FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/02/017658 [Registered on: 14/02/2019] Trial Registered Prospectively
Last Modified On: 21/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral
Other (Specify) [Supportive Therapy ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To study the effectiveness of psychological therapy in patients with schizophrenia  
Scientific Title of Study   A randomized control trial to study the efficacy of Tamil version of Metacognitive Training in patients with schizophrenia in Coimbatore 
Trial Acronym  MCT  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr B Ravishankar 
Designation  Consultant Psychiatrist 
Affiliation  Krishna Nursing Home 
Address  Clinical Trial Room,Psychiatry Department 3rd floor Krishna Nursing Home 6AB, Swaranambika Layout Ramnagar, Coimbatore 641 009
6AB, Swaranambika Layout Ramnagar, Coimbatore 641 009
Coimbatore
TAMIL NADU
641009
India 
Phone  9443336742  
Fax  0422234508  
Email  drravishankarbalu@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B Ravishankar 
Designation  Consultant Psychiatrist 
Affiliation  Krishna Nursing Home 
Address  Admin room, 1st floor Krishna Nursing Home 6AB, Swaranambika Layout, Ramnagar, Coimbatore 641 009
6AB, Swaranambika Layout, Ramnagar, Coimbatore 641 009
Coimbatore
TAMIL NADU
641009
India 
Phone  9443336742  
Fax  0422234508  
Email  drravishankarbalu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr B Ravishankar 
Designation  Consultant Psychiatrist 
Affiliation  Krishna Nursing Home 
Address  1st Floor, admin room Krishna Nursing Home 6AB, Swaranambika Layout Ramnagar, Coimbatore 641 009
6AB, Swaranambika Layout Ramnagar, Coimbatore 641 009
Coimbatore
TAMIL NADU
641009
India 
Phone  9443336742  
Fax  0422234508  
Email  drravishankarbalu@gmail.com  
 
Source of Monetary or Material Support  
Krishna Nursing Home 6AB, Swaranambika Layout, Ramnagar, Coimbatore, 641009 
 
Primary Sponsor  
Name  Dr B Ravishankar  
Address  6AB, Swaranambika Layout, Ramnagar, Coimbatore 641 009 
Type of Sponsor  Other [Principal Investigator] 
 
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 
DrBRavishankar  Krishna Nursing Home   3rd Floor, Clinical Trial Room Department of Psychiatry Krishna Nursing Home 6AB, Swaranambika Layout Ramnagar, Coimbatore 641 009
Coimbatore
TAMIL NADU 		 9486122411
0422234508
drravishankarbalu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Krishna Nursing Home  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 
Intervention  Metacognitive Training  Schizophrenia is a neuropsychiatric disorder which predominantly affects thought processes and neurocognition. Researches have shown that patients with schizophrenia quickly jump to conclusions about an event without considering all the possible causes for the event. They have difficulty in understanding other’s thoughts and emotions in social situation which leads to impairment in their social functioning. They make hasty decisions without considering all the possible causes of an event which includes how the patients themselves, others or the environment could be responsible for the event. Literature indicates distress in patients with schizophrenia is related to erroneous processing of information which leads to patient focusing on threat and thought control. These processes are closely associated with belief about the patient’s usefulness and controllability. Metacognitive therapy which is a combination of cognitive remediation therapy, cognitive behavior therapy, social cognition and psychoeducation, aims to raise awareness about cognitive biases which contributes to developing or maintaining the disorder particularly delusions. The goal of metacognitive therapy is to ‘sow the seeds of doubt’ through encouraging patients to develop an impersonal awareness of their thoughts and to increase control over unhelpful information processing strategies. This is done in an entertaining, non-judgemental, playful and collaborative manner by initially discussing everyday scenarios (non-delusional) progressing to scenarios where the treat might be exaggerated by the patient. Metacognitive therapy involves 10 modules which target cognitive bias individually by pointing out the fallibility of human cognition in general. Through exercises patients are taught to recognize, counter think biases. In therapy patients are taught to discuss alternative information processing strategies by guiding them to process their surroundings accurately.  
Comparator Agent  Treatment as Usual  Patients will be following their regular psycho-pharmacological treatment involving medication, psycho-education of patients and family, relaxation therapy, occupational therapy and followups with the consultant psychiatrist 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.primary diagnosis of schizophrenia confirmed by Mini International Neuropsychiatric Interview (M.I.N.I), supplemented by DSM-V and clinical diagnosis.
2.participants should have at least 8 years of education
3.participants should have provided informed consent
4.participants should be able to read and speak Tamil language
5.all participant should be symptomatically stable at the time of enrollment,
6.Positive and Negative Syndrome Scale (PANSS) scores should be under 75, ratings of 3 (mild) or less on the PANSS psychosis items.  
 
ExclusionCriteria 
Details  1.any co-morbid psychiatric disorder, neurological disorders
2.history of substance or alcohol, formal thought disorder, aggressive behavior
3.IQ <70 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Outcome Name:
• Score on Positive and Negative Symptom Scale (PANSS)
Expected Outcome:
• The experimentalintervention group is expected to show 40% reduction in the PANSS score whereas the control or the treatment as usual group is expected to show 10% reduction in the PANSS score.
 		 After 2 weeks, 6 months and 1 year of completion of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
•To study the effect of metacognitive therapy on patient’s insight
•To study the relationship of positive symptom(as assessed by PANSS)and insight
•To study the effect of metacognitive therapy on the patient’s beliefs
•To study if the metacognitive therapy improves patient’s metacognitive functioning
•To study if effect of metacognitive therapy on patient’s functioning 		 2 weeks, 6 months and one year after the intervention termination. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/03/2019 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   The study is a randomized control trial, a parallel group design with allocation ratio of 1:1, conducted at Krishna Nursing Home, Coimbatore.The two arms of the trial are: metacognitive training (experimental arm) and (active control arm) treatment as usual (TAU). The aim of the trial is to study the efficacy of Tamil version of metacognitive training.The primary outcome will be the score on Positive and Negative Symptom Scale measured two weeks after the intervention.The secondary outcomes will be score on Positive and Negative Symptom Scale measured 6 months and one year after the intervention termination, effect of metacognitive training on patient’s insight( as assessed by Beck’s Cognitive Insight Scale), relationship of positive symptoms and insight, effect of metacognitive training on patient’s belief (as assessed by Brown’s Assessment of Belief Scale), if metacognitive training improves patient’s metacognitive functioning ( as assessed by scores of metacognitive assessment scale) and to study the effect of metacognitive training on patient’s functioning (as assessed by World Health Organization Disability Assessment scale).The final outcome will be analyzed on intention to treat basis.The outcome assessors in the trial will masked to the allocation details. The metacognitive training, comprises of 10 modules consisting of PowerPoint slides. Each module addresses cognitive biases in a way that explains how they contribute to the formation of delusion followed by specific exercises to raise awareness about negative consequences of cognitive biases and concludes with learning aims and alternative thinking strategies to help them avoid cognitive biases that can lead to delusional beliefs. The therapy is intended as a supportive therapy along with the pharmacological treatment, aims to increase metacognitive awareness in patients.It is expected to reduce positive symptoms by making patients aware of  their cognitive experiences facilitating adaptive responses and act prophylactically against relapse. Each session will last between 45 to 60 minutes.The participants will be block randomized and stratified according to participant’s age and years since diagnosis. 
Close