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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
25 Weekly Hours of Music Therapy by an Educated Music Therapist
25 weekly Hours of Being Together with an unknown Care Staff Member
Aalborg University Hospital
Aalborg, North Jutland, Denmark
RECRUITINGChanges from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires
The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.
Time frame: Up til 30 weeks
Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
Quality of Life (WHOQOL-Bref)
Time frame: Up till 30 weeks
Functional Changes from Baseline to Termination. Psychological Questionnaire
Global Assessment of Functioning (GAF)
Time frame: 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.
Time frame: Up to 30 weeks
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