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CTRI Number  CTRI/2024/11/077267 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 21/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Social Work Intervention Module on caregievrs burden and coping mechanishm of caregivers of person with Severe Psychiatric Disorders 
Scientific Title of Study   Caregivers experiences and Coping Mechanisms among family caregivers of persons with Severe Psychiatric Disorders 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Upendra Singh 
Designation  Lecturer 
Affiliation  ABVIMS Dr Ram Manohar Lohia Hospital New Delhi 
Address  Room No 16 Department of Psychiatry gate No 9 Dr Ram Manohar Lohia Hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  9598633838  
Fax    
Email  pswupendra@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Upendra Singh 
Designation  Lecturer 
Affiliation  ABVIMS Dr Ram Manohar Lohia Hospital New Delhi 
Address  Room No 16 Department of Psychiatry gate No 9 Dr Ram Manohar Lohia Hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  9598633838  
Fax    
Email  pswupendra@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Upendra Singh 
Designation  Lecturer 
Affiliation  ABVIMS Dr Ram Manohar Lohia Hospital New Delhi 
Address  Room No 16 Department of Psychiatry gate No 9 Dr Ram Manohar Lohia Hospital New Delhi

New Delhi
DELHI
110001
India 
Phone  9598633838  
Fax    
Email  pswupendra@gmail.com  
 
Source of Monetary or Material Support  
Room No 16 Department of Psychiatry gate No 9 Dr Ram Manohar Lohia Hospital New Delhi-110001 
 
Primary Sponsor  
Name  Upendra Singh 
Address  Room No 16 Department of Psychiatry gate No 9 Dr Ram Manohar Lohia Hospital New Delhi-110001 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Upendra singh  Atal Bihari Bajpai Institute of Medical Scinces-Dr Ram Manohar Lohia Hospital  Room No 16 Department of Psychiatry gate No 9,
New Delhi
DELHI 
8969126214

pswupendra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, ABVIMS, Dr. RML Hospital, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of Individuals diagnosed with severe psychiatric illness 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Social Work Intervention  Only medication they will get, after 3 month they will assess again. 
Intervention  Social Work Intervention  Pre and Post Intervention will be given 14 session which will take weekly session for three months 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1-Care Givers of Person with Schizophrenia and Bipolar Affective Disorders
2-Age 25-60 Years
3-Care Givers engage in careing more than 6 months

 
 
ExclusionCriteria 
Details  1-Care Givers with any serious and long term or Psychiatric Illness
2-Any other family member has mental illness or physical illness in family
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluate the Social Work Intervention module impact on caregievrs burden and coping mechanishm of individual of severe psychiatric disorders. assess the quality of life of caregivers  after 14 weeks post assessment will be done to assess impact of intervention module 
 
Secondary Outcome  
Outcome  TimePoints 
Overall Improvment to reduce on caregivers burden an enhance coping mechanism of careegivers of individual of severe psychiatric disorders  Pre & Post intervention study for 12 weeks (per week session will be taken). will compare 4th week 8th week & after the intervention 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   18/12/2024 
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="0"
Months="3"
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 - NO
Brief Summary  

METHODOLOGY

Main aim of this current study was to evaluate the impact of social work intervention module on

The current study assessed the relationship between the care giving variables and the intervention provided to the participants. It also assessed the outcome of the intervention provided to the participants. Psychotherapy aims at allevating distress, burden and pain that fills the cognition, emotions, and behaviour of an individual. The current syudy used the traditional psychotherapy refering to psychological approaches to interven the distress, burden and pain of an individual. Thus, client-centered approach was the prime aproach to design the intervention module for the caregivers. Caregivers deal and experience with the inabilities, cognitive delays, and limited interpersonal responses of the mentally ill in the family. In addition to these, caregivers have to continuously deal with the oppressive burden of societal stigma, alongwith managing the conditions of the mentally ill, caregivers have to fulfill double or more responsibilities for the household. These longlasting and chronic stressful condition leads to piling of emotional distress, negative self-evaluation, anxiety, low stress tolerance, poor coping strategies, poor problem solving skills, and dysfunctional interpersonal habits. In India there is a huge amount of people suffering with severe psychiatric disorders and thus, a larger number of family caregivers are there spending significant amount of their daily life on them. To help these caregivers take better care of their loved ones it is important that caregiver’s psychological and social wellbeing is taken into consideration.

The Ethics committee of the institute granted permission to conduct research on an ethical basis. Study was conducted at department of Center of Excellence in Mental Health, AtalBihari Vajpayee Institute of Medical Sciences & Dr. Ram Manohar Lohia Hospital in New Delhi.

Two stages of sampling were employed: in the first, participants (after screening) were chosen on purposively, and in the second, experimental and control groups were created using a systematic random sampling. Inpatient and outpatient department (OPD) were used for the selection of participants. Thirty subjects in total were recruited, along with their spouses. Before receiving written consent, they were informed about the study’s objectives and procedure. Total 30 caregivers of individual with Schizophrenia and Bipolar affective disorders were included in the study according to ICD-10.

Social Work Intervention Module

Session

Technique

Target

Component of Therapy

1

Psychoeducation

To create insight into the nature, course, & treatment of the disorder

Empathy, Informative model, Supportive attitude

2

Ventilation of emotion

Releasing of fears, anxiety, burden, communication and interpersonal problems, thinking process

Active listening, empathy, supportive attitude

3

Relaxation

Regulation of anxiety, emotional expressions, and meta-cognitive errors.

Deep Breathing, Using of five senses, Living in the present, Letting go, Non-judgemental attitude

4

Communication Skills

To modify and reduce expressed emotion

Feedback, Active listening & effective questioning, understanding non-verbal cues and body language, expression of empathy

5

Group Session

Imparting information, Catharsis, Instillation of hope

Active listening, empathy, supportive attitude

6

Distress Tolerence Skills

 

Enhancing Self-efficacy, being gental with self, developing positive attitude

Radical acceptance, distraction, Self-soothing activities, Directing strength, Self-encouragement, & Self-affirmation

7

Cognitive Restructuring for Coping Strategies

Cognitive distrotions & thinking errors

Based on here & now principle, Reality oriented,

8

Cognitive Restructuring for Coping Strategies

Poor coping strategies

Based on here & now principle, Reality oriented, Self-monitoring

9

Group Session

Catharsis, Self-understanding, Existential factors

Active listening, empathy, supportive attitude

10

Cognitive Restructuring for Problem solving strategies

Enhancing problem solving skills for day to day activities.

Focus on the solution, not the problem, simplify   things, listing out as many solutions as possible, think laterally.

11

Interpersonal Effectiveness Skills

Developing interpersonal skills to enhance healthy relationship

Learning skills to express self-needs, Learn to say No, & Learn to negotiate conflicting needs without ending in a fight

12

Role restructuring

To redifine role and responsibilities

Role reversal and role play

13

Group Session

Corrective recapitulation of family experience, development of socialization techniques, interpersonal learning

Active listening, empathy, supportive attitude

14

Termination

Termination with post-assessment

 

Emphasizing the change made during intervention

 

 
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