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

NCT ID: NCT04428996

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Health Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm AB

"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.

Group Type EXPERIMENTAL

Social Cognition and Interaction Training (SCIT)

Intervention Type 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 BA

"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.

Group Type EXPERIMENTAL

Social Cognition and Interaction Training (SCIT)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yi chia Liu

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wei-Yun Hsu

Role: CONTACT

886-6-2353535 ext. 4365

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Wei-Yun Hsu

Role: primary

886-6-2353535 ext. 4365

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B-BR-108-066

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

The Feasibility of the Peer-based Recovery Program
NCT06897267 ACTIVE_NOT_RECRUITING NA