Adaptation and feasibility of Social Cognition and Interaction Training (SCIT) for persons with Schizophrenia

Not yet recruiting

• Conditions: Schizophrenia,

• Registration Number: CTRI/2022/04/042305
• Lead Sponsor: NIMHANS

Brief Summary

**Aim and Objectives:** The primary aim of this study is to adapt *Social Cognition and Interaction Training (SCIT)* to an Indian Context and evaluate its feasibility in patients with Schizophrenia.  Following are the  objectives as per the phase in which the study will take place:

 Phase I:

To adapt *SCIT* to an Indian context.

Phase II:

To evaluate the feasibility of a contextually adapted intervention for social cognition in patients with schizophrenia.

(1)   To examine the rate of recruitment to the study among eligible patients with schizophrenia.

(2)   To examine the attrition rate among eligible patients consenting to receive the intervention.

(3)   To examine the acceptability of the intervention among eligible patients receiving the intervention.

(4)   To conduct limited efficacy testing of the adapted intervention on outcome measures of social cognition, symptoms of schizophrenia, neurocognition,   recovery, quality of life, and disability.

 **Background and Rationale:** Social cognition refers to mental operations that underlie social interactions, including perceiving, interpreting, and generating responses to the intentions, dispositions, and behaviors of others. Social cognition is considered to have four primary domains: emotional and social perception, theory of mind (ToM), and attributional style. Social Cognition has been identified as a deficit consistently across various stages and episodes in persons with Schizophrenia. In the Indian context, though social cognition as a domain has been researched along with the adaptation of tools to measure social cognition, published research on comprehensive interventions for social cognition as well as their availability and implementation is limited. Hence, it was decided to adapt called *“Social Cognition and Interaction Training (SCIT)â€* in an Indian context, which has efficacy in various settings and has been adapted in various countries. This intervention widely covers the domains of social cognition and approaches intervention purely from a social cognitive perspective while taking a practical standpoint. It is thus important to have a contextualized intervention that is also feasible to use.

**Method:** This study will follow an open-label design with a single-arm experimental research design with baseline, post-module (aspects of acceptability), and post-intervention assessments. This study will be conducted in two main phases wherein the first phase would involve adaptation (in terms of the process, duration, frequency, mode of delivery, content, language, images, video, audio files, etc.) of the intervention in consultation with the authors (with expert validation), and a pilot study for patients with schizophrenia early in their course.

The second phase of the study aims to evaluate the feasibility of the intervention in domains of acceptability, recruitment rate, attrition, and limited-efficacy testing (n=30) for patients with schizophrenia early in their course, with > 10 years duration of illness, between 18-50 years of age with minimum education till class 7. Some of the outcome measures associated with limited-efficacy testing include symptomatology, social cognition, neuro-cognition, recovery, quality of life, and disability. Towards the end, attempts will be made to manualize the adapted intervention and make it widely accessible for use.

**Analysis:** Appropriate statistical analysis techniques involving descriptive and inferential statistics will be used, along with thematic analysis for the qualitative aspects for interpretation.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-05
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 1. Persons diagnosed with Schizophrenia 2) Duration of illness <10 years 3) CGI score<3 4) Change of medications by less than 25% of their dose in the past 8 weeks 5) Minimum education up to class 7.
• 6. 18-50 years of age 7) Working knowledge of English or Hindi.

Exclusion Criteria

1. Co-morbid neurological conditions 2) History of head injury 3) Currentsubstancedependence,except nicotine 4) Clinical evidence of intellectual disability 5) Current symptoms of severe depression 6) Having undergone electroconvulsive therapy in the preceding six months 7) Having received social skills/cognition training of at least ten sessions in the past one year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is Social Cognition	Baseline and post-intervention.

Secondary Outcome Measures

Name	Time	Method
Symptomatology, neuro-cognition, recovery, quality of life and disability.	Other aspects of feasibility i.e. acceptability, attrition rate and rate of recruitment.

Trial Locations

Locations (1)

National Institute of Mental Health and Neurosciences; 🇮🇳 Bangalore, KARNATAKA, India

National Institute of Mental Health and Neurosciences

🇮🇳Bangalore, KARNATAKA, India

Upasana Ravinder

Principal investigator

9810792049

upasanaravinder@gmail.com