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Clinical Trials/NCT04428996
NCT04428996
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Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness

National Cheng-Kung University Hospital1 site in 1 country30 target enrollmentJune 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Disorder
Sponsor
National Cheng-Kung University Hospital
Enrollment
30
Locations
1
Primary Endpoint
Ambiguous Intentions Hostility Questionnaire #Change from baseline at 20 weeks and 40 weeks
Last Updated
5 years ago

Overview

Brief Summary

Social cognition dysfunction (including emotional perception, theory of mind, and attribution bias) is a common dysfunction in serious mental illness, which may influence their life roles and daily functions. The social cognition and interaction training (SCIT) is a manual-guide group intervention that can apply to people with serious mental illness.Thus this study aims to conduct SCIT groups in Taiwan to investigate its feasibility and effectiveness.

This study will include 30 clients. Investigators will randomly allot participants into two group, and conduct a crossover design. The experimental group will receive a 60-minutes manual-guide SCIT session each week for 20 times, which will be leaded by 2 licensed occupational therapists. After the intervention, investigators will analyze demographic data and compare the difference between experimental group and control group on the social cognition performance.

Detailed Description

Social cognition dysfunction (including emotional perception, theory of mind, and attribution bias) is a common dysfunction in serious mental illness, which may influence their life roles and daily functions. The social cognition and interaction training (SCIT) is a manual-guide group intervention that can apply to people with serious mental illness. There have been evidences showing that the SCIT could improve emotional perception, theory of mind, attribution bias, and social relationship. However, there are no SCIT studies in Taiwan yet. Thus this study aims to conduct SCIT groups in Taiwan to investigate its feasibility and effectiveness. This study will include 30 clients from a day care ward and community rehabilitation center, excluding clients with acute onset, brain injury, intellectual disability and substance abuse. The investigators will randomly allot participants into two group, and conduct a crossover design. Before and after the intervention protocol, both group receive evaluations of clinical symptoms, emotional perception, theory of mind, and attributional bias. The experimental group will receive a 60-minutes manual-guide SCIT session each week for 20 times, which will be leaded by 2 licensed occupational therapists. There are three main themes of the SCIT: 1) introduction and emotion, 2) figuring out situation and 3) integration: checking it out. After each theme of the intervention, participants will fill out a satisfaction survey. And a senior occupational therapist will observe the group and rate the fidelity of the group. The control group will receive treatment as usual. After the intervention, the investigators will analyze demographic data and compare the difference between experimental group and control group on the social cognition performance.

Registry
clinicaltrials.gov
Start Date
June 2020
End Date
December 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • diagnosis of mental illness

Exclusion Criteria

  • acute hospitalization within the past two months
  • other diseases that may affect cognitive function, such as intellectual disability, substance abuse

Outcomes

Primary Outcomes

Ambiguous Intentions Hostility Questionnaire #Change from baseline at 20 weeks and 40 weeks

Time Frame: baseline, 20th week, 40th week

This is a measure of the attribution of the subject to the event, including 5 negative situations. Ask the subject to imagine that they are the protagonist in the situation. The first question responds to others' reasons for themselves. The second question is 6 The Likert scale (1 is absolutely not, 6 is absolutely yes) whether responding to others is intentional, the third question is to respond to your own with a 5 point Likert scale (1 is completely not, 5 is very angry) The degree of anger, the fourth question is also the degree of blaming others with a 5-point Likert scale (1 is not at all, 5 is absolutely), and finally asked the subjects to respond to the actions they will take; first Questions and the fifth question are evaluated by the evaluator based on his response. This is a tool with good reliability and validity, including internal consistency (alpha = .84 \~ .86) and inter-tester reliability (ICCs = .91 \~ .99).

Test of Theory of mind #Change from baseline at 20 weeks and 40 weeks

Time Frame: baseline, 20th week, 40th week

Includes language theory of mind and non-verbal theory of mind. Language theory of mind mainly measures the ability of cognitive components and emotional components. There are ten major questions, each of which contains four sub-questions. The first sub-question is a memory question, which must be answered correctly. The scores of the other three sub-questions are calculated. The full score of the language assignment is 30 points. There are ten questions in total, and the full score for non-verbal theory of mind is 20 points. About the internal consistency reliability, the language part is .91 and the non-verbal part is .93. About the test-retest reliability, the language part is .89 and the non-verbal part is .88.

Attributional Style Questionnaire #Change from baseline at 20 weeks and 40 weeks

Time Frame: baseline, 20th week, 40th week

This is a questionnaire to assess the social cognition of the subjects, including the theory of mind, cognitive schema and verbal memory. There are 10 scenarios, each of which contains 3 yes-or-no questions, and one question is about degree of judgment. The scoring method is scoring according to three sub-items. The content of the response of the subjects is compared with the norm. If it is lower than two standard deviations, the degree is disabled.

Diagnostic Analysis of Nonverbal Accuracy, Taiwanese version #Change from baseline at 20 weeks and 40 weeks

Time Frame: baseline, 20th week, 40th week

The DANVA-2-TW, a parallel version of the Diagnostic Analysis of Non-verbal Accuracy 2 (Nowicki and Duke, 1994), is a validated (Pan et al., 2009; Tseng et al., 2013), culturally suitable (Tseng et al., 2012) nonverbal measure for Han Chinese, considering that race and culture may considerably affect the accuracy of judging nonverbal emotions (Jack et al., 2012; Wickline et al., 2009). The DANVA-2-TW comprises 60 facial photographs and 60 voice clips representing specific emotions and intensities, including happy, sad, angry, fearful, and neutral stimuli.

Secondary Outcomes

  • Self-Reported Graphic version of Personal and Social Performance rating scale #Change from baseline at 20 weeks and 40 weeks(baseline, 20th week, 40th week)
  • Trail Making Test #Change from baseline at 20 weeks and 40 weeks(baseline, 20th week, 40th week)

Study Sites (1)

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