Music Therapy Towards Schizophrenia, Negative Symptoms

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02942459
• Other study ID #: N-20150054
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Aalborg University Hospital
• Contact: Inge N. Pedersen, PhDAss. Prof
• Phone: +45 26229614
• Email: innp[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Other:
• Music therapy
25 Weekly Hours of Music Therapy by an Educated Music Therapist
• Music Listening
25 weekly Hours of Being Together with an unknown Care Staff Member

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	North Jutland

Sponsors (2)

Lead Sponsor	Collaborator
Inge Nygaard Pedersen	Aalborg University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire	Quality of Life (WHOQOL-Bref)	Up till 30 weeks
Secondary	Functional Changes from Baseline to Termination. Psychological Questionnaire	Global Assessment of Functioning (GAF)	Up to 30 weeks
Secondary	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