A trial to study the usefulness of Tamil version of Integrated Psychological Therapy in Patients with Schizophrenia in Coimbatore
- Conditions
- Schizophrenia,
- Registration Number
- CTRI/2019/02/017569
- Lead Sponsor
- Dr B Ravishankar
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 70
- 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.
1)Persons of any co-morbid psychiatric disorder, neurological disorders 2)History of substance or alcohol, formal thought disorder, aggressive behavior 3)IQ <70.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The scores on cognitive domains measured, which are: two weeks,6 months and one year after the intervention 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 Measures
Name Time Method 1) Negative Symptoms Scores of the PANSS (Positive and Negative Syndrome Scale) 2) Social functioning (as assessed by World Health Organization Disability Assessment scale)
Trial Locations
- Locations (1)
Krishna Nursing Home
🇮🇳Coimbatore, TAMIL NADU, India
Krishna Nursing Home🇮🇳Coimbatore, TAMIL NADU, IndiaDrRavishankarPrincipal investigator9443336742drravishankarbalu@gmail.com