Effectiveness of Using Calligraphic Activity to People With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effectiveness of Using Calligraphic Activity to People With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03882619
• Other study ID #: 19-001
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2019
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To examine the effects of calligraphy activity on symptoms, attention, emotion, and quality of life in people with schizophrenia. We hypothesized that through a six-month intervention using calligraphy activity, people with schizophrenia will have their symptoms decreased, attention improved, emotion enhanced, and quality of life increased. This study will adopt single-blind, randomized controlled trial, and 160 people with schizophrenia will be recruited in this study. They will be randomly assigned to either a calligraphy activity group (treatment group; n=80) or an occupational activity group (control group; n=80). Participants will complete assessments at pretest, posttest, and 3-month follow-up using the following instruments: Positive and Negative Syndrome Scale (PANSS), Chu's Attention Test, The Taiwanese version of Montreal Cognitive Assessment (MoCA-T), WHO questionnaire on the Quality of Life, Brief Form (WHOQOL-BREF), and Chinese Depression Anxiety Stress Scales(DASS21).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 64 Years

Eligibility

Inclusion Criteria:

• Inpatients
• With diagnosis of schizophrenia or schizoaffective disorder
• Not in acute stage
• Voluntarily participate

Exclusion Criteria:

• Severe cognition level or intellectual disability that prevent from participation
• Severe behavioral problems and symptoms that prevent from participation
• People with blindness

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Behavioral:
• Calligraphy
Participants will (1) detect the emotion him or herself; (2) do the calligraphy activity by writing positive terms (e.g., peace, life); (3) detect emotion again; (4) share the experience with group members.

Locations

Country	Name	City	State
Taiwan	Jianan Psychiatric Center	Tainan

Sponsors (2)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University	Jianan Psychiatric Center, Ministry of Health and Welfare

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in emotion	Emotion is assessed using self-report of Chinese Depression Anxiety Stress Scale. The scale includes three subscales: depression (score range 0-21; higher score indicates higher depression), anxiety (score range 0-21; higher score indicates higher anxiety), and stress (score range 0-21; higher score indicates higher stress).	Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Primary	Changes in attention	Attention is assessed using Chu's Attention Test. The test contains 200 items and is assessed in 10 minutes with two scores calculated: correct number (answered number-number of error answer); rate of correct number (correct number divided by answered number). Higher scores in correct number and rate of correct number indicate better attention.	Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Primary	Changes in syndrome	Symptoms are assessed using Positive and Negative Syndrome Scale. The scale includes three subscales: positive symptom (score range 7-49; higher score indicates more positive symptoms), negative symptoms (score range 7-49; higher score indicates more negative symptoms), and general psychopathology (score range 16-112; higher score indicates more general symptoms).	Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Primary	Changes in cognition	Cognition is assessed using Taiwanese version of Montreal Cognitive Assessment. The score range of the scale is between 0 and 30, a higher score indicates better cognition.	Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Primary	Changes in quality of life	Quality of life is assessed using WHO questionnaire on the Quality of Life, Brief Form. The scale includes four subscales: physical (score range 4-20; higher score indicates better physical quality of life); psychological (score range: 4-20; higher score indicates better psychological quality of life); social (score range: 4-20; higher score indicates better social quality of life); environment (score range: 4-20; higher score indicates better environment quality of life).	Changes from baseline, end of study (3 months after baseline), and 6 months after baseline