Clinical trial NCT02942459: Music Therapy Towards Schizophrenia, Negative Symptoms
Official title: Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: music therapy
double-blinded
Randomized Controlled study (RCT)
Schizophrenia, negative symptoms
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2016-10-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires
timeFrame: Up til 30 weeks
Secondary outcomes:
measure: Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
timeFrame: Up till 30 weeks
measure: Functional Changes from Baseline to Termination. Psychological Questionnaire
timeFrame: Up to 30 weeks
measure: Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire
timeFrame: Up to 30 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: North Jutland
Study officials:
affiliation: Aalborg University
name: Inge N. Pedersen, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pedersen IN, Bonde LO, Hannibal NJ, Nielsen J, Aagaard J, Gold C, Rye Bertelsen L, Jensen SB, Nielsen RE. Music Therapy vs. Music Listening for Negative Symptoms in Schizophrenia: Randomized, Controlled, Assessor- and Patient-Blinded Trial. Front Psychiatry. 2021 Dec 21;12:738810. doi: 10.3389/fpsyt.2021.738810. eCollection 2021.