Effectiveness of Using Calligraphic Activity to People With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Calligraphy
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
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
Sites / Locations
- Jianan Psychiatric Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Calligraphy group
Treatment-as-usual group
Arm Description
Outcomes
Primary Outcome Measures
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 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 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 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 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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03882619
First Posted
March 13, 2019
Last Updated
January 11, 2021
Sponsor
The Hong Kong Polytechnic University
Collaborators
Jianan Psychiatric Center, Ministry of Health and Welfare
1. Study Identification
Unique Protocol Identification Number
NCT03882619
Brief Title
Effectiveness of Using Calligraphic Activity to People With Schizophrenia
Official Title
Effectiveness of Using Calligraphic Activity to People With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
November 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Jianan Psychiatric Center, Ministry of Health and Welfare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calligraphy group
Arm Type
Experimental
Arm Title
Treatment-as-usual group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Calligraphy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in emotion
Description
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).
Time Frame
Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Title
Changes in attention
Description
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.
Time Frame
Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Title
Changes in syndrome
Description
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).
Time Frame
Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Title
Changes in cognition
Description
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.
Time Frame
Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Title
Changes in quality of life
Description
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).
Time Frame
Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Jianan Psychiatric Center
City
Tainan
ZIP/Postal Code
717
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35295614
Citation
Huang WY, Tsang HWH, Wang SM, Huang YC, Chen YC, Cheng CH, Chen CY, Chen JS, Chang YL, Huang RY, Lin CY, Potenza MN, Pakpour AH. Effectiveness of using calligraphic activity to treat people with schizophrenia: a randomized controlled trial in Southern Taiwan. Ther Adv Chronic Dis. 2022 Mar 11;13:20406223221080646. doi: 10.1177/20406223221080646. eCollection 2022.
Results Reference
derived
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Effectiveness of Using Calligraphic Activity to People With Schizophrenia
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