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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00137189




Registration number
NCT00137189
Ethics application status
Date submitted
26/08/2005
Date registered
29/08/2005
Date last updated
15/05/2017

Titles & IDs
Public title
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation
Scientific title
Resource-oriented Music Therapy for Psychiatric Patients With Low Therapy Motivation: A Randomised Controlled Trial
Secondary ID [1] 0 0
RCT-MTPSY
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Disorders 0 0
Mood Disorders 0 0
Personality Disorders 0 0
Schizophrenia and Disorders With Psychotic Features 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Schizophrenia
Mental Health 0 0 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: Music therapy - See published study protocol

Other: Standard care - See published study protocol
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Timepoint [1] 0 0
1
Primary outcome [2] 0 0
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
negative symptoms (Scale for the Assessment of Negative Symptoms [SANS])
Timepoint [3] 0 0
9 months
Secondary outcome [1] 0 0
general symptoms
Timepoint [1] 0 0
1
Secondary outcome [2] 0 0
general symptoms
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
general symptoms
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
general functioning
Timepoint [4] 0 0
1 months
Secondary outcome [5] 0 0
general functioning
Timepoint [5] 0 0
3 months
Secondary outcome [6] 0 0
general functioning
Timepoint [6] 0 0
9 months
Secondary outcome [7] 0 0
clinical global impressions
Timepoint [7] 0 0
1 months
Secondary outcome [8] 0 0
clinical global impressions
Timepoint [8] 0 0
3 months
Secondary outcome [9] 0 0
clinical global impressions
Timepoint [9] 0 0
9 months
Secondary outcome [10] 0 0
interest in music
Timepoint [10] 0 0
1 months
Secondary outcome [11] 0 0
interest in music
Timepoint [11] 0 0
3 months
Secondary outcome [12] 0 0
interest in music
Timepoint [12] 0 0
9 months
Secondary outcome [13] 0 0
motivation for change
Timepoint [13] 0 0
1 months
Secondary outcome [14] 0 0
motivation for change
Timepoint [14] 0 0
3 months
Secondary outcome [15] 0 0
motivation for change
Timepoint [15] 0 0
9 months
Secondary outcome [16] 0 0
self-efficacy
Timepoint [16] 0 0
1 months
Secondary outcome [17] 0 0
self-efficacy
Timepoint [17] 0 0
3 months
Secondary outcome [18] 0 0
self-efficacy
Timepoint [18] 0 0
9 months
Secondary outcome [19] 0 0
self-esteem
Timepoint [19] 0 0
1 months
Secondary outcome [20] 0 0
self-esteem
Timepoint [20] 0 0
3 months
Secondary outcome [21] 0 0
self-esteem
Timepoint [21] 0 0
9 months
Secondary outcome [22] 0 0
vitality
Timepoint [22] 0 0
1 months
Secondary outcome [23] 0 0
vitality
Timepoint [23] 0 0
3 months
Secondary outcome [24] 0 0
vitality
Timepoint [24] 0 0
9 months
Secondary outcome [25] 0 0
affect regulation
Timepoint [25] 0 0
1 months
Secondary outcome [26] 0 0
affect regulation
Timepoint [26] 0 0
3 months
Secondary outcome [27] 0 0
affect regulation
Timepoint [27] 0 0
9 months
Secondary outcome [28] 0 0
relational competence
Timepoint [28] 0 0
1 months
Secondary outcome [29] 0 0
relational competence
Timepoint [29] 0 0
3 months
Secondary outcome [30] 0 0
relational competence
Timepoint [30] 0 0
9 months
Secondary outcome [31] 0 0
actual social relationships
Timepoint [31] 0 0
1 months
Secondary outcome [32] 0 0
actual social relationships
Timepoint [32] 0 0
3 months
Secondary outcome [33] 0 0
actual social relationships
Timepoint [33] 0 0
9 months

Eligibility
Key inclusion criteria
* Non-organic mental disorder
* Low therapy motivation
* Willingness to work with music
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Severe mental retardation
* Life-threatening somatic illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
144
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Sunshine Hospital/University of Melbourne, Faculty of Music - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Linz
Country [2] 0 0
Norway
State/province [2] 0 0
Rogaland
Country [3] 0 0
Norway
State/province [3] 0 0
Sogn og Fjordane

Funding & Sponsors
Primary sponsor type
Other
Name
NORCE Norwegian Research Centre AS
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Research Council of Norway
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Helse Vest
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Helse Forde
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Nordfjord Psychiatric Centre
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Government body
Name [5] 0 0
Helse Stavanger HF
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Jæren District Psychiatric Centre
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Individual
Name [7] 0 0
The Wagner-Jauregg Provincial Neuropsychiatric Clinic
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
University of Melbourne
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00137189
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Christian Gold, PhD
Address 0 0
Grieg Academy Music Therapy Research Centre GAMUT, Unifob Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00137189