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Music Therapy Towards Schizophrenia, Negative Symptoms

Primary Purpose

Schizophrenia

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Music therapy
Music Listening
Sponsored by
Inge Nygaard Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring music therapy, double-blinded, Randomized Controlled study (RCT), Schizophrenia, negative symptoms

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aalborg University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Therapy

Music Listening

Arm Description

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 Unique and Essential Principles for Music Therapy with people suffering from Schizophrenia with negative Symptoms, Essential but not Unique Principles, Acceptable but not necessary Principles, 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.

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.

Outcomes

Primary Outcome Measures

Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires
The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.

Secondary Outcome Measures

Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
Quality of Life (WHOQOL-Bref)
Functional Changes from Baseline to Termination. Psychological Questionnaire
Global Assessment of Functioning (GAF)
Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire
Brief negative Symptom Scale (BNSS). Anhedonic Subscale.

Full Information

First Posted
September 20, 2016
Last Updated
July 4, 2019
Sponsor
Inge Nygaard Pedersen
Collaborators
Aalborg University
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1. Study Identification

Unique Protocol Identification Number
NCT02942459
Brief Title
Music Therapy Towards Schizophrenia, Negative Symptoms
Official Title
Music Therapy for Treatment of Patients Suffering From Schizophrenia With Negative Symptoms - A Double-blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
April 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Inge Nygaard Pedersen
Collaborators
Aalborg University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
music therapy, double-blinded, Randomized Controlled study (RCT), Schizophrenia, negative symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
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 Unique and Essential Principles for Music Therapy with people suffering from Schizophrenia with negative Symptoms, Essential but not Unique Principles, Acceptable but not necessary Principles, 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.
Arm Title
Music Listening
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Music therapy
Intervention Description
25 Weekly Hours of Music Therapy by an Educated Music Therapist
Intervention Type
Other
Intervention Name(s)
Music Listening
Intervention Description
25 weekly Hours of Being Together with an unknown Care Staff Member
Primary Outcome Measure Information:
Title
Changes from Baseline at 25 Sessions of Music Therapy in Negative Symptoms. Psychological Questionnaires
Description
The Positive and Negative Syndrome Scale (PANSS). Negative Subscale.
Time Frame
Up til 30 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of Life from Baseline at 25 sessions. Psychological Questionnaire
Description
Quality of Life (WHOQOL-Bref)
Time Frame
Up till 30 weeks
Title
Functional Changes from Baseline to Termination. Psychological Questionnaire
Description
Global Assessment of Functioning (GAF)
Time Frame
Up to 30 weeks
Title
Changes of Anhedonic Features from Baseline at 25 Sessions of Music Therapy. Psychological Questionnaire
Description
Brief negative Symptom Scale (BNSS). Anhedonic Subscale.
Time Frame
Up to 30 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Inge N. Pedersen, PhDAss. Prof
Phone
+45 26229614
Email
innp@rn.dk
First Name & Middle Initial & Last Name or Official Title & Degree
René Ernst Nielsen, PhDAss.Prof
Phone
+45 28722962
Email
ren@rn.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge N. Pedersen, Ass. Prof.
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
State/Province
North Jutland
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inge N. Pedersen, PhDAss. Prof
Phone
+45 26229614
Email
innp@rn.dk
First Name & Middle Initial & Last Name & Degree
René Ernst Nielsen, PhDAss. Prof
Phone
+45 28722962
Email
ren@rn.dk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34992553
Citation
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.
Results Reference
derived

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Music Therapy Towards Schizophrenia, Negative Symptoms

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