- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03882619
Effectiveness of Using Calligraphic Activity to People With Schizophrenia
January 11, 2021 updated by: The Hong Kong Polytechnic University
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).
Study Overview
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tainan, Taiwan, 717
- Jianan Psychiatric Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 64 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Calligraphy group
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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.
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No Intervention: Treatment-as-usual group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in emotion
Time Frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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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).
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Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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Changes in attention
Time Frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
|
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.
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Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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Changes in syndrome
Time Frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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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).
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Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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Changes in cognition
Time Frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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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.
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Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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Changes in quality of life
Time Frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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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).
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Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2019
Primary Completion (Actual)
November 30, 2020
Study Completion (Actual)
November 30, 2020
Study Registration Dates
First Submitted
March 13, 2019
First Submitted That Met QC Criteria
March 19, 2019
First Posted (Actual)
March 20, 2019
Study Record Updates
Last Update Posted (Actual)
January 13, 2021
Last Update Submitted That Met QC Criteria
January 11, 2021
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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