Mental Health DisorderNCT04428996
Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness
A study testing Social Cognition and Interaction Training (SCIT) in people with Mental Health Disorder, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Mental Health Disorder
- What is being tested?
- Social Cognition and Interaction Training (SCIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of mental illness
Who cannot join
- acute hospitalization within the past two months
- other diseases that may affect cognitive function, such as intellectual disability, substance abuse
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Cheng Kung University Hospital
Tainan, 704
Wei-Yun Hsu, 886-6-2353535 ext. 4365, t76054024@gs.ncku.edu.tw
About this study
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.
Read the 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.
- Conditions
- Mental Health Disorder
- Being tested
- Social Cognition and Interaction Training (SCIT)
- Keywords
- social cognition, Social cognition and interaction training, mental illness
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Cognition and Interaction Training (SCIT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Social Cognition and Interaction Training (SCIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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
The PSP scale was developed for assessing patients' function by mental health professions . The rater can assess one global score as well as sub-scores of the four domains: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behaviors. The PSP showed good interrater (ICC = 0.87) and test-retest (ICCs > 0.90) reliability (Patrick et al., 2009) and adequate validity (Cronbach aloha = 0.76) (Kawata \& Revicki, 2008). As many studies showed that people with schizophrenia have greater impairment in processing speed and verbal memory than visual spatial-perception memory, a graphic version of PSP (SRG-PSP) was developed. The results of this SRG-PSP were significantly correlated to those of their corresponding criteria on the PSP. The SRG-PSP total score ranges from 12 to 51, and the higher the score, the better social performance.
Measured: baseline, 20th week, 40th week
Trail Making Test #Change from baseline at 20 weeks and 40 weeks
This is a test to assess visual attention, task conversion, processing speed and cognitive flexibility. Contains two parts. Part A is a number from 1-25, and the subjects must connect the numbers in order. Part B contains 12 numbers and 12 letters. The subjects must connect the numbers and the zodiac in sequence (1-Mouse-2-Bull-3 ...). The scoring method is the individual seconds to complete these two tasks. According to the research by Wang et al. In 2018, this tool has good reliability (ICC> .75).
Measured: baseline, 20th week, 40th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study startJun 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health DisorderStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi chia Liu, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428996
- Sponsor's protocol ID
- B-BR-108-066
- Status last verified
- May 2020
- First submitted
- 21 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT04428996
- Acronym / sponsor ID
- B-BR-108-066
- Conditions
- Mental Health Disorder
- Keywords
- social cognition, Social cognition and interaction training, mental illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm AB | Experimental | Behavioral: Social Cognition and Interaction Training (SCIT)"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. |
| Arm BA | Experimental | Behavioral: Social Cognition and Interaction Training (SCIT)"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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of mental illness
Key exclusion criteria (2 listed)
- acute hospitalization within the past two months
- other diseases that may affect cognitive function, such as intellectual disability, substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Social Cognition and Interaction Training (SCIT)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. | Behavioural | Arm AB, Arm BA |
Primary outcome
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.
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).
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.
2 secondary outcomes
Self-Reported Graphic version of Personal and Social Performance rating scale #Change from baseline at 20 weeks and 40 weeks
Time frame: baseline, 20th week, 40th week
Trail Making Test #Change from baseline at 20 weeks and 40 weeks
Time frame: baseline, 20th week, 40th week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi chia Liu principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social Cognition and Interaction Training (SCIT) in people with Mental Health Disorder, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei-Yun Hsu (886-6-2353535 ext. 4365, t76054024@gs.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Test of Theory of mind #Change from baseline at 20 weeks and 40 weeks (time frame: baseline, 20th week, 40th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.