| CTRI Number |
CTRI/2019/02/017569 [Registered on: 08/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial to study the usefulness of Tamil version of Integrated Psychological Therapy in Patients with Schizophrenia in Coimbatore |
|
Scientific Title of Study
|
A Randomized Control Trial to Study the Efficacy of Tamil Version of Integrated Psychological Therapy in Patients with Schizophrenia in Coimbatore |
| Trial Acronym |
RCT of IPT |
|
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 |
Principal Investigator |
| Affiliation |
Krishna Nursing Home |
| Address |
Clinical Trial Room, 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 |
919486122411 |
| Fax |
0422234508 |
| Email |
drravishankarbalu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Ravishankar |
| Designation |
Principal Investigator |
| Affiliation |
Krishna Nursing Home |
| Address |
Clinical Trial Room, 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 |
919486122411 |
| Fax |
0422234508 |
| Email |
drravishankarbalu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Ravishankar |
| Designation |
Principal Investigator |
| Affiliation |
Krishna Nursing Home |
| Address |
Clinical Trial Room, 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 |
919486122411 |
| Fax |
0422234508 |
| Email |
drravishankarbalu@gmail.com |
|
|
Source of Monetary or Material Support
|
| 6AB, Swaranambika Layout, Ramnagar
Coimbatore 641009
Krishna Nursing Home |
|
|
Primary Sponsor
|
| Name |
Dr B Ravishankar |
| Address |
6AB, Swaranambika Layout, Ramnagar, Coimbatore 641 009 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 |
| DrRavishankar |
Krishna Nursing Home |
6AB Swaranambika Layout Ramnagar Coimbatore641 009
Coimbatore
TAMIL NADU |
9443336742
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated Psychological Therapy |
Integrated Psychological Therapy (IPT) is a systematically structured comprehensive integrated holistic therapy approach for schizophrenia.IPT is founded on the assumption that the basic deficits in neurocognitive functioning have a pervasive effect on higher levels of behavioural organization.
It is a group therapy, encouraged interactions between patients. The therapy involves card sorting exercise and discussing emotions in a set of slides.
It is established on the premise that basic neurocognitive and social cognitive development precedes development of complex interactional functioning. The intervention focuses on social cognition and social competence in addition to neurocognition
IPT includes the subprograms namely: cognitive differentiation, social perception, verbal communication, social skills and interpersonal problem solving.
The first subprogram of cognitive differentiation focuses on deficits in neurocognition (e.g., attention, verbal memory, cognitive flexibility, concept formation). The second subprogram of social perception focuses on deficits (social and emotional perception). The fourth and fifth subprograms social skills and interpersonal problem solving focus on developing patient’s social competence by practicing interpersonal skills (role play) and group based problem solving exercises. The third subprogram of verbal communication serves as a bridge between the first two and the last two subprograms. It targets neurocognitive skills which have a strong relationship with interpersonal communication, such as verbal fluency and executive functioning. |
| 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 The Mini International Neuropsychiatric Interview, (M.I.N. I) and supplemented by DSM-V
2)participants should have at least 8 years of education
3) able to read and speak Tamil language
4) all participants should be symptomatically stable at the time of enrollment
5) 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)Persons of 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 |
The scores on cognitive domains measured, which are:
Trail Making Test Part A, Wechsler’ subtests of Digit Span, Digit Symbol and Picture Arrangement, Rey–Osterrieth complex figure, Rey Auditory Verbal Learning Test, PGI Memory Scale |
two weeks,6 months and one year after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Negative Symptoms Scores of the PANSS (Positive and Negative Syndrome Scale)
2) Social functioning (as assessed by World Health Organization Disability Assessment scale)
3) Insight (Beck’s Cognitive Insight Scale)
4) Belief (as assessed by Brown’s Assessment of Belief Scale)
5) Metacognition (as assessed by Metacognition Assessment Scale) |
two weeks,6 months and one year after the intervention |
|
|
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)
|
12/03/2019 |
| 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
Modification(s)
|
Years="0"
Months="8"
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, parallel group design with allocation ratio of 1:1, conducted at Krishna Nursing Home, Coimbatore.The two arms of the trial are: Integrated Psychological Therapy (experimental arm) and Treatment as usual (active control arm). The aim of the trial is to study the efficacy of the Tamil version of Integrated Psychological Therapy. Schizophrenia is a mental illness characterized by positive, negative, cognitive and mood symptoms. Studies have shown that cognitive variables are important predictors of patient’s functional outcome in spite of remission of positive and negative symptoms. Cognitive deficits which have a direct link with the functional outcome as proven by numerous studies continue to persist even as patients are clinically ’stable’.Cognition is studied as the primary outcome measure. The domains of cognition undertaken are speed of processing, attention/vigilance, working memory (non-verbal), working memory (verbal), verbal learning, visual learning, problem solving and social cognition. The proposed group intervention Integrated Psychological Therapy, focuses on rehabilitation of social cognitive and neurocognitive deficits among patients with schizophrenia.The therapy modules focus on developing the ability to regulate emotion and coping with emotional stress. The exercises are affectively neutral in the beginning and gradually advances to more complex and difficult tasks. The therapist is actively involved in the session, who is responsible for mediating and making the patient recognize appropriate and inappropriate show of emotion and discuss effective problem solving strategies.The project is unique in studying the treatment effectiveness of Tamil version of the therapy.It is expected that since literature suggests cognition as a strong predictor of functional outcome, remedying cognitive deficits would improve patient’s overall functioning and improve their employability |