| CTRI Number |
CTRI/2021/01/030487 [Registered on: 15/01/2021] Trial Registered Prospectively |
| Last Modified On: |
22/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Psychosocial therapy for people with schizophrenia. A group of treatments will be offered to schizophrenia patients in this study to see the result of intervention. |
|
Scientific Title of Study
|
Psychosocial Interventions in Persons with Schizophrenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashfaq Ahmad Dangroo |
| Designation |
Research Scholar |
| Affiliation |
Government Medical College and Hospital Chandigarh |
| Address |
Hardushiva Sopore Baramulla, jammu and Kashmir, India 193201
Room No 308 Mental Health Institute Sector 32 Chandigarh
Baramula
JAMMU & KASHMIR
193201
India |
| Phone |
7006360294 |
| Fax |
|
| Email |
ashfaqad777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh Kumar Sahu |
| Designation |
Associate professor |
| Affiliation |
Government Medical College and Hospital, Sector-32, Chandigarh. |
| Address |
Room 226 Mental Health Institute
Sector 32 Chandigarh
sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9038751120 |
| Fax |
|
| Email |
withkamlesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priti Arun |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital Sector-32, Chandigarh |
| Address |
Department of Psychiatry
Government Medical College and Hospital Sector-32, Chandigarh
sector 32 Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121612 |
| Fax |
|
| Email |
drpritiarun@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital sector 32 Department of Psychiatry |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital Chandigarh |
| Address |
Government Medical College and Hospital sector 32 Department of Psychiatry 5th floor |
| Type of Sponsor |
Other [Government Medical College and Hospital Chandigarh] |
|
|
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 |
| Ashfaq Ahmad Dangroo |
GMCH 32 Chandigarh |
Department of Psychiatry, Government Medical College and Hospital, Sector-32, Chandigarh.
Chandigarh
CHANDIGARH |
7006360294
ashfaqad777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (GMCH Chandigarh) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not Applicable |
Not Applicable. There is no control group or comparison group. |
| Intervention |
Psychosocial Intervention in person with Schizophrenia |
1 Monitoring Compliance for Intervention through Morisky Medication Adherence Scale
It will be monitored if persons with schizophrenia are complying with both pharmacological and non- pharmacological treatment as prescribed by the clinician.After that a session will be taken to ensure patients compliance with both non pharmacological as pharmacological treatment.The session duration will be 1 hour and frequency will be weekly.Total sessions will be 8 in whole study
|
| Intervention |
Psychosocial Intervention in person with Schizophrenia |
Activity Scheduling and monitoring
To help persons with schizophrenia in scheduling various activities into day to day lifestyle and help them to identify a timetable of activities to manage their attention, develop feelings of competence, develop social confidence etc a written format of activity is scheduled and is monitored in each session to see if persons with schizophrenia are maintaining it.There will be one session in which activity scheduling will be done and patient will be instructed to follow the schedule. In each session this will be monitored by therapist. |
| Intervention |
Psychosocial Intervention in person with Schizophrenia |
Engagement in Vocation or Productive Work
If person with schizophrenia is functional then vocational counselling in order to involve him/her in some productive activity and then once client is ready then we proceed for it. After assessing if there is any kind of vocational help needed she or he can be helped to engage in it. The session will be weekly and duration will be 1 hour. |
| Intervention |
Psychosocial Intervention in person with Schizophrenia |
Intervention to address impaired socio-occupational functioning as per initial
assessment with Social Occupational Functioning Scale SOFS by Saraswat et al
2006
After assessing the SOF scale a complete picture will be found on the lacking area of persons with schizophrenia’s social occupational and functional life. As per requirement these issues to be addressed. The session duration will be 1 hour and frequency will be weekly. |
| Intervention |
Psychosocial Intervention in person with Schizophrenia |
Psychoeducation IPS guidelines by Sarkhel, Singh and Arora 2020
Goals of the psychoeducation will be following
To ensure basic knowledge and competence of patients and their relatives about the illness.
To provide insight into the illness
To promote relapse prevention
Engaging in crisis management and suicide Prevention if required through referral services.
Essential elements
1 Briefing the patients about their illness
2 Problem solving training
3 Communication training
4 Self-assertiveness training
the session duration will be 1 hour and frequency will be weekly two session will be taken on psychoeducation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Schizophrenia (only F20.0-20.9) as per ICD-10.
2 Clinically stable patients defined as absence of exacerbation of illness requiring increase in drug doses by 50 % in past three months.
3 Age 18 to 55 years.
4 Duration of schizophrenia more than 1 year and less then 5 years
5 Those who will give written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Any unstable major medical illness or substance dependence (except nicotine and caffeine).
• Those who are already receiving psychosocial intervention.
• Worsening of clinical condition while receiving psychosocial intervention |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the outcomes of psychosocial intervention in persons with schizophrenia
During intervention sessions their issues will be addressed as per the needs. Soon after the intervention, post assessment will be done assessing again on Global Assessment of functioning GAF, WHO-QoL-BREF and additionally on Patient satisfaction scale PAT-SAT. |
There will be 8 sessions in whole study and the session duration will be 1 hour and frequency will be weekly.The total time point will be 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the psychosocial needs and outcomes of intervention in persons with schizophrenia
To study the feasibility of psychosocial intervention in out patient clinic. |
This study includes intervention sessions which will be done on weekly basis and in 8 weeks 8 sessions will be completed. |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2021 |
| Date of Study Completion (India) |
30/07/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NA |
|
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 - Statistical Analysis Plan
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 - Any purpose.
- By what mechanism will data be made available?
Response (Others) - After the completion the research scholar may publish a research paper on this thesis that will be published in any journal.
- For how long will this data be available start date provided 01-07-2022 and end date provided 01-07-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - This is M.Phil thesis and the research paper will be published in any journal.
|
Brief Summary
Modification(s)
|
After receiving ethical clearance, those patients who are attending to psychiatry OPD and diagnosis with schizophrenia (F20.0-20.9) as per ICD-10 criteria and meting the inclusion and exclusion criteria and give consent for the study were initially assessed consecutively. Socio-demographic and Clinical details will be collected from the case record file and from the patient or care givers. A detail psychosocial assessment was done then Psychosocial Intervention Needs checklist will be filled based on the psychosocial assessment and information from the patients then they were assessed on Global Assessment of functioning (GAF), WHO-QoL-BREF. Subsequently, sessions were planned as per the intervention package (psychosocial intervention) was proceeded along with the routine treatment from the OPD.
All interventions in the package will not be applicable for all the patients it will be specifically made for each person with schizophrenia depending upon the score of socio occupation functioning scale. After that during intervention sessions their issues were addressed as per the needs. Soon after the intervention, post assessment will be done assessing again on Global Assessment of functioning (GAF), WHO-QoL-BREF and additionally on Patient satisfaction scale (PAT-SAT). |