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Music Therapy Towards Schizophrenia, Negative Symptoms

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02942459
Enrollment
120
Registered
2016-10-24
Start date
2015-09-01
Completion date
2020-12-31
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

music therapy, double-blinded, Randomized Controlled study (RCT), Schizophrenia, negative symptoms

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.

Interventions

OTHERMusic therapy

25 Weekly Hours of Music Therapy by an Educated Music Therapist

OTHERMusic Listening

25 weekly Hours of Being Together with an unknown Care Staff Member

Sponsors

Aalborg University
CollaboratorOTHER
Inge Nygaard Pedersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological QuestionnairesUp til 30 weeksThe Positive and Negative Syndrome Scale (PANSS). Negative Subscale.

Secondary

MeasureTime frameDescription
Change in Quality of Life from Baseline at 25 sessions. Psychological QuestionnaireUp till 30 weeksQuality of Life (WHOQOL-Bref)
Functional Changes from Baseline to Termination. Psychological QuestionnaireUp to 30 weeksGlobal Assessment of Functioning (GAF)
Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological QuestionnaireUp to 30 weeksBrief negative Symptom Scale (BNSS). Anhedonic Subscale.

Countries

Denmark

Contacts

Primary ContactInge N. Pedersen, PhDAss. Prof
innp@rn.dk+45 26229614
Backup ContactRené Ernst Nielsen, PhDAss.Prof
ren@rn.dk+45 28722962

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026