Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation
Primary Purpose
Mental Disorders, Mood Disorders, Personality Disorders
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Resource-oriented music therapy
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for Mental Disorders focused on measuring Motivation, Music Therapy, Psychotherapy
Eligibility Criteria
Inclusion Criteria: Non-organic mental disorder Low therapy motivation Willingness to work with music Exclusion Criteria: Severe mental retardation Life-threatening somatic illness
Sites / Locations
- Sunshine Hospital/University of Melbourne, Faculty of Music
- Wagner Jauregg Hospital
- Jæren District Psychiatric Centre
- Stavanger University Hospital
- Nordfjord Psychiatry Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Music therapy
Standard care
Arm Description
See published study protocol
See published study protocol
Outcomes
Primary Outcome Measures
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Secondary Outcome Measures
general symptoms
general symptoms
general symptoms
general functioning
general functioning
general functioning
clinical global impressions
clinical global impressions
clinical global impressions
interest in music
interest in music
interest in music
motivation for change
motivation for change
motivation for change
self-efficacy
self-efficacy
self-efficacy
self-esteem
self-esteem
self-esteem
vitality
vitality
vitality
affect regulation
affect regulation
affect regulation
relational competence
relational competence
relational competence
actual social relationships
actual social relationships
actual social relationships
Full Information
NCT ID
NCT00137189
First Posted
August 26, 2005
Last Updated
May 12, 2017
Sponsor
NORCE Norwegian Research Centre AS
Collaborators
The Research Council of Norway, Helse Vest, Helse Forde, Nordfjord Psychiatric Centre, Helse Stavanger HF, Jæren District Psychiatric Centre, The Wagner-Jauregg Provincial Neuropsychiatric Clinic, University of Melbourne
1. Study Identification
Unique Protocol Identification Number
NCT00137189
Brief Title
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation
Official Title
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NORCE Norwegian Research Centre AS
Collaborators
The Research Council of Norway, Helse Vest, Helse Forde, Nordfjord Psychiatric Centre, Helse Stavanger HF, Jæren District Psychiatric Centre, The Wagner-Jauregg Provincial Neuropsychiatric Clinic, University of Melbourne
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes.
Detailed Description
Background: Previous research has shown positive effects of music therapy for people with schizophrenia and other mental disorders. In clinical practice, music therapy is often offered to psychiatric patients with low therapy motivation, but little research exists about this population. The aim of this study is to examine whether resource-oriented music therapy helps psychiatric patients with low therapy motivation to improve negative symptoms and other health-related outcomes. An additional aim of the study is to examine the mechanisms of change through music therapy.
Method: 144 adults with a non-organic mental disorder (ICD-10: F1 to F6) who have low therapy motivation and a willingness to work with music will be randomly assigned to an experimental or a control condition. All participants will receive standard care, and the experimental group will in addition be offered biweekly sessions of music therapy over a period of three months. Outcomes will be measured by a blind assessor before and 1, 3, and 9 months after randomisation.
Discussion: The findings to be expected from this study will fill an important gap in the knowledge of treatment effects for a patient group that does not easily benefit from treatment. The study's close link to clinical practice, as well as its size and comprehensiveness, will make its results well generalisable to clinical practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Disorders, Mood Disorders, Personality Disorders, Schizophrenia and Disorders With Psychotic Features
Keywords
Motivation, Music Therapy, Psychotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music therapy
Arm Type
Experimental
Arm Description
See published study protocol
Arm Title
Standard care
Arm Type
Other
Arm Description
See published study protocol
Intervention Type
Procedure
Intervention Name(s)
Resource-oriented music therapy
Intervention Type
Procedure
Intervention Name(s)
Standard care
Primary Outcome Measure Information:
Title
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Time Frame
1
Title
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Time Frame
3 months
Title
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Time Frame
9 months
Secondary Outcome Measure Information:
Title
general symptoms
Time Frame
1
Title
general symptoms
Time Frame
3 months
Title
general symptoms
Time Frame
9 months
Title
general functioning
Time Frame
1 months
Title
general functioning
Time Frame
3 months
Title
general functioning
Time Frame
9 months
Title
clinical global impressions
Time Frame
1 months
Title
clinical global impressions
Time Frame
3 months
Title
clinical global impressions
Time Frame
9 months
Title
interest in music
Time Frame
1 months
Title
interest in music
Time Frame
3 months
Title
interest in music
Time Frame
9 months
Title
motivation for change
Time Frame
1 months
Title
motivation for change
Time Frame
3 months
Title
motivation for change
Time Frame
9 months
Title
self-efficacy
Time Frame
1 months
Title
self-efficacy
Time Frame
3 months
Title
self-efficacy
Time Frame
9 months
Title
self-esteem
Time Frame
1 months
Title
self-esteem
Time Frame
3 months
Title
self-esteem
Time Frame
9 months
Title
vitality
Time Frame
1 months
Title
vitality
Time Frame
3 months
Title
vitality
Time Frame
9 months
Title
affect regulation
Time Frame
1 months
Title
affect regulation
Time Frame
3 months
Title
affect regulation
Time Frame
9 months
Title
relational competence
Time Frame
1 months
Title
relational competence
Time Frame
3 months
Title
relational competence
Time Frame
9 months
Title
actual social relationships
Time Frame
1 months
Title
actual social relationships
Time Frame
3 months
Title
actual social relationships
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-organic mental disorder
Low therapy motivation
Willingness to work with music
Exclusion Criteria:
Severe mental retardation
Life-threatening somatic illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Gold, PhD
Organizational Affiliation
Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Brynjulf Stige, PhD
Organizational Affiliation
University of Bergen/Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
Official's Role
Study Director
Facility Information:
Facility Name
Sunshine Hospital/University of Melbourne, Faculty of Music
City
Melbourne
Country
Australia
Facility Name
Wagner Jauregg Hospital
City
Linz
ZIP/Postal Code
4021
Country
Austria
Facility Name
Jæren District Psychiatric Centre
City
Bryne
State/Province
Rogaland
ZIP/Postal Code
4349
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
State/Province
Rogaland
ZIP/Postal Code
4068
Country
Norway
Facility Name
Nordfjord Psychiatry Centre
City
Nordfjordeid
State/Province
Sogn og Fjordane
ZIP/Postal Code
6770
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Rolvsjord R, Gold C, Stige B. Research rigour and therapeutic flexibility: Rationale for a therapy manual developed for a randomised controlled trial. Nordic Journal of Music Therapy 14(1):15-32, 2005.
Results Reference
background
PubMed Identifier
16259626
Citation
Gold C, Rolvsjord R, Aaro LE, Aarre T, Tjemsland L, Stige B. Resource-oriented music therapy for psychiatric patients with low therapy motivation: protocol for a randomised controlled trial [NCT00137189]. BMC Psychiatry. 2005 Oct 31;5:39. doi: 10.1186/1471-244X-5-39.
Results Reference
background
PubMed Identifier
23942318
Citation
Gold C, Mossler K, Grocke D, Heldal TO, Tjemsland L, Aarre T, Aaro LE, Rittmannsberger H, Stige B, Assmus J, Rolvsjord R. Individual music therapy for mental health care clients with low therapy motivation: multicentre randomised controlled trial. Psychother Psychosom. 2013;82(5):319-31. doi: 10.1159/000348452. Epub 2013 Aug 9.
Results Reference
result
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Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation
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