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CTRI Number  CTRI/2024/05/068132 [Registered on: 31/05/2024] Trial Registered Prospectively
Last Modified On: 27/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Leisure-based occupational therapy for individuals with schizophrenia. 
Scientific Title of Study   Effectiveness of leisure-based intervention among individuals with schizophrenia on cognitive domains and self-esteem: A mixed-method study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amar Arvind Nishad 
Designation  Assistant Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104

Udupi
KARNATAKA
576104
India 
Phone  9137506075  
Fax    
Email  nishad.amar@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Anil Kumar Mysore Nagraj 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal- 576104

Udupi
KARNATAKA
576104
India 
Phone  9901911667  
Fax    
Email  anilkumar.nagaraj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Anil Kumar Mysore Nagraj 
Designation  Associate Professor 
Affiliation  Manipal Academy of Higher Education 
Address  Department of Psychiatry, Kasturba Medical College, Manipal Academy of Higher Education, Manipal- 576104

Udupi
KARNATAKA
576104
India 
Phone  9901911667  
Fax    
Email  anilkumar.nagaraj@manipal.edu  
 
Source of Monetary or Material Support  
Room no. 311, Department of occupational therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi- 576104, Karnataka, India. 
 
Primary Sponsor  
Name  Department of occupational therapy 
Address  Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal- 576104 
Type of Sponsor  Private 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 
Amar Nishad  Kasturba Hospital  Room no. 311, Kasturba Hospital, Tiger Circle Rd. Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA 		 9137506075

nishad.amar@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F20||Schizophrenia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Health education on lifestyle modification  Participants in the control group will receive health Education on lifestyle individually or in group for about 45 minutes- 60 minutes twice a week for three weeks at the project site, individually or in groups of two to three, and researcher contact will be shared for any doubts. Subjects attending at least 4 out of 6 sessions will be considered to have completed the study. Follow up assessment once a month for 3 months.  
Intervention  leisure-based intervention  Leisure-based intervention group will receive the intervention for about 45 minutes -60 minutes of duration individually or in groups of two to three, twice a week at the project site for three weeks, with homework sessions and reminders will be given with diary to track the activity. Any subject attending at least 4 out of 6 sessions will be considered to have completed the study. We will also involve the family members to remind about the activity and date of the upcoming session and researchers contact information will be shared for any doubts. We will have categories and sub-categories of intervention which might include activities like Arts and Craft activities, Physical Exercise, Sport, puzzles, Board games, Group discussions, Psychoeducation on importance of leisure activities can be conducted as part of the sessions based on the evidence. However, the final intervention will be ready after the phase one. Follow up assessment once a month for 3 months.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Individuals with diagnosis of Schizophrenia with score of less than 4 on items of positive symptoms on BPRS scale
2. The participant should be able to give informed consent.
3. The Participant who can speak English or Hindi or Kannada
4. If the participant has a history of longitudinal comorbid psychiatric diagnosis which is currently stable and not on treatment for the same will be included
 
 
ExclusionCriteria 
Details  1. Acute medical co-morbidities such as uncontrolled HTN, Asthma, that affect study participation as well as act as confounding factors
2. Acute Psychiatric co-morbidities affecting participation in the study,
3.Suicidal thoughts
4. Physical disabilities affecting participation in the study,
5. Substance use other than nicotine,
6.In Depression Anxiety Stress Scale (DASS-21) score of more than 4 on depression, more than 3 on anxiety, and more than 7 on stress
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Cognitive domains using The Montreal Cognitive Assessment (MoCA)
2. Self-esteem level using Rosenberg self-esteem scale 		 At baseline, at 4 weeks, at 8 weeks, and at 12 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
1. social functioning using The Personal and Social Performance (PSP)
2. Physical activity levels using The International Physical Activity Questionnaire (IPAQ-SF)
3. Quality of life using The WHO Quality of Life-BREF (WHOQOL-BREF)
 		 At baseline, at 4 weeks, at 8 weeks, and at 12 weeks. 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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 3 
Date of First Enrollment (India)   19/06/2024 
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="3"
Months="6"
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  

This study is a mixed method design in which there will be two phases.

Phase 1 will be to develop leisure-based intervention among individuals with schizophrenia.

 

Phase 2 will be to assess the effectiveness of leisure-based intervention among individuals with schizophrenia in Karnataka, India.

Primary outcome measures will be cognitive domains and self-esteem levels. The Secondary outcomes will be negative symptoms, quality of life, physical activity levels, and social functioning.

 
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