SchizophreniaNCT03882619
Effectiveness of Using Calligraphic Activity to People With Schizophrenia
A study testing Calligraphy in people with Schizophrenia, run by The Hong Kong Polytechnic University at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Calligraphy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2019to 30 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Inpatients
- With diagnosis of schizophrenia or schizoaffective disorder
- Not in acute stage
- Voluntarily participate
Who cannot join
- Severe cognition level or intellectual disability that prevent from participation
- Severe behavioral problems and symptoms that prevent from participation
- People with blindness
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Schizophrenia
- Being tested
- Calligraphy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalligraphyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Calligraphy group | Experimental | Not described Receives: Behavioral: Calligraphy |
| Treatment-as-usual group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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.
Measured: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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).
Measured: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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.
Measured: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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).
Measured: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Apr 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Jianan Psychiatric Center, Ministry of Health and Welfare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03882619
- Sponsor's protocol ID
- 19-001
- Status last verified
- Aug 2019
- First submitted
- 13 Mar 2019
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35295614
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Using Calligraphic Activity to People With Schizophrenia
- ClinicalTrials.gov ID
- NCT03882619
- Acronym / sponsor ID
- 19-001
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Jianan Psychiatric Center, Ministry of Health and Welfare
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 20 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calligraphy group | Experimental | Behavioral: Calligraphy |
| Treatment-as-usual group | No intervention | – |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Inpatients
- With diagnosis of schizophrenia or schizoaffective disorder
- Not in acute stage
- Voluntarily participate
Key exclusion criteria (3 listed)
- Severe cognition level or intellectual disability that prevent from participation
- Severe behavioral problems and symptoms that prevent from participation
- People with blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CalligraphyParticipants 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. | Behavioural | Calligraphy group |
Primary outcome
Changes in emotion
Time frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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
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.
Changes in syndrome
Time frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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
Time frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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
Time frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Derived from this study: PubMed 35295614Huang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calligraphy in people with Schizophrenia, run by The Hong Kong Polytechnic University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in emotion (time frame: Changes from baseline, end of study (3 months after baseline), and 6 months after baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03882619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2021.