Music Therapy Towards Schizophrenia, Negative Symptoms

Study Overview
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Brief Summary
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The Aim of this National study is to examine whether music therapy can reduce negative symptoms and raise Quality of Life for patients suffering from Schizophrenia. It is an Randomized Controlled Trial (RCT), double-blinded study with two arms. 120 Participants are anticipated. The two Arms consist of 25 weekly hours of Music Therapy by educated Music Therapists and time compensated Music Listening by unknown Care Staff Members. The Study is a close Cooperation between Aalborg University (The Music Therapy Research Clinic) and Aalborg University Hospital, Psychiatry.

Detailed Description
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Schizophrenia includes 1 % of the Population in Denmark (DK) and often ends up to be chronically. Negative Symptoms are difficult to reduce by Medication and Psychosocial Treatment Possibilities are searched for. Three Cochrane Reviews (2005, 2011, 2017) have been conducted concerning Music Therapy and Schizophrenia with Positive Results. This RCT, double-blinded Study aims at verifying, if these Results can be Recognized in the Danish Health System. It also aims at being similar to Biomedical Study Designs as much as possible to strengthen the Evidence of the Study. A Power Calculation showed, that a minimum of 44,5 Participants in each Arm should be available, but as drop out can be anticipated with this Population, 60 Participants in each Arm were recommended. The screening Procedure is Comprehensive as it aims at securing, that the negative Symptoms are part of the Illness Schizophrenia and not side Effects from Medication or simultaneous Depression (See the Inclusion- and Exclusion criteria). The Measurement Tools are as follows: At Baseline, after 15 Sessions and at Termination: The Positive and Negative Syndrome Scale (PANSS), Brief Negative Symptom Scale (BNSS), Quality of Life (WHOQOL-Bref), Calgary Depression Scale for Schizophrenia (CDSS), Board of Clinical Examinations (Danish Questionnaire) (UKU) Global Assessment of Functioning Scale (GAF) 4 Weeks after Termination Follow Up Interview. In the Arm of Music Therapy Audio Recording of Music Interventions are done in Session 1,15 and 25. Helping Alliance Questionnaire, patient version, (Haq-II) This Haq-II is filled out after 5 sessions and after 15 Sessions and at Termination together with a Research Assistant in both Arms.

Official Title
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Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study

Conditions
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Schizophrenia

Intervention / Treatment
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* Other: Music therapy
* Other: Music Listening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 - 65 years A Diagnosis of Schizophrenia International Classification of Diseases (ICD-10 (F20)) The Positive and Negative Syndrome Scale (PANNS), negative subscale has to show ≥ 4 on two of the following parameters: (N1) subdued affect, (N2) emotional withdrawal, (N3) poor contact and (N4) passive/apathetic social withdrawal. Exclusion Criteria: Debut of schizophrenia less than 2 years ago. Patients in acute worsening of schizophrenia defined as hospitalization within the last three months. PANNS positive subscale (P1-P7) >28. Patients who have their psychotropics changed within the last months. Significant drug dependency conflicting participation in the study. Presence of secondary symptoms defined as Depression - CDSS score > 7 Neurological side effects - UKU score > 1 in one of the following items: 2.1, 2.2, 2.3, 2.5, 2.6 Sedative side effects - UKU item 1.3 score > 1. No individual music therapy within the last two months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy<br>25 Weekly Hours of Music Therapy adapted to the Needs of the Participants. Interventions can be Active (playing Music, singing, improvising, Song-writing) or Receptive (Listening to selected Play-lists, or to the Participants´ favored Music). A Manual is created and trained with the Music Therapists, which distinguishes between Unique and Essential Principles for Music Therapy with people suffering from Schizophrenia with negative Symptoms, Essential but not Unique Principles, Acceptable but not necessary Principles, Not acceptable and Proscribed Principles. These Principles concern Attitude and Listening Perspectives by the Music Therapist, how to conduct the Musical Interventions and Questions of Frames for the Music Therapy Work. | Other: Music therapy<br>* 25 Weekly Hours of Music Therapy by an Educated Music Therapist<br>|
| Active Comparator: Music Listening<br>25 Weekly Hours of Being together with an unknown Care Staff Member listening to Music from selected Play-Lists. Music Therapists at the Music Therapy Research Clinic at Aalborg University Hospital, Psychiatry have developed Play-Lists in a Taxonomy from very Supportive to less Supportive Music including around 100 Hours of Music all together on the Lists. A Manual is created and trained with the Care Staff Members. Here the Activities are much more limited (only Music Listening to the Play-Lists are allowed). No Therapeutical Conversation is allowed. | Other: Music Listening<br>* 25 weekly Hours of Being Together with an unknown Care Staff Member<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires | The Positive and Negative Syndrome Scale (PANSS). Negative Subscale. | Up til 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire | Quality of Life (WHOQOL-Bref) | Up till 30 weeks | 
| Functional Changes from Baseline to Termination. Psychological Questionnaire | Global Assessment of Functioning (GAF) | Up to 30 weeks | 
| Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire | Brief negative Symptom Scale (BNSS). Anhedonic Subscale. | Up to 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music therapy, double-blinded, Randomized Controlled study (RCT), Schizophrenia, negative symptoms