Clinical trial NCT04428996: Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness
Official title: Social Cognition and Interaction Training (SCIT) for Taiwanese People With Severe Mental Illness
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mental Health Disorder
Keywords: social cognition
Social cognition and interaction training
mental illness
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Test of Theory of mind #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
measure: Ambiguous Intentions Hostility Questionnaire #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
measure: Attributional Style Questionnaire #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
measure: Diagnostic Analysis of Nonverbal Accuracy, Taiwanese version #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
Secondary outcomes:
measure: Self-Reported Graphic version of Personal and Social Performance rating scale #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
measure: Trail Making Test #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
Other outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: baseline
measure: Brief Symptom Rating Scale-50 #Change from baseline at 20 weeks and 40 weeks
timeFrame: baseline, 20th week, 40th week
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Yi chia Liu
role: PRINCIPAL_INVESTIGATOR
References: