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| Name | Class |
|---|---|
| Aalborg University | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Music Therapy | Experimental | 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
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| Music Listening | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music therapy | Other | 25 Weekly Hours of Music Therapy by an Educated Music Therapist |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires | The Positive and Negative Syndrome Scale (PANSS). Negative Subscale. | Up til 30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire | Quality of Life (WHOQOL-Bref) | Up till 30 weeks |
| Functional Changes from Baseline to Termination. Psychological Questionnaire |
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Inclusion Criteria:
(N1) subdued affect, (N2) emotional withdrawal, (N3) poor contact and (N4) passive/apathetic social withdrawal.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Inge N. Pedersen, PhDAss. Prof | Contact | +45 26229614 | innp@rn.dk | |
| René Ernst Nielsen, PhDAss.Prof | Contact | +45 28722962 | ren@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Inge N. Pedersen, Ass. Prof. | Aalborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | North Jutland | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37200903 | Derived | Hannibal N, Pedersen IN, Bertelsen LR, Nielsen RE, Gold C. Process-outcome relations in music therapy versus music listening for people with schizophrenia viewed through a mediational model: the role of the therapeutic alliance. Front Psychiatry. 2023 May 2;14:1120003. doi: 10.3389/fpsyt.2023.1120003. eCollection 2023. | |
| 34992553 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009147 | Music Therapy |
| ID | Term |
|---|---|
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Music Listening |
| Other |
25 weekly Hours of Being Together with an unknown Care Staff Member |
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Global Assessment of Functioning (GAF)
| 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. | Up to 30 weeks |
| 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. |
| D000359 |
| Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |