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Completed

NCT Number: NCT03882619

Effectiveness of Using Calligraphic Activity to People With Schizophrenia

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).

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

20 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jianan Psychiatric Center

Tainan, 717, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calligraphy

Behavioral

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 outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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).

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Jianan Psychiatric Center, Ministry of Health and Welfare

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 20, 2019
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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