| 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
|
|
|
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
|
|
|
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
|
|