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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Treatment: Surgery - Resource-oriented music therapy
Treatment: Surgery - Standard care

Experimental: Music therapy - See published study protocol

Other: Standard care - See published study protocol


Treatment: Surgery: Resource-oriented music therapy


Treatment: Surgery: Standard care
Intervention code [1] 0 0
Treatment: Surgery
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
Other
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
Other
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/ct2/show/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.
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/ct2/show/NCT00137189