Music Therapy Towards Schizophrenia, Negative Symptoms
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02942459|
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Other: Music therapy Other: Music Listening||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study|
|Actual Study Start Date :||September 1, 2015|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: Music Therapy
25 Weekly Hours of Music Therapy adapted to the Needs of the Participants. Interventions can be Active (playing Music, singing, improvising, Song-writing) or Receptive (Listening to selected Play-lists, or to the Participants´ favored Music).
A Manual is created and trained with the Music Therapists, which distinguishes between
Other: Music therapy
25 Weekly Hours of Music Therapy by an Educated Music Therapist
Active Comparator: Music Listening
25 Weekly Hours of Being together with an unknown Care Staff Member listening to Music from selected Play-Lists. Music Therapists at the Music Therapy Research Clinic at Aalborg University Hospital, Psychiatry have developed Play-Lists in a Taxonomy from very Supportive to less Supportive Music including around 100 Hours of Music all together on the Lists.
A Manual is created and trained with the Care Staff Members. Here the Activities are much more limited (only Music Listening to the Play-Lists are allowed). No Therapeutical Conversation is allowed.
Other: Music Listening
25 weekly Hours of Being Together with an unknown Care Staff Member
- Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires [ Time Frame: Up til 30 weeks ]The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.
- Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire [ Time Frame: Up till 30 weeks ]Quality of Life (WHOQOL-Bref)
- Functional Changes from Baseline to Termination. Psychological Questionnaire [ Time Frame: Up to 30 weeks ]Global Assessment of Functioning (GAF)
- Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire [ Time Frame: Up to 30 weeks ]Brief negative Symptom Scale (BNSS). Anhedonic Subscale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942459
|Contact: Inge N. Pedersen, PhDAss. Prof||+45 email@example.com|
|Contact: René Ernst Nielsen, PhDAss.Prof||+45 firstname.lastname@example.org|
|Aalborg University Hospital||Recruiting|
|Aalborg, North Jutland, Denmark, 9000|
|Contact: Inge N. Pedersen, PhDAss. Prof +45 26229614 email@example.com|
|Contact: René Ernst Nielsen, PhDAss. Prof +45 28722962 firstname.lastname@example.org|
|Principal Investigator:||Inge N. Pedersen, Ass. Prof.||Aalborg University|