Schizophrenia Clinical Trial
Official title:
Effectiveness of Using Calligraphic Activity to People With Schizophrenia
NCT number | NCT03882619 |
Other study ID # | 19-001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | November 30, 2020 |
Verified date | August 2019 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Jianan Psychiatric Center | Tainan |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University | Jianan Psychiatric Center, Ministry of Health and Welfare |
Taiwan,
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 |
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