Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-15 @ 12:05 PM
Study NCT ID:
NCT02942459
Status:
UNKNOWN
Last Update Posted:
2019-07-08
First Post:
2016-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Music Therapy Towards Schizophrenia, Negative Symptoms
Sponsor:
Inge Nygaard Pedersen
Organization:
Study Overview
Official Title:
Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: