An interventional study of Music therapy and Music Listening in Schizophrenia, sponsored by Inge Nygaard Pedersen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-08.
Sponsored by Inge Nygaard Pedersen · Not applicable, Interventional, and Treatment
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.
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:
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's planned enrollment of 120 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →This is the only study on the registry with Inge Nygaard Pedersen as lead sponsor.
Counted across the registry records on this site, refreshed daily.
(N1) subdued affect, (N2) emotional withdrawal, (N3) poor contact and (N4) passive/apathetic social withdrawal.
Exclusion Criteria:
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 1. Unique and Essential Principles for Music Therapy with people suffering from Schizophrenia with negative Symptoms, 2. Essential but not Unique Principles, 3. Acceptable but not necessary Principles, 4. Not acceptable and Proscribed Principles. These Principles concern Attitude and Listening Perspectives by the Music Therapist, how to conduct the Musical Interventions and Questions of Frames for the Music Therapy Work.
Other: Music therapy
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 Music Therapy by an Educated Music Therapist
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
The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.
Time frame: Up til 30 weeks
Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
Quality of Life (WHOQOL-Bref)
Time frame: Up till 30 weeks
Functional Changes from Baseline to Termination. Psychological Questionnaire
Global Assessment of Functioning (GAF)
Time frame: Up to 30 weeks
Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire
Brief negative Symptom Scale (BNSS). Anhedonic Subscale.
Time frame: Up to 30 weeks
Plan to share: No
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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