for phase I. CONCLUSION: The symptoms not only impact patient but also the family members and the community in turn. From the literature it was found that nursing interventions along with the psychopharmacologic agent and somatic treatment were found to be effective for treatment of negative symptoms. Therefore, the researcher wants to develop a module comprising of nursing interventions with the aim to improve the quality of life and attitude of the primary care givers. |