Music Therapy and Bio-psychological Effect Among Chronic Psychiatric Inpatients of a Community Teaching Hospital

Study Overview
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Brief Summary
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Negative symptoms are an important factor in preventing patients from returning to the community, we aim to assess the effect of music therapy on negative symptoms through this study. Participants of integrated music therapy will receive instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. Other participants will receive passive music listening or regular occupational therapy during the experimental period. Psychiatric symptoms, quality of life, social and interactive skills, and the differences in the physiological signals produced by skin, muscles, and heart will be measured before, after, and two months after the music therapy.

Detailed Description
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Music therapy is gradually being used in the field of psychiatry, such as depression, anxiety, and development disorders in children. However, music therapy still lacks systematic research on chronic mental illness. Since negative symptoms are an important factor in preventing patients from returning to the community, we aim to assess the effect of music therapy on negative symptoms through this study. Additionally, Taiwan as many Asian countries have not yet established a certification system for music therapy. This study cooperates with licensed therapists abroad in the hope of promoting the systematic development of local music therapy in the future. Participants of integrated music therapy (Group 1, integration of active and passive music therapy) includes instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. The four stages of activities are warm-up, main activities, secondary activities, and the ending section. The participants of the music listening group (Group 2, background music listening), music selection based on the musical preference and background of subjects, for relax or boost the spirit of the subjects. Participants in the control group (Group 3) receive their regular occupational therapy during the experimental period. We plan to recruit 100 people in the wards: 40/20/40 (Group 1/2/3) under random assignment. To evaluate the effects of three groups, we measure their psychiatric symptoms, quality of life, social and interactive skills, and the differences in the physiological signals produced by skin, muscles, and heart assisted by a medical engineering scholar before, after, and two months after the music therapy.

Official Title
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Music Therapy Intervention and Bio-psychological Effects Evaluation Among Chronic Psychiatric Inpatients in Rehabilitation Wards of a Community Teaching Hospital

Conditions
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Chronic Psychosis

Intervention / Treatment
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* Other: Music therapy
* Device: Biosignal analysis


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Chronic patient in rehabilitation ward without compulsory hospitalization. Patients with mental, behavioral and neurodevelopmental disorders, including schizophrenia, schizotypal personality disorders, delusional disorders, affective disorders, and organic mental disorders. Exclusion criteria Patients with hearing impairments. Patients with no capacity to make juridical acts.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Participants of integrated music therapy (integration of active and passive music therapy) includes instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. The four stages of activities are warm-up, main activities, secondary activities, and the ending section. | Other: Music therapy<br>* Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.<br>Device: Biosignal analysis<br>* Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.<br>* Other names: DELYSYS TrignoTM Flex;|
| Active Comparator: Group 2<br>Participants of the music listening group will receive background music listening, music selection based on the musical preference and background of subjects, for relax or boost the spirit of the subjects. | Other: Music therapy<br>* Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.<br>Device: Biosignal analysis<br>* Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.<br>* Other names: DELYSYS TrignoTM Flex;|
| Sham Comparator: Group 3<br>Participants in the control group receive their regular occupational therapy during the experimental period. | Device: Biosignal analysis<br>* Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.<br>* Other names: DELYSYS TrignoTM Flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of negative symptoms of inpatients with psychotic disorders | Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese) | Before and immediately after finishing the music therapy | 
| Change of negative symptoms of inpatients with psychotic disorders | Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese) | Before and 2 months after finishing the music therapy | 
| Change of quality of life | Using the World Health Organization Quality of Life-BREF questionnaire (it is a compress name, Traditional Chinese version). The WHOQOL-BREF was derived from data collected using the WHOQOL-100. It produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health. Potential scores for all domain scores range from 4(worse) to 20(better). | Before and immediately after finishing the music therapy | 
| Change of quality of life | Using the World Health Organization Quality of Life-BREF questionnaire (it is a compress name, Traditional Chinese version). The WHOQOL-BREF was derived from data collected using the WHOQOL-100. It produces scores for four domains related to quality of life: physical health, psychological, social relationships and environment. It also includes one facet on overall quality of life and general health. Potential scores for all domain scores range from 4(worse) to 20(better). | Before and 2 months after finishing the music therapy | 
| Change of social and interactive skills | Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese) | Before and immediately after finishing the music therapy | 
| Change of social and interactive skills | Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese) | Before and 2 months after finishing the music therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of facial expression by action landmarks | To evaluate emotion (e.g. anger, fear, disgust, contempt, sadness, and surprise) via facial motion by iMotions device | Two months | 
| Heart Rate Variability in Psychiatric Disorders analysis | Measure Heartbeat variability after intervention activities by Dailycare CheckMyHeart | Two months | 
| Total sleeping time | Recorded by Fitbit health watch | Two months | 
| Sleep schedule | Recorded by Fitbit health watch, meaning the hours patients are asleep | Two months | 
| Sleep pattern | Recorded by Fitbit health watch, meaning the distribution of sleep stages (light sleep, deep sleep and rapid eye movement sleep). | Two months | 
| Motion analysis | Analysis of the electromyography (EMG) of cases recorded by DELYSYS, EMG potentials range between less than 50 μV and up to 30 mV. | Two months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, chronic psychosis, negative symptoms, occupational therapy, biosignal analysis