- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137189
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation: A Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Melbourne, Australia
- Sunshine Hospital/University of Melbourne, Faculty of Music
-
-
-
-
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Linz, Austria, 4021
- Wagner Jauregg Hospital
-
-
-
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Rogaland
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Bryne, Rogaland, Norway, 4349
- Jæren District Psychiatric Centre
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Stavanger, Rogaland, Norway, 4068
- Stavanger University Hospital
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Sogn og Fjordane
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Nordfjordeid, Sogn og Fjordane, Norway, 6770
- Nordfjord Psychiatry Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Non-organic mental disorder
- Low therapy motivation
- Willingness to work with music
Exclusion Criteria:
- Severe mental retardation
- Life-threatening somatic illness
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Music therapy
See published study protocol
|
|
OTHER: Standard care
See published study protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Time Frame: 1
|
1
|
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Time Frame: 3 months
|
3 months
|
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Time Frame: 9 months
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
general symptoms
Time Frame: 1
|
1
|
general symptoms
Time Frame: 3 months
|
3 months
|
general symptoms
Time Frame: 9 months
|
9 months
|
general functioning
Time Frame: 1 months
|
1 months
|
general functioning
Time Frame: 3 months
|
3 months
|
general functioning
Time Frame: 9 months
|
9 months
|
clinical global impressions
Time Frame: 1 months
|
1 months
|
clinical global impressions
Time Frame: 3 months
|
3 months
|
clinical global impressions
Time Frame: 9 months
|
9 months
|
interest in music
Time Frame: 1 months
|
1 months
|
interest in music
Time Frame: 3 months
|
3 months
|
interest in music
Time Frame: 9 months
|
9 months
|
motivation for change
Time Frame: 1 months
|
1 months
|
motivation for change
Time Frame: 3 months
|
3 months
|
motivation for change
Time Frame: 9 months
|
9 months
|
self-efficacy
Time Frame: 1 months
|
1 months
|
self-efficacy
Time Frame: 3 months
|
3 months
|
self-efficacy
Time Frame: 9 months
|
9 months
|
self-esteem
Time Frame: 1 months
|
1 months
|
self-esteem
Time Frame: 3 months
|
3 months
|
self-esteem
Time Frame: 9 months
|
9 months
|
vitality
Time Frame: 1 months
|
1 months
|
vitality
Time Frame: 3 months
|
3 months
|
vitality
Time Frame: 9 months
|
9 months
|
affect regulation
Time Frame: 1 months
|
1 months
|
affect regulation
Time Frame: 3 months
|
3 months
|
affect regulation
Time Frame: 9 months
|
9 months
|
relational competence
Time Frame: 1 months
|
1 months
|
relational competence
Time Frame: 3 months
|
3 months
|
relational competence
Time Frame: 9 months
|
9 months
|
actual social relationships
Time Frame: 1 months
|
1 months
|
actual social relationships
Time Frame: 3 months
|
3 months
|
actual social relationships
Time Frame: 9 months
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Christian Gold, PhD, Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
- Study Director: Brynjulf Stige, PhD, University of Bergen/Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RCT-MTPSY
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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