Chronic PsychosisNCT04254965
Music Therapy and Bio-psychological Effect Among Chronic Psychiatric Inpatients of a Community Teaching Hospital
A study testing Music therapy and Biosignal analysis in people with Chronic Psychosis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Psychosis
- What is being tested?
- Music therapy and Biosignal analysis
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2020to Dec 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with hearing impairments.
- Patients with no capacity to make juridical acts.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Hsinchu, Hsinchu County, 31064
Cheng-Che Chen, MDMPH, 03-5943248, hugocc@gmail.com
About this study
Official title: Music Therapy Intervention and Bio-psychological Effects Evaluation Among Chronic Psychiatric Inpatients in Rehabilitation Wards of a Community Teaching Hospital
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.
Read the detailed description
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.
- Conditions
- Chronic Psychosis
- Being tested
- Music therapy, Biosignal analysis
- Keywords
- music therapy, chronic psychosis, negative symptoms, occupational therapy, biosignal analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.
Biosignal analysisDevice
Also called iMotions, GSR-Shimmer Module, Dailycare, Fitbit
Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | 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. Receives: Other: Music therapy; Device: Biosignal analysis |
| Group 2 | Active comparator | 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. Receives: Other: Music therapy; Device: Biosignal analysis |
| Group 3 | Sham comparator | Participants in the control group receive their regular occupational therapy during the experimental period. Receives: Device: Biosignal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of negative symptoms of inpatients with psychotic disorders
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Before and 2 months after finishing the music therapy
Secondary outcomes (6)
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
Measured: Two months
Heart Rate Variability in Psychiatric Disorders analysis
Measure Heartbeat variability after intervention activities by "Dailycare" CheckMyHeart
Measured: Two months
Total sleeping time
Recorded by Fitbit health watch
Measured: Two months
Sleep schedule
Recorded by Fitbit health watch, meaning the hours patients are asleep
Measured: Two months
Sleep pattern
Recorded by Fitbit health watch, meaning the distribution of sleep stages (light sleep, deep sleep and rapid eye movement sleep).
Measured: 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.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Chronic PsychosisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Tsing Hua University
- Responsible party
- Sponsor
- Investigators
- Cheng-Che Chen, MDMPH, Principal investigator, National Taiwan University Hospital Chu-Tung Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04254965
- Sponsor's protocol ID
- 201908035RINC
- Status last verified
- Feb 2020
- First submitted
- 5 Jan 2020
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gold C, Rolvsjord R, Aaro LE, Aarre T, Tjemsland L, Stige B. Resource-oriented music therapy for psychiatric patients with low therapy motivation: protocol for a randomised controlled trial [NCT00137189]. BMC Psychiatry. 2005 Oct 31;5:39. doi: 10.1186/1471-244X-5-39.
PubMed 16259626Buccheri R, Trygstad L, Dowling G, Hopkins R, White K, Griffin JJ, Henderson S, Suciu L, Hippe S, Kaas MJ, Covert C, Hebert P. Long-term effects of teaching behavioral strategies for managing persistent auditory hallucinations in schizophrenia. J Psychosoc Nurs Ment Health Serv. 2004 Jan;42(1):18-27. doi: 10.3928/02793695-20040101-09.
PubMed 14768276Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
PubMed 19012672Cook JD. Music as an intervention in the oncology setting. Cancer Nurs. 1986 Feb;9(1):23-8. No abstract available.
PubMed 3518914Wiersma D, Jenner JA, Nienhuis FJ, van de Willige G. Hallucination focused integrative treatment improves quality of life in schizophrenia patients. Acta Psychiatr Scand. 2004 Mar;109(3):194-201. doi: 10.1046/j.0001-690x.2003.00237.x.
PubMed 14984391Morgan KA, Harris AW, Luscombe G, Tran Y, Herkes G, Bartrop RW. The effect of music on brain wave functioning during an acute psychotic episode: a pilot study. Psychiatry Res. 2010 Jul 30;178(2):446-8. doi: 10.1016/j.psychres.2010.04.020. Epub 2010 May 14.
PubMed 20471105Silverman MJ. Psychiatric patients' perception of music therapy and other psychoeducational programming. J Music Ther. 2006 Summer;43(2):111-22. doi: 10.1093/jmt/43.2.111.
PubMed 16897904Peng SM, Koo M, Kuo JC. Effect of group music activity as an adjunctive therapy on psychotic symptoms in patients with acute schizophrenia. Arch Psychiatr Nurs. 2010 Dec;24(6):429-34. doi: 10.1016/j.apnu.2010.04.001. Epub 2010 May 21.
PubMed 21111297Ulrich G, Houtmans T, Gold C. The additional therapeutic effect of group music therapy for schizophrenic patients: a randomized study. Acta Psychiatr Scand. 2007 Nov;116(5):362-70. doi: 10.1111/j.1600-0447.2007.01073.x.
PubMed 17919155Hayashi N, Tanabe Y, Nakagawa S, Noguchi M, Iwata C, Koubuchi Y, Watanabe M, Okui M, Takagi K, Sugita K, Horiuchi K, Sasaki A, Koike I. Effects of group musical therapy on inpatients with chronic psychoses: a controlled study. Psychiatry Clin Neurosci. 2002 Apr;56(2):187-93. doi: 10.1046/j.1440-1819.2002.00953.x.
PubMed 11952923Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.
PubMed 16741859Talwar N, Crawford MJ, Maratos A, Nur U, McDermott O, Procter S. Music therapy for in-patients with schizophrenia: exploratory randomised controlled trial. Br J Psychiatry. 2006 Nov;189:405-9. doi: 10.1192/bjp.bp.105.015073.
PubMed 17077429Hars M, Herrmann FR, Gold G, Rizzoli R, Trombetti A. Effect of music-based multitask training on cognition and mood in older adults. Age Ageing. 2014 Mar;43(2):196-200. doi: 10.1093/ageing/aft163. Epub 2013 Nov 7.
PubMed 24212920Tseng PT, Chen YW, Lin PY, Tu KY, Wang HY, Cheng YS, Chang YC, Chang CH, Chung W, Wu CK. Significant treatment effect of adjunct music therapy to standard treatment on the positive, negative, and mood symptoms of schizophrenic patients: a meta-analysis. BMC Psychiatry. 2016 Jan 26;16:16. doi: 10.1186/s12888-016-0718-8.
PubMed 26812906
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy Intervention and Bio-psychological Effects Evaluation Among Chronic Psychiatric Inpatients in Rehabilitation Wards of a Community Teaching Hospital
- ClinicalTrials.gov ID
- NCT04254965
- Acronym / sponsor ID
- 201908035RINC
- Conditions
- Chronic Psychosis
- Keywords
- music therapy, chronic psychosis, negative symptoms, occupational therapy, biosignal analysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Tsing Hua University
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 5 Feb 2020 (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.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Music therapy, Device: Biosignal analysisParticipants 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. |
| Group 2 | Active comparator | Other: Music therapy, Device: Biosignal analysisParticipants 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. |
| Group 3 | Sham comparator | Device: Biosignal analysisParticipants in the control group receive their regular occupational therapy during the experimental period. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with hearing impairments.
- Patients with no capacity to make juridical acts.
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 |
|---|---|---|
| Music therapyTreatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process. | Other | Group 1, Group 2 |
| Biosignal analysisAlso: iMotions, GSR-Shimmer Module, Dailycare, FitbitMeasurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram. | Device | Group 1, Group 2, Group 3 |
Primary outcome
Change of negative symptoms of inpatients with psychotic disorders
Time frame: Before and immediately after finishing the music therapy
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Change of negative symptoms of inpatients with psychotic disorders
Time frame: Before and 2 months after finishing the music therapy
Using the Scale for the Assessment of Negative Symptoms (in Traditional Chinese)
Change of quality of life
Time frame: Before and immediately after finishing the music therapy
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).
Change of quality of life
Time frame: Before and 2 months after finishing the music therapy
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).
Change of social and interactive skills
Time frame: Before and immediately after finishing the music therapy
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
Change of social and interactive skills
Time frame: Before and 2 months after finishing the music therapy
Using the Assessment of Communication and Interaction Skills scale (in Traditional Chinese)
6 secondary outcomes
Change of facial expression by action landmarks
Time frame: Two months
Heart Rate Variability in Psychiatric Disorders analysis
Time frame: Two months
Total sleeping time
Time frame: Two months
Sleep schedule
Time frame: Two months
Sleep pattern
Time frame: Two months
Motion analysis
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- Background: PubMed 16259626Gold C, Rolvsjord R, Aaro LE, Aarre T, Tjemsland L, Stige B. Resource-oriented music therapy for psychiatric patients with low therapy motivation: protocol for a randomised controlled trial [NCT00137189]. BMC Psychiatry. 2005 Oct 31;5:39. doi: 10.1186/1471-244X-5-39.
- Background: PubMed 14768276Buccheri R, Trygstad L, Dowling G, Hopkins R, White K, Griffin JJ, Henderson S, Suciu L, Hippe S, Kaas MJ, Covert C, Hebert P. Long-term effects of teaching behavioral strategies for managing persistent auditory hallucinations in schizophrenia. J Psychosoc Nurs Ment Health Serv. 2004 Jan;42(1):18-27. doi: 10.3928/02793695-20040101-09.
- Background: PubMed 19012672Acil AA, Dogan S, Dogan O. The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs. 2008 Dec;15(10):808-15. doi: 10.1111/j.1365-2850.2008.01317.x.
- Background: PubMed 3518914Cook JD. Music as an intervention in the oncology setting. Cancer Nurs. 1986 Feb;9(1):23-8. No abstract available.
- Background: PubMed 14984391Wiersma D, Jenner JA, Nienhuis FJ, van de Willige G. Hallucination focused integrative treatment improves quality of life in schizophrenia patients. Acta Psychiatr Scand. 2004 Mar;109(3):194-201. doi: 10.1046/j.0001-690x.2003.00237.x.
- Background: PubMed 20471105Morgan KA, Harris AW, Luscombe G, Tran Y, Herkes G, Bartrop RW. The effect of music on brain wave functioning during an acute psychotic episode: a pilot study. Psychiatry Res. 2010 Jul 30;178(2):446-8. doi: 10.1016/j.psychres.2010.04.020. Epub 2010 May 14.
- Background: PubMed 16897904Silverman MJ. Psychiatric patients' perception of music therapy and other psychoeducational programming. J Music Ther. 2006 Summer;43(2):111-22. doi: 10.1093/jmt/43.2.111.
- Background: PubMed 21111297Peng SM, Koo M, Kuo JC. Effect of group music activity as an adjunctive therapy on psychotic symptoms in patients with acute schizophrenia. Arch Psychiatr Nurs. 2010 Dec;24(6):429-34. doi: 10.1016/j.apnu.2010.04.001. Epub 2010 May 21.
- Background: PubMed 17919155Ulrich G, Houtmans T, Gold C. The additional therapeutic effect of group music therapy for schizophrenic patients: a randomized study. Acta Psychiatr Scand. 2007 Nov;116(5):362-70. doi: 10.1111/j.1600-0447.2007.01073.x.
- Background: PubMed 11952923Hayashi N, Tanabe Y, Nakagawa S, Noguchi M, Iwata C, Koubuchi Y, Watanabe M, Okui M, Takagi K, Sugita K, Horiuchi K, Sasaki A, Koike I. Effects of group musical therapy on inpatients with chronic psychoses: a controlled study. Psychiatry Clin Neurosci. 2002 Apr;56(2):187-93. doi: 10.1046/j.1440-1819.2002.00953.x.
- Background: PubMed 16741859Chou MH, Lin MF. Exploring the listening experiences during guided imagery and music therapy of outpatients with depression. J Nurs Res. 2006 Jun;14(2):93-102. doi: 10.1097/01.jnr.0000387567.41941.14.
- Background: PubMed 17077429Talwar N, Crawford MJ, Maratos A, Nur U, McDermott O, Procter S. Music therapy for in-patients with schizophrenia: exploratory randomised controlled trial. Br J Psychiatry. 2006 Nov;189:405-9. doi: 10.1192/bjp.bp.105.015073.
- Individual participant dataSharing planned: No
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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.
Cheng-Che Chen, MDMPH principal investigator
National Taiwan University Hospital Chu-Tung Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy and Biosignal analysis in people with Chronic Psychosis, run by National Taiwan University Hospital 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 10 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haifan Hsu (0980230620, C10499@chut.ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of negative symptoms of inpatients with psychotic disorders (time frame: Before and immediately after finishing the music therapy). The study lists 6 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 NCT04254965, which also lists 14 linked publications.
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 10 Feb 2020.