Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness

NCT04428996 | Unknown

• 1 other identifier: B-BR-108-066
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Mental Health Disorder

Keywords

social cognition; Social cognition and interaction training; mental illness

Outcome Measures

Primary Outcomes (4)

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

  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.

  baseline, 20th week, 40th week

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

  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).

  baseline, 20th week, 40th week

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

  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.

  baseline, 20th week, 40th week

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

  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.

  baseline, 20th week, 40th week

Secondary Outcomes (2)

• 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

Other Outcomes (2)

• Brief Psychiatric Rating Scale

  baseline

• Brief Symptom Rating Scale-50 #Change from baseline at 20 weeks and 40 weeks

  baseline, 20th week, 40th week

Study Arms (2)

Arm AB

EXPERIMENTAL

"A" means SCIT program, and "B" means treatment as usual. Arm AB will receive a 60-minutes manual-guide SCIT session each week for 20 times first, then receive treatment as usual. Before the SCIT session, after the SCIT session and after 20 weeks treatment as usual, participants receive evaluations of clinical symptoms, emotional perception, theory of mind, and attributional bias. 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.

Behavioral: Social Cognition and Interaction Training (SCIT)

Arm BA

EXPERIMENTAL

"A" means SCIT program, and "B" means treatment as usual. Arm BA will first receive treatment as usual, then a 60-minutes manual-guide SCIT session each week for 20 times. At the first week, before and after the SCIT session, participants receive evaluations of clinical symptoms, emotional perception, theory of mind, and attributional bias. 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.

Behavioral: Social Cognition and Interaction Training (SCIT)

Interventions

Social Cognition and Interaction Training (SCIT) BEHAVIORAL

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.

Arm AB; Arm BA

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of mental illness

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Yi chia Liu

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Yun Hsu

CONTACT

886-6-2353535; t76054024@gs.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 11, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)