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Music Therapy Towards Schizophrenia, Negative Symptoms

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ClinicalTrials.gov Identifier: NCT02942459
Recruitment Status : Recruiting
First Posted : October 24, 2016
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Aalborg University
Information provided by (Responsible Party):
Inge Nygaard Pedersen, Aalborg Psychiatric Hospital

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Other: Music therapy Other: Music Listening Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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

  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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire [ Time Frame: Up till 30 weeks ]
    Quality of Life (WHOQOL-Bref)

  2. Functional Changes from Baseline to Termination. Psychological Questionnaire [ Time Frame: Up to 30 weeks ]
    Global Assessment of Functioning (GAF)

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Inge N. Pedersen, PhDAss. Prof +45 26229614 innp@rn.dk
Contact: René Ernst Nielsen, PhDAss.Prof +45 28722962 ren@rn.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, North Jutland, Denmark, 9000
Contact: Inge N. Pedersen, PhDAss. Prof    +45 26229614    innp@rn.dk   
Contact: René Ernst Nielsen, PhDAss. Prof    +45 28722962    ren@rn.dk   
Sponsors and Collaborators
Inge Nygaard Pedersen
Aalborg University
Investigators
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Principal Investigator: Inge N. Pedersen, Ass. Prof. Aalborg University

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Responsible Party: Inge Nygaard Pedersen, Ass. Professor. PhD, Aalborg Psychiatric Hospital
ClinicalTrials.gov Identifier: NCT02942459     History of Changes
Other Study ID Numbers: N-20150054
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Inge Nygaard Pedersen, Aalborg Psychiatric Hospital:
music therapy
double-blinded
Randomized Controlled study (RCT)
Schizophrenia, negative symptoms
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders