NCT03882619

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Apr 2019

Shorter than P25 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 13, 2021

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

March 13, 2019

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Calligraphy group

EXPERIMENTAL
Behavioral: Calligraphy

Treatment-as-usual group

NO INTERVENTION

Interventions

CalligraphyBEHAVIORAL

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.

Calligraphy group

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Inpatients
  • With diagnosis of schizophrenia or schizoaffective disorder
  • Not in acute stage
  • Voluntarily participate

You may not qualify if:

  • Severe cognition level or intellectual disability that prevent from participation
  • Severe behavioral problems and symptoms that prevent from participation
  • People with blindness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jianan Psychiatric Center

Tainan, 717, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 20, 2019

Study Start

April 1, 2019

Primary Completion

November 30, 2020

Study Completion

November 30, 2020

Last Updated

January 13, 2021

Record last verified: 2019-08

Locations